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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 · third_quarter · Q3
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Source: Senate LDA
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---American Innovation and Jobs Act Incentives for Domestics Manufacturing Orphan Drug Issues ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Implementation of ORPHAN Cures Act ---Pediatric Priority Review Voucher ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act
An act to provide for reconciliation pursuant to title II of H. Con. Res. 14.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---Implementation of ORPHAN Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---American Innovation and R&D Competitiveness Act ---Expensing of R&D Expenditures ---Tax Relief for American Families and Workers Act Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Injury Compensation Modernization Act
Priority for Pediatric Cures Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Priority for Pediatric Cures Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP
Priority for Pediatric Cures Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Protecting Biological Data as Critical Infrastructure Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Protecting Biological Data as Critical Infrastructure Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
Biosimilars Access and Affordability Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Biosimilars Access and Affordability Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Mikaela Naylon Give Kids a Chance Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---American Innovation and Jobs Act Incentives for Domestics Manufacturing Orphan Drug Issues ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Implementation of ORPHAN Cures Act ---Pediatric Priority Review Voucher ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act
Mikaela Naylon Give Kids a Chance Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Mikaela Naylon Give Kids a Chance Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Cameron’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Cameron’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Cameron’s Law
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Maintaining Investments in New Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
State Strategic Stockpile Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Clinical Trial Modernization Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Clinical Trial Modernization Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
340B ACCESS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
340B ACCESS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
340B ACCESS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
340B ACCESS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Safe Step Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Lowering Drug Costs for American Families Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Lowering Drug Costs for American Families Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Lowering Drug Costs for American Families Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
HELP Copays Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
PASTEUR Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
PASTEUR Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance ---H.R.7352/S.4875: PASTEUR Act of 2026 Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures
MVP Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
SECURE Data Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
SECURE Data Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
SECURE Data Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
SECURE Data Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
National Defense Authorization Act for Fiscal Year 2027
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
National Defense Authorization Act for Fiscal Year 2027
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
Federal Biotechnology Workforce Assessment Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Biotechnology Workforce Alignment Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Access to Innovative Treatments Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
ORPHAN Cures Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Tax Exempt Hospital Transparency Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Tax Exempt Hospital Transparency Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Tax Exempt Hospital Transparency Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Tax Exempt Hospital Transparency Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
SECURE 340B Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
SECURE 340B Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Vaccine Injury Compensation Modernization Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Vaccine Injury Compensation Modernization Act of 2026
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP
Affordable Prescriptions for Patients Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Affordable Prescriptions for Patients Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Affordable Prescriptions for Patients Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Stop STALLING Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Preserve Access to Affordable Generics and Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Interagency Patent Coordination and Improvement Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Increasing Transparency in Generic Drug Applications Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Increasing Transparency in Generic Drug Applications Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
Expedited Access to Biosimilars Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1414: Expedited Access to Biosimilars Act ---S.1954: Biosimilar Red Tape Elimination Act ---Biosimilars Competition (General) ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments in New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---H.R.9418: Access to Innovative Treatments Act of 2026 ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1954: Biosimilar Red Tape Elimination Act ---S.3014: Ensuring Timely Access to Generics ---CMMI Authority ---Ensuring Access to Generic Medications Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Tariffs Efforts to Expand the Bioeconomy & Biomanufacturing ---H.R.8930: Federal Biotechnology Workforce Assessment Act ---H.R.8938: Biotechnology Workforce Alignment Act of 2026 Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Drug Benefit Design ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1414: Cameron's Law ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Supply Chain Issues Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.10359: Priority for Pediatric Cures Act ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.5509/S.2903:SAFE STEP Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prior Authorization Reform ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5509/S.2903: SAFE STEP Act ---H.R.7352/S.4875: PASTEUR Act of 2026 ---H.R.9418: Access to Innovative Treatments Act of 2026 ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Senate Discussion Draft - Vaccine Injury Protection Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---H.R.9599: SECURE 340B Act ---S.5244: SUSTAIN 340B Act ---Program Implementation & Oversight ---Rebate Models Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---H.R.10628/S.5571: Biosimilars Access and Affordability Act ---S.1954: Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.7871/S.1637: MVP Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R.1492/S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform Foreign Drug Data Protection Laws ---Regulatory Harmonization Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.6166: Lowering Drug Costs for American Families Act ---H.R.10359: Priority for Pediatric Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---WHO Pandemic Preparedness Accord Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---H.R.1414: Cameron's Law ---H.R.10359: Priority for Pediatric Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---H.R.1414: Cameron's Law ---Expensing of R&D Expenditures Vaccines and Infectious Disease ---H.R.9672: Vaccine Injury Compensation Modernization Act of 2026 ---Senate Discussion Draft - Vaccine Injury Protection Act ---VICP
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance ---H.R.7352/S.4875: PASTEUR Act of 2026 Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 · second_quarter · Q2
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid Services (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Clinical Trial Data From China ---CMMI Models: GLOBE and GUARD ---Funding for Section 317 ---Funding for Strategic National Stockpile ---OMB Federal Research Proposed Rule ---Pandemic Preparedness ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Vaccine Access & Compensation
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV Reauthorization ---Pandemic Flu ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---Gene Editing ---HHS Reorganization ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Centers for Disease Control and Prevention (CDC) ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes Biosimilars ---S.1414: Expedited Access to Biosimilars Act ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China ---Next-Generation U.S. Clinical Development to Accelerate Cures - Legislative Discussion Draft Data Privacy ---H.R.8413: SECURE Data Act ---Clinical Trial Data in China ---Implementation of BIOSECURE Act Diversity & Inclusion ---H.R.3521: Clinical Trial Modernization Act ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---S.3788: CLEAR Labels Act ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Senate Finance Committee Minority RFI on Drug Pricing ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---Generic Drug Application Review Reforms Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---S.822: Scientific EXPERT Act ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---S.1816: Improving Seniors Timely Access to Care Act of 2025 ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Prior Authorization Reform ---SAFE STEP Act ---Step Therapy Vaccines and Infectious Diseases ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---PASTEUR ACT ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.9504: Tax Exempt Hospital Transparency Act ---Program Implementation & Oversight ---PROTECT 340B Act ---Rebate Models ---SECURE 340B Act ---SUSTAIN 340B Act Alternative Funding Programs Biosimilars ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---H.R.8413: SECURE Data Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---CMMI Authority Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Medical Countermeasure Priority Review Voucher Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---VICP/CICP Biodefense Research, Development and Procurement Issues ---Ebola BDBV Outbreak ---Gene Editing ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---WHO Pandemic Preparedness Accord Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of PAHPA ---Supply Chain Issues
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Net Operating Loss Advance Refunds Orphan Drug Issues ---Implementation of ORPHAN Cures Act Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---American Innovation and R&D Competitiveness Act ---Expensing of R&D Expenditures ---Tax Relief for American Families and Workers Act Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Injury Compensation Modernization Act
Filing targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2026 · first_quarter · Q1
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV Reauthorization ---Pandemic Flu ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures
CFIUS and Foreign Investment Drug Pricing ---CMMI: GLOBE and GUARD Models ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Reference Pricing in Drug Reimbursement ---Tariffs Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations Foreign Drug Data Protection Laws ---Implementation of BIOSECURE Act Global Supply Chain Resiliency Incentives for Domestic Manufacturing Intellectual Property International Enforcement ---China Synthetic Biotech ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Tariffs Trade Relations ---Section 232 ---Genetic Resources, and Associated Traditional Knowledge ---World Intellectual Property Office (WIPO) - Treaty on Intellectual Property ---US-China IP Provisions United Nations World Trade Organization (WTO) ---TRIPS Waiver
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---American Innovation and Jobs Act Incentives for Domestics Manufacturing Orphan Drug Issues ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Implementation of ORPHAN Cures Act ---Pediatric Priority Review Voucher ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Rule ---Executive Order on Access to Affordable Life-Saving Medications ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilars Competition (General) ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Clinical Trial Data in China Data Privacy ---Data Privacy Working Group Draft Drug Evaluation and Review ---FDA Hiring Staffing Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---S.43/H.R.6485: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act ---Tariffs Foreign Drug Data Protection Laws Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---International Pricing Policies ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2027 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---H.R.6166: Lowering Drug Costs for American Families Act ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures ---Supply Chain Issues Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---340B Rebate Rule ---CMMI Authority ---National Coverage Determination ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---MCM Manufacturing & Capacity ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---CMMI: GLOBE and GUARD Models ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---Pediatric Priority Review Voucher ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---340B Rebate Rule ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---Implementation of BIOSECURE Act ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilars Competition (General) ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Purple Book Draft Legislation ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---American Privacy Rights Act ---Clinical Trial Data in China ---Consumer Data Privacy and Security Act (Draft) ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA VII Implementation ---PDUFA VIII Negotiations Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Drug Shortages ---Supply Chain Integrity and Traceability ---Contract Manufacturing Ecosystem in the United States Drug Patenting ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.527: Prescription Pricing for the People Act ---S.1095: Stop STALLING Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---Ensuring Access to Generic Medications Act Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biosimilar Red Tape Elimination Act ---CMMI: GLOBE and GUARD Models ---CMMI Authority ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of ORPHAN Cures Act ---International Pricing Policies ---Medicare Drug Price Negotiation Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---National Coverage Determination ---Most Favored Nation Drug Pricing Proposals ---Patient Cost-Sharing and Implementation ---Tariffs Efforts to Expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Generic Drug Entry ---H.R.6485/S.43: Skinny Labels, Big Savings Act ---S.1095: Stop STALLING Act ---S.1302: Increasing Transparency in Generic Drug Applications Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Average Manufacturer Price Calculations ---CMMI (GENEROUS Model) ---CMMI: GLOBE and GUARD Models ---Drug Benefit Design ---International Pricing Policies ---Medicaid VBPs for Patients (MVP) Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---Pricing and Rebates ---Alternative Payment Arrangements for Gene Therapies National Defense ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act of 2027 National Security ---S.3741: Biosecurity Modernization and Innovation Act of 2026 ---Clinical Trial Data in China ---CMMI: GLOBE and GUARD Models ---Implementation of BIOSECURE Act ---International Pricing Policies ---Medical Countermeasure Priority Review Voucher Reauthorization ---NSC/OSTP priorities ---Nucleic acid synthesis security and biotechnology governance ---Most Favored Nation Drug Pricing Proposals Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Implementation of ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Pediatric Priority Review Voucher Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---Pediatric Priority Review Voucher ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---340B Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicaid VBPs for Patients (MVP) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Medical Countermeasure Priority Review Voucher Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---VICP/CICP Biodefense Research, Development and Procurement Issues ---Executive Order on Withdrawing the United States from the World Health Organization ---Implementation of BIOSECURE Act ---Medical Countermeasure Priority Review Voucher Reauthorization ---National Defense Authorization Act 2027 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---State Strategic Stockpile Act ---WHO Pandemic Preparedness Accord Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues ---Medical Countermeasure Priority Review Voucher Reauthorization
FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention ---Centers for Medicare and Medicaid Services (CMS) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CMMI Models: GLOBE and GUARD ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Vaccine Access & Compensation ---Pediatric Priority Review Voucher
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2025 · fourth_quarter · Q4
FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---Creating Hope Reauthorization Act ---Drug Pricing ---Funding for Strategic National Stockpile ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---Project Bioshield ---Reauthorization of PAHPA ---Section 317 Immunization Program ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program 340B Drug Discount Program ---H.R.5256: 340B ACCESS Act ---H.R.6166: Lowering Drug Costs for American Families Act ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---BIOSECURE Act ---House GOP RFI on Supply Chain ---MCM PRV Program Reauthorization ---National Defense Authorization Act 2026 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---State Strategic Stockpile Act ---Synthetic Nucleic Acid Synthesis Screening ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---BIOSECURE Act ---Clinical Trial Data in China Drug Evaluation and Review ---FDA Hiring Flexibility ---PDUFA VIII Negotiations ---Promising Pathway Act Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounding Pharmacies ---Contract Manufacturing Ecosystem in the United States ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.527: Prescription Pricing for the People Act ---S.1041: Affordable Prescriptions for Patients Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.2658: Medication Affordability and Patient Integrity Act ---A bill to address patent thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---S.832: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.1095: Stop STALLING Act ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1302: Increasing Transparency in Generic Drug Application ---Access to Innovative Treatments Act ---Biologics Competition Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Access to Generic Medications Act ---Ensuring Timely Access to Generics ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Negotiation and Competitive Licensing Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation Drug Pricing Proposals ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act Generic Drug Entry ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---The Medicaid VBPs for Patients (MVP) Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Most Favored Nation Pricing Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids a Chance Act ---S.705: Innovation in Pediatric Drugs Act of 2025 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---R&D Funding for Medical Countermeasures ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act Reimbursement and Coverage of Innovative Products ---H.R.6166: Lowering Drug Costs for American Families Act ---S.864/H.R.6423: HELP Copays Act ---Access to Innovative Treatments ---Administrative Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Transparency Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act ---Protected Classes ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---Access to Innovative Treatments Act ---Adult Immunization ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---PASTEUR ACT ---SAFE STEP Act ---Vaccine Access Improvement Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Pandemic Preparedness -R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues (Non-Funding) ---Bio COMPETES (Draft) ---BIOSECURE Act ---Biosecurity Modernization and Innovation Act of 2025 ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---Gene Editing ---HHS Reorganization ---MCM PRV Program ---National Defense Authorization Act 2026 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---WHO Pandemic Preparedness Accord Pandemic Preparedness ---Drug Supply Chain Management ---MCM PRV ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues
FY 2026 Appropriations for Agencies ---ASPR ---BARDA ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institutes of Health FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV Reauthorization ---Pandemic Flu ---Reauthorization of PAHPA ---VICP/CICP Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---HHS Reorganization ---MCM PRV Program CDC Reform Pandemic Preparedness ---MCM PRV Reauthorization ---R&D Funding for Medical Countermeasures
FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Drug Pricing ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Vaccines and Infectious Diseases 340B Drug Discount Program ---340B Rebate Pilot Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---Biosimilars Red Tape Elimination Act ---Reimbursement Cell & Gene Therapy ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Data Privacy ---Bio COMPETES (Draft) Drug Evaluation and Review ---FDA Hiring Flexibility Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Compounded Medicines ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---S.526: Pharmacy Benefit Manager Transparency Act ---S.527: Prescription Pricing for the People Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Most Favored Nation Pricing ---Patient Cost-Sharing and Implementation ---PBM Reform ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws Medicaid ---H.R.6166: Lowering Drug Costs for American Families Act ---S.526: Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Medicaid Drug Rebate Program ---Most Favored Nation in Medicaid ---Pricing and Rebates ---Vaccine Access ---Vaccines for Children Program ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 ---NSCEB Recommendations Opioid Crisis ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932: Mikaela Naylon Give Kids A Chance Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Pediatric Priority Review Voucher Program Reauthorization Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Supply Chain Issues ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864/H.R.6423: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Medicare Part B Physician-Administered Products ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Countermeasures Injury Compensation Program ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives Orphan Drug Issues ---H.R.946/S.1862: ORPHAN Cures Act ---H.R.1262/S.932 Mikaela Naylon Give Kids a Chance Act ---Cameron's Law Pandemic Preparedness Research & Development Tax Credit Reforms ---H.R.1: One Big Beautiful Bill Act ---Expensing of R&D Expenditures ---Tax Incentives for Contract Manufacturing Ecosystem Vaccines and Infectious Disease ---Countermeasure Injury Compensation Fund Amendment Act ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2025 · third_quarter · Q3
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness ---Reauthorization of PAHPA ---Vaccine Access & Compensation
FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health FY 2026 Appropriations for Specific Issues ---Alternative Funding Programs ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---CICP ---Creating Hope Reauthorization Act ---Drug Pricing ---Funding for Strategic National Stockpile ---Funding for Women's Health Research ---Implementation of the Inflation Reduction Act (IRA) ---Influenza Planning & Response ---MCM PRV Reauthorization ---Pandemic Preparedness -R&D Funding for Medical Countermeasures ---PPRV ---Prescription Drug User Fee Act (PDUFA) VII Implementation ---Project Bioshield ---Reauthorization of PAHPA ---Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Section 317 Immunization Program HR 5256 Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues ---BIOSECURE Act ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act ---Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---MCM PRV Program Reauthorization --- National Defense Authorization Act 2026 ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---WHO Pandemic Preparedness Accord Biosimilars ---Biosimilar Copay ---Biosimilar Red Tape Elimination Act ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy Data Privacy ---American Privacy Rights Act ---BIOSECURE Act ---Clinical Trial Data in China Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---H.R. 3521, Clinical Trial Modernization Act Drug Evaluation and Review ---FDA Hiring Flexibility ---Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---A bill to address patent thickets ---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Medication Affordability and Patient Integrity Act ---Patent Thickets ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---S.2082 Stronger Patents Act ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---Biosimilar Red Tape Elimination Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---DRUG Act ---Ensuring Timely Access to Generics ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) ---Increasing Transparency in Generic Drug Application ---Interagency Patent Coordination and Improvement Act ---Lowering Drug Costs for American Families Act ---Mandating Exclusive Review of Individual Treatments (MERIT) Act ---Medicare Drug Price Negotiation Act ---Medicare Negotiation and Competitive Licensing Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Most Favored Nation ---National Coverage Determination ---Patient Cost-Sharing and Implementation ---PBM Reform ---Pharmacy Benefit Manager Transparency Act ---Prescription Drug Price Relief Act ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Protecting Patient Access to Cancer and Therapies ---Strengthening Innovation in Medicare and Medicaid Act ---HR 1 One Big Beautiful Bill Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---BIOSECURE Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. Generic Drug Entry ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Drug Rebate Program Rule ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---Pharmacy Benefit Manager Transparency Act of 2025 ---The Medicaid VBPs for Patients (MVP) Act ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 National Security ---BIOSECURE Act ---Clinical Trial Data in China ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Opioid Crisis ---SUPPORT Act Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids a Chance Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation in Pediatric Drugs Act of 2023 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Medical Countermeasures PRV Reauthorization ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---HR 3493 Global Fairness in Drug Pricing Act ---CMMI Authority ---HELP Copays Act ---National Coverage Determination ---SAFE STEP Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Mandating Exclusive Review of Individual Treatments (MERIT) Act Vaccines and Infectious Diseases ---Adult Immunization ---Antimicrobial Resistance (General) ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---SAFE STEP Act ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---HR 3701 Family Vaccine Protection Act
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---MCM PRV Reauthorization ---Reauthorization of PAHPA ---VICP/CICP ---Prescription Drug User Fee Act (PDUFA) VII Implementation ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Women's Health Research ---Pandemic Preparedness -R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues (Non-Funding) ---BIOSECURE Act ---Risky Research Review Act ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---WHO Pandemic Preparedness Accord ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---HHS Reorganization ---State Strategic Stockpile Act ---National Defense Authorization Act 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---Medical Countermeasure Priority Review Voucher Reauthorization
FY 2026 Appropriations for Agencies ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---BARDA ---ASPR FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) ---MCM PRV Reauthorization ---Reauthorization of PAHPA ---Vaccine Injury Compensation Program (VICP)/CICP ---Funding for Medical Countermeasures ---Pandemic Flu ---Pandemic Preparedness -R&D Funding for Medical Countermeasures Antimicrobial Resistance Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---HHS Reorganization CDC Reform Pandemic Preparedness ---MCM PRV Reauthorization
FY 2026 Appropriations for Specific Issues ---Drug Pricing ---Antimicrobial Resistance (General) ---Vaccines and Infectious Diseases ---Alternative Funding Programs ---Pandemic Preparedness -R&D Funding for Medical Countermeasures 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act Accelerated Approval Antimicrobial Resistance Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Biosimilars Red Tape Elimination Act Cell & Gene Therapy ---H.R.1672 -Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---Promising Pathway Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines Drug Patenting ---Interagency Patent Coordination and Improvement Act ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights ---Patent Thickets ---HR 1 One Big Beautiful Bill Act Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act ---H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---Interagency Patent Coordination and Improvement Act of 2025 ---PBM Reform ---Prescription Drug Pricing for the People Act ---Pharmacy Benefit Manager Transparency Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act ---Most Favored Nation Foreign Drug Data Protection Laws ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Medicaid ---Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Most Favored Nation ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2026 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---S. 946 ORPHAN Cures Act ---Give Kids A Chance Act ---Pediatric Priority Review Voucher Program Reauthorization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Monoclonal Antibody Coverage and Utilization ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---WHO Pandemic Preparedness Accord ---Medical Countermeasure Priority Review Voucher Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act ---Countermeasures Injury Compensation Program ---Vaccine Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
FY 2026 Appropriations for Specific Issues ---Vaccines and Infectious Diseases ---VICP/CICP Capital Formation Incentives ---Helping Startups Continue to Grow Act ---Small Entity Update Act ---Expanding Access to Capital Act ---Equal Opportunity for All Investors Act Orphan Drug Issues ---ORPHAN Cures Act ---Give Kids a Chance Act ---Cameron's Law Pandemic Preparedness Renewable Chemicals/Bio-based Products Research & Development Tax Credit Reforms ---American Innovation and R&D Competitiveness Act ---American Innovation and Jobs Act ---Expensing of R&D Expenditures ---R&D Payroll Credit ---Net Operating Loss Legislation ---HR 1 One Big Beautiful Bill Act Vaccines and Infectious Disease ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act
CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement ---Most Favored Nation Foreign Agricultural Biotechnology Laws and Regulations Foreign Drug Data Protection Laws ---BIOSECURE Act ---Protecting Americans Data from Foreign Adversaries Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) Genetically Engineered (GE) Animals Genetically Engineered (GE) Plants Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Temporarily Refundable R&D Credit Intellectual Property International Enforcement ---China Synthetic Biotech Tariffs Trade Relations ---Section 232 ---World Intellectual Property Office (WIPO) -Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge
Filing targets: Commerce, Dept of (DOC), Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2025 · second_quarter · Q2
FY 2026 Appropriations for Specific Issues ---Drug Pricing ---Antimicrobial Resistance (General) --- Vaccines and Infectious Diseases --- Alternative Funding Programs --- Pandemic Preparedness - R&D Funding for Medical Countermeasures 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight --- PROTECT 340B Act --- SUSTAIN 340B Act Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Biosimilars Red Tape Elimination Act Cell & Gene Therapy --- H.R.1672 - Maintaining Investments and New Innovation (MINI) Act Clinical Trial Data in China Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---Promising Pathway Act ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines Drug Patenting ---Interagency Patent Coordination and Improvement Act ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Restrictions on Intellectual Property Rights ---Patent Thickets Drug Pricing ---H.R.946: ORPHAN Cures Act --- H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act ---Interagency Patent Coordination and Improvement Act of 2025 ---PBM Reform ---Prescription Pricing for the People Act ---Pharmacy Benefit Manager Transparency Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act ---Most Favored Nation Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Medicaid ---Pharmacy Benefit Manager Transparency Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Most Favored Nation ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---S. 946 ORPHAN Cures Act ---Give Kids A Chance Act ---Pediatric Priority Review Voucher Program Reauthorization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness --- Drug Supply Chain Management --- House GOP RFI on Supply Chain --- Monoclonal Antibody Coverage and Utilization --- Restrictions on Intellectual Property Rights --- Supply Chain Issues --- WHO Pandemic Preparedness Accord --- Medical Countermeasure Priority Review Voucher Reauthorization Precision Medicine Initiative Reimbursement and Coverage of Innovative Products --- HR 3375 Fair Prescription Drug Prices for Americans Act --- HR 3493 Global Fairness in Drug Pricing Act --- S.1587 Fair Prescription Drug Prices for Americans Act --- S.1818 Prescription Drug Price Relief Act ---HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---Adult Immunization --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act ---Countermeasures Injury Compensation Program ---Vaccine Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2025 · first_quarter · Q1
Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Climate Issues & impact on the agriculture and food sectors ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization ---FDA Approvals, Guidance, & Regulations ---International Consistency of Regulations for Gene Edited Products
Biodefense Research, Development and Procurement Issues (Non-Funding) ---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---HHS Reorganization ---Executive Order on Achieving Efficiency Through State and Local Preparedness Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---R&D Funding for Medical Countermeasures ---MCM PRV
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2024 · fourth_quarter · Q4
340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2024 · third_quarter · Q3
340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S. 4667 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S. 2780 Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---S.4351: Enhanced Access to Affordable Medicines Act ---H.R 6973: Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433 - Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2024 · second_quarter · Q2
Biodefense Research, Development and Procurement Issues (Non-Funding) --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate --- H.R.3832: Disease X Act of 2023 --- H.R. 3837: Improving Public Health Preparedness Act --- H.R. 3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3) ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---SAFE Risky Research Act ---Tropical Disease Priority Review Voucher (PRV) Program ---Viral Gain of Function Research Moratorium Act ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Womens Health Research Pandemic Preparedness ---R&D Funding for Medical Countermeasures
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2024 · first_quarter · 1A
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2024 · first_quarter · Q1
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2023 · fourth_quarter · Q4
340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 AI Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3832: Disease X Act of 2023 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---American Pandemic Preparedness Plan (AP3) ---WHO Pandemic Accord ---VICP Loopholes ---Reasonable Pricing Clauses in BARDA Contracts Biosimilars ---BIOSIM Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement ---BSUFA Negotiations ---Protecting Consumer Access to Generic Drugs Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Coronavirus (COVID-19) Pandemic ---S.2327: Seniors Prescription Drug Relief Act ---Vaccine And Coverage Certainty (VACC) Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Healthcare Disparities ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Medicare Reimbursement Policies ---In-Home Administration of Part B Drugs ---Drug Supply Chain Management ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change Data Privacy ---American Data Privacy and Protection Act ---Health Data Privacy ---CDC ---NIH Modernization Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---General Drug Importation Drug Manufacturing, Quality & Distribution ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---Restrictions on Intellectual Property Rights ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---CLEAR Patents Act ---H.R.6275: Protecting Consumer Access to Generic Drugs Act of 2023 ---S.3583/H.R.6986 - 118th Cong. A bill to address patent thickets. Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---H.R.5378: Lower Costs, More Transparency Act ---Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.5547/S.476: Maintaining Investments in New Innovation (MINI) Act ---H.R.4531: Support for Patients and Communities Reauthorization Act ---H.R.5539: ORPHAN Cures Act ---H.R.5391/S.2764: Protecting Patient Access to Cancer and Complex Therapies Act ---Small and Large Molecule IRA Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Reasonable Pricing Clauses in BARDA Contracts Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy Funding for National Institutes of Health ---Advanced Research Projects Agency for Health (ARPA-H) Act Gene Therapy Generic Drug Entry ---S.148: Stop STALLING Act ---Generic Drug Application Review Reforms ---S.775: Increasing Transparency in Generic Drug Applications Act Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency bills ---Pricing and Rebates ---Medicaid Drug Rebate Program Rule ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5539: ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---PPRV Reauthorization ---Innovation in Pediatric Drugs Act Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5378: Lower Costs, More Transparency Act ---S.2327: Seniors Prescription Drug Relief Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---H.R.6731/S.3464: The FORWARD Act Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft) ---VICP Loopholes
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2023 · third_quarter · Q3
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---Pandemic Preparedness Plan ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---National Defense Authorization Act for FY 2024 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for National Institutes of Health ---FY 2024 Appropriations
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2023 · second_quarter · 2A
H.R. 2811: Limit, Save, Grow Act of 2023 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---National Vaccine Injury Compensation Program (VICP) Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2023 · second_quarter · Q2
H.R. 2811: Limit, Save, Grow Act of 2023 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---National Vaccine Injury Compensation Program (VICP) Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2023 · first_quarter · Q1
Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---DISARM Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Implementation of USDA Discretion to Provide Support for Biofuel Producers in Consolidated Appropriations Act for FY 2021 Funding for Biorefineries ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Food and Drug Administration Safety and Landmark Advancements Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2022 · fourth_quarter · Q4
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---National Coverage Determination
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2022 · third_quarter · Q3
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Pricing-Related Provisions ---Patient Cost-Sharing and Smoothing Data Privacy ---H.R.8152: American Data Privacy and Protection Act Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.1978/S.912: Protecting Seniors through Immunizations Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2022 · second_quarter · Q2
Coronavirus (COVID-19) Pandemic ---H.R.5376: Build Back Better Act of 2021 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Build Back Better Act (Discussion Draft Senate) ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill ---H.R.5376: Build Back Better Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of Consolidated Appropriations Act for FY 2021 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---FY 2023 Energy and Water Development and Related Agencies funding bill Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Funding for the USDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2022 · first_quarter · Q1
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R. 5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2021 · fourth_quarter · Q4
Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.8080: Health STATISTICS Act of 2020 ---Coronavirus Emerging Growth Companies (EGC) Extension Act (Discussion Draft) ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Immunization Information Systems ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2021 · third_quarter · Q3
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Families First Coronavirus Response Act of 2020 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R. 8920/S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1319: American Rescue Plan Act of 2021 ---H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---H.R. 5376: Build Back Better Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative Funding for FDA ---FY 2022 Budget Resolution --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) Funding for National Institutes of Health ---H.R.133: Consolidated Appropriations Act for FY 2021 ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1319: American Rescue Plan Act of 2021 --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Funding for 2020-2021 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the USDA --- H.R.5305: Extending Government Funding and Delivering Emergency Assistance Act ---Biotechnology and Agriculture Trade Program ---FY 2022 Budget Resolution --- USDA Climate-Smart Agriculture and Forestry Partnership Initiative
FY 2026 Appropriations for Agencies --- Centers for Disease Control and Prevention --- FDA --- Health Resources and Services Administration (HRSA) --- HHS Office of Infectious Disease and HIV/AIDS Policy --- National Institute of Health --- BARDA --- ASPR FY 2026 Appropriations for Specific Issues --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Creating Hope Reauthorization Act --- Funding for Strategic National Stockpile --- Implementation of the Inflation Reduction Act (IRA) --- MCM PRV Reauthorization --- Reauthorization of PAHPA --- Vaccine Injury Compensation Program (VICP) --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Funding for Women's Health Research --- Pandemic Flu --- Pandemic Preparedness - R&D Funding for Medical Countermeasures Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Risky Research Review Act ---Tropical Disease Priority Review Voucher (PRV) Program ---HHS Reorganization ---Executive Order on Achieving Efficiency Through State and Local Preparedness CDC Reform Pandemic Preparedness ---MCM PRV Reauthorization
FY 2026 Appropriations for Specific Issues --- Vaccines and Infectious Diseases --- VICP Biofuels and SAF ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit ---Carbo Capture Utilization Parity Capital Formation Incentives ---American Innovation Act ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Expanding Access to Capital Act ---Equal Opportunity for All Investors Act ---American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) ---Orphan Drug Tax Credit (Camerons Law) Pandemic Preparedness Renewable Chemicals/Bio-based Products ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---American Innovation and R&D Competitiveness Act ---American Innovation and Jobs Act ---Expensing of R&D Expenditures ---R&D Payroll Credit --- Net Operating Loss Legislation --- HR 1 One Big Beautiful Bill Act Vaccines and Infectious Disease ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Countermeasure Injury Compensation Fund Amendment Act ---VICP ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act ---VICP CICP (Discussion Draft)
FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---Department of Energy ---Department of Transportation ---EPA - Office of Biopesticides and Pollution Prevention Division ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---USDA FY 2026 Appropriations for Specific Issues --- Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement ---Biofuels, Biomass Crop Assistance, and Biorefineries ---Biotechnology and Agriculture Trade Program ---Environment and Energy R&D ---Farm Bill Programs Energy Title IX ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act ---NextGen Aircraft Technology - Fuels & Metrics ---Pandemic Preparedness ---Project Bio Shield ---Reauthorization of PAHPA ---Renewable Materials/BIO-based Products ---Vaccine Access & Compensation
FY 2026 Appropriations for Agencies ---ASPR ---Centers for Disease Control and Prevention ---FDA ---Health Resources and Services Administration (HRSA) ---HHS Office of Infectious Disease and HIV/AIDS Policy ---National Institute of Health ---BARDA FY 2026 Appropriations for Specific Issues --- Alternative Funding Programs --- Antimicrobial Resistance (General) --- Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --- CICP --- Creating Hope Reauthorization Act --- Drug Pricing --- Funding for Strategic National Stockpile --- Funding for Women's Health Research --- Implementation of the Inflation Reduction Act (IRA) --- Influenza Planning & Response --- MCM PRV Reauthorization --- Pandemic Preparedness - R&D Funding for Medical Countermeasures --- PPRV --- Prescription Drug User Fee Act (PDUFA) VII Implementation --- Project Bioshield --- Reauthorization of PAHPA --- Vaccines and Infectious Diseases --- Vaccine Injury Compensation Program --- Section 317 Immunization Program 340B Drug Discount Program --- 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues ---Bio COMPETES (Draft) ---Biodefense ---BIOSECURE Act ---Disease X Act ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act ---Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---MCM PRV Program Reauthorization --- NDAA --- Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) --- Risky Research Review Act --- Tropical Disease Priority Review Voucher (PRV) Program --- VICP Loopholes --- WHO Pandemic Preparedness Accord Biosimilars ---Bio COMPETES (Draft) ---Biosimilar Copay ---Biosimilar Red Tape Elimination Act ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Preserve Access to Affordable Generics and Biosimilars Act ---Reimbursement Cell & Gene Therapy --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act Climate Change Data Privacy ---American Privacy Rights Act ---Bio COMPETES (Draft) ---BIOSECURE Act ---Clinical Trial Data in China ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---Promising Pathway Act ---PDUFA ---FDA Reform Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounding & Counterfeit Medicines Drug Patenting ---A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Medication Affordability and Patient Integrity Act ---Patent Thickets ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Restrictions on Intellectual Property Rights ---Stop STALLING Act Drug Pricing ---H.R.946: ORPHAN Cures Act ---H.R. 1492 Ensuring Pathways to Innovative Cures (EPIC) Act --- H.R.1672 Maintaining Investments and New Innovation (MINI) Act --- S.2082 Stronger Patents Act --- Access to Innovative Treatments Act --- Affordable Prescriptions for Patients Act --- Biosimilar Red Tape Elimination Act --- CMMI Authority --- COVID-19 Pricing-Related Provisions --- DRUG Act --- Ensuring Timely Access to Generics --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 --- Implementation of the Inflation Reduction Act (IRA) --- Increasing Transparency in Generic Drug Application --- Interagency Patent Coordination and Improvement Act --- Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act --- Medicare Negotiation and Competitive Licensing Act --- Modernizing and Ensuring PBM Accountability (MEPA) Act --- Most Favored Nation --- National Coverage Determination --- Patient Cost-Sharing and Implementation --- PBM Reform --- Pharmacy Benefit Manager Transparency Act --- Prescription Drug Price Relief Act --- Prescription Pricing for the People Act --- Preserve Access to Affordable Generics and Biosimilars Act --- Protecting Patient Access to Cancer and Therapies --- Stop STALLING Act --- Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Generic Drug Entry --- Stop STALLING Act Issues Relating to Medical Research and Animal Testing ---FDA Modernization Act 3.0 Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design --- Modernizing and Ensuring PBM Accountability (MEPA) Act ---Pharmacy Benefit Manager Transparency Act of 2025 ---Pricing and Rebates --- The Medicaid VBPs for Patients (MVP) Act ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 National Security ---American Privacy Rights Act ---BIOSECURE Act ---Clinical Trial Data in China --- Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics ---SUPPORT Act Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids a Chance Act ---S. 946 ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Innovation in Pediatric Drugs Act of 2023 ---Pediatric Priority Review Voucher Program ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act ---Rare Disease Pilot Program Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain --- Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Medical Countermeasures PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---Project Bio Shield ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Reimbursement and Coverage of Innovative Products --- HR 3375 Fair Prescription Drug Prices for Americans Act --- HR 3493 Global Fairness in Drug Pricing Act --- S.1587 Fair Prescription Drug Prices for Americans Act --- S.1818 Prescription Drug Price Relief Act ---CMMI Authority --- End Price Gauging for Medications Act ---HELP Copays Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Lower Costs, More Transparency Act ---Lowering Drug Costs for American Families Act --- Mandating Exclusive Review of Individual Treatments (MERIT) Act --- Medicare Drug Price Negotiation Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing --- Prescription Drug Price Relief Act ---Protected Classes --- SAFE STEP Act --- SMART Prices Act --- Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations --- The Medicaid VBPs for Patients (MVP) Act ---Value-based Contracting and Communications --- Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases --- Access to Innovative Treatments Act ---Adult Immunization --- Antimicrobial Resistance (General) ---CICP - General --- Countermeasure Injury Compensation Fund Amendment Act --- Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act --- Let Injured Americans Be Legally Empowered (LIABLE) Act --- Maternal Immunization ---MCM Manufacturing & Capacity --- MCM R&D Incentives --- Monoclonal Antibody Coverage and Utilization --- National Coverage Determination --- SAFE STEP Act --- Vaccine Access Improvement Act --- Vaccine and Antimicrobial Resistance Product Development and Incentives --- Vaccine Injury Compensation Modernization Act --- Vaccine Injury Compensation Program --- Vaccine Quality Measure --- Vaccine Safety --- Vaccine Safety Net and Vaccine Infrastructure --- Value of Vaccines and Vaccine Confidence --- VICP CICP (Discussion Draft) ---HR 3701 Family Vaccine Protection Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement ---General Cell & Gene Therapy ---H.R.1672 MINI Act Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations Clinical Trial Data in China Data Privacy ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy ---General Diversity & Inclusion ---Decentralized Clinical Trials ---Clinical Trial Diversity ---General Drug Evaluation and Review ---Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---FY 2026 Appropriations ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---H.R.946: ORPHAN Cures Act ---H.R.1672: Maintaining Investments and New Innovation (MINI) Act ---PBN Reform ---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.526: Prescription Pricing for the People Act of 2025 ---S.527: Pharmacy Benefit Manager Transparency Act of 2025 ---S.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1095: Stop STALLING Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act ---International Reference Pricing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations International Reference Pricing Issues Relating to Medical Research and Animal Testing Models Medicaid ---S.526: Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.946: ORPHAN Cures Act ---H.R.1262: Give Kids A Chance Act ---S.705: Innovation and Pediatric Drugs Act of 2025 ---Pediatric Priority Review Voucher Program Reauthorization ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---General Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2025 Appropriations ---FY 2026 Appropriations ---Adult Immunization ---Countermeasures Injury Compensation Program ---Vaccine Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine Safety and Quality ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---VICP Loopholes
CFIUS and Foreign Investment Drug Importation Drug Pricing ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---International Consistency of Regulation for Gene Edited Products ---Korea Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Foreign Drug Data Protection Laws ---BIOSECURE Act ---Protecting Americans Data from Foreign Adversaries Act ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Global Supply Chain Resiliency ---B5 Coalition on Supply Chain Resiliency ---Issues Relating to Non-Human Primate Shortages Intellectual Property International Enforcement ---China S.2115/H.R.4307 - Medical Supply Chain Resiliency Act Synthetic Biotech Pharmaceutical and Ag Biotech Tariffs US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge World Trade Organization (WTO) ---TRIPS Waiver
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---FY 2026 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---FY 2026 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Material/Bio-based Products ---FY 2025 Appropriations ---FY 2026 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---FY 2025 Appropriations ---FY 2026 Appropriations Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022 Funding for Department of Energy ---Bioenergy Technology Office ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Department of Transportation ---Environmental Energy R&D ---NextGen Aircraft Technology - Fuels & Metrics ---FY 2025 Appropriations ---FY 2026 Appropriations
340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program & Oversight Accelerated Approval Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.854 Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---American Pandemic Preparedness Plan (AP3) ---MCM PRV Program Reauthorization ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---CICP ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy ---H.R.1672: MINI Act Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations Data Privacy ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Data Privacy ---Clinical Trial Data in China Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Clinical Trial Diversity Drug Evaluation and Review ---Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability ---Compounded Medicines ---House GOP RFI on Supply Chain Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Patent Thickets ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---FY 2026 Appropriations ---ORPHAN Cures Act ---Maintaining Investments and New Innovation (MINI) Act ---Ensuring Pathways to Innovative Cures (EPIC) Act ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act of 2025 ---Pharmacy Benefit Manager Transparency Act of 2025 ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---VICP ---CICP Funding for FDA ---FY 2025 Appropriations ---FY 2026 Appropriations ---User Fees Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---FY 2026 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research International Reference Pricing Medicaid ---Pharmacy Benefit Manager Transparency Act of 2025 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.1262: Give Kids a Chance Act ---H.R.946: ORPHAN Cures Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Pediatric Priority Review Voucher Program ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord ---Medical Countermeasures PRV Reauthorization Pharmaceutical and Ag Biotech Tariffs Precision Medicine Initiative Reimbursement and Coverage of Innovative Products ---S.864: HELP Copays Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---FY 2025 Appropriations ---FY 2026 Appropriations ---Adult Immunization ---Countermeasures Injury Compensation Program ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM PRV Reauthorization ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety and Quality ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence ---VICP Loopholes
Biodefense Research, Development and Procurement Issues (Non-Funding) ---State Strategic Stockpile Act ---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---BIOSECURE Act ---Risky Research Review Act ---Bio COMPETES (Draft) ---Gene Editing ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord ---Executive Order on Achieving Efficiency Through State and Local Preparedness ---Executive Order on Withdrawing the United States from the World Health Organization ---HHS Reorganization ---FY 2025 Appropriations ---FY 2026 Appropriations Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---FY 2026 Appropriations ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---FY 2026 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Filing targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3) ---S.4667: Risky Research Review Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---Viral Gain of Function Research Moratorium Act ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for National Institutes of Health ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---MCM PRV ---R&D Funding for Medical Countermeasures
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022
Avian Flu Farm Bill ---Farm Bill Reauthorization Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations ---Farm Bill Reauthorization
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.7085 - BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Gain of Function Research Definition ---Gene Editing ---House GOP RFI on Supply Chain ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---S.2780 - Medication Affordability and Patent Integrity Act ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Creating Hope Reauthorization Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022
340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---S1133: 350B Accountability Act ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---HR 8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.2780 - Medication Affordability and Patent Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate --- H.R.3832: Disease X Act of 2023 --- H.R. 3837: Improving Public Health Preparedness Act --- H.R. 3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3) ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Bio COMPETES (Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---SAFE Risky Research Act ---Tropical Disease Priority Review Voucher (PRV) Program ---Viral Gain of Function Research Moratorium Act ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Womens Health Research Pandemic Preparedness ---MCM PRV ---R&D Funding for Medical Countermeasures
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.7085 - BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Gain of Function Research Definition ---Gene Editing ---House GOP RFI on Supply Chain ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for EPA - Office of Biopesticides and Pollution Prevention Division ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for FDA ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Renewable Chemicals/Bio-based Products ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX ---Implementation of the Inflation Reduction Act (IRA) of 2022 Pandemic Preparedness --- Implementation of the Inflation Reduction Act of 2022
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3631: State Strategic Stockpile Act of 2023 --- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R. 3837: Improving Public Health Preparedness Act ---H.R. 3840: Ensuring Sufficient Supply of Testing Act ---H.R.7085 - BIOSECURE Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gain of Function Research Definition ---Gene Editing --- Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
340B Drug Discount Program ---H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S1133: 350B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change ---FY 2025 Appropriations Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R. 8818: American Privacy Rights Act of 2025 ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act ---Funding for Womens Health Research Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---FY 2025 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---FY 2025 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---RFI for SUSTAIN 340B Act Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---Interchangeability and Pharmacy Substitution ---Reimbursement Coronavirus (COVID-19) Pandemic ---COVID-19 Lessons Learned ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Implementation of Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---American Data Privacy and Protection Act ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---Ranking Member Cassidy RFI on Improving Americans Health Data Privacy Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.3583/H.R.6986: A bill to address patent thickets ---CLEAR Patents Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents, ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---PBM Reform Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act -------At the direction of its core members, BIO advocated on behalf of the biotech industry to avoid supply chain disruptions that would interrupt treatments and cures for patients. During February 2024, BIO coordinated some of this advocacy with WuXiAppTec (then an associate member of BIO) and with other BIO members also, seeking removal of the list of entities specifically named in the proposed legislation being referenced as the BIOSECURE Act, which included WuXiAppTec. ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---FY 2025 Appropriations ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384: Creating Hope Reauthorization Act of 2024 Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---FY 2025 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---MCM PRV Program ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2025 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3832: Disease X Act of 2023 ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---Pandemic Preparedness Plan ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2024 Appropriations ---R&D Funding for Medical Countermeasures Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---National Defense Authorization Act for FY 2024 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for National Institutes of Health ---FY 2024 Appropriations
Coronavirus (COVID-19) Pandemic ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations --- H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---MCM PRV Extension Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R. 3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Gene Editing ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Coronavirus (COVID-19) Pandemic ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---MCM PRV Extension Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2024 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2024 Appropriations Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations Funding for Renewable Chemicals/Bio-based Products ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the USDA ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX House Budget RFI
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R. 3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Gene Editing ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)
340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight ---340B Accountability Act ---General ---H.R.2534: PROTECT 340B Act of 2023 ---RFI Accelerated Approval --- H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs ---General Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---S.2305: Biosimilar Red Tape Elimination Act ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Ensuring Access to Lower-Cost Medicines for Seniors Act Coronavirus (COVID-19) Pandemic ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Healthcare Disparities ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---General Drug Importation ---General Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---AI ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---Restrictions on Intellectual Property Rights ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---CLEAR Patents Act ---Protecting Consumer Access to Generic Drugs Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---H.R.5378: Lower Costs, More Transparency Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2024 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for 2020 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---Enhanced Access to Affordable Medicines Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Medicaid Drug Rebate Program Rule ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Coverage and Reimbursement ---Non-Opioid Analgesics ---FDA Reforms ---NIH Research Orphan Drug Issues ---H.R.5539: ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---General Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5378: Lower Costs, More Transparency Act ---S.2327: Seniors Prescription Drug Relief Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gene Editing ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Government's collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Pandemic Preparedness ---FY 2024 Appropriations ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Fish & Wildlife Service (USFWS), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Government's collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Pandemic Preparedness ---FY 2024 Appropriations ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit
Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate. ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Gene Editing ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Pandemic Preparedness Plan ---Reasonable Pricing ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Zero Draft Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA
340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Fish & Wildlife Service (USFWS), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office
340B Drug Discount Program ---340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act Accelerated Approval Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Disease X ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---BIOSIM Act ---BSUFA Negotiations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Protecting Consumer Access to Generic Drugs Act ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4317: SAFE TO WORK Act ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Access to Generic Drugs Act of 2021 ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Access to Innovative Treatments Act ---Affordable Prescriptions for Patients Act ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Lower Costs, More Cures Act ---National Coverage Determination ---Pharmacy Benefit Manager Transparency Act ---Prescription Pricing for the People Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---National Defense Authorization Act for FY 2023 ---DISARM Act ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---S.148: Stop STALLING Act ---Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.1730: Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.2327: Seniors Prescription Drug Relief Act ---Access to Innovative Treatments Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Access to Innovative Treatments Act ---Adult Immunization ---DISARM Act ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Modernization Act ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Access Improvement Act ---Vaccine Injury Compensation Modernization Act ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---DISARM Act ---National Defense Authorization Act for FY 2023 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for Renewable Chemicals/Bio-based Products ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for the USDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Biotechnology and Agriculture Trade Program ---Farm Bill Programs Energy Title IX
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA
Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Expensing of R&D Expenditures ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---R&D Payroll Credit Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)
Biofuels (Non-Funding) ---H.R.5376: Inflation Reduction Act of 2022 ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Inflation Reduction Act of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Inflation Reduction Act of 2022 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper ---Temporarily Refundable R&D Credit Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic
Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.5376: Inflation Reduction Act of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Funding for the USDA ---FY 2023 Appropriations ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Reauthorization of PAHPA
Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.550: Immunization Information Systems ---Implementation of Consolidated Appropriations Act for FY 2021 ---R&D Funding for Medical Countermeasures ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 --- Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Immunization Information Systems ---Senate HELP Pandemic Preparedness White Paper Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.5376: Build Back Better Act of 2021 --- S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5376: Build Back Better Act of 2021 ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Prescription Drug User Fee Act (PDUFA) VII Discussion Draft Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---S.3799: PREVENT Pandemics Act Funding for Renewable Chemicals/Bio-based Products ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for the USDA ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Farm Bill Programs Energy Title IX
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy Biosimilars ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity ---Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (Discussion Draft) Drug Evaluation and Review ---S.1644: Promising Pathway Act ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Drug Manufacturing, Quality & Distribution ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---Drug Shortages ---Executive Order on Buy American ---Inspections ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Principles Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Generic Drug Entry ---H.R.2883: Stop Stalling Access to Affordable Medications Act Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---Tax Credit Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2022 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2022 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020
Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act Funding for Antimicrobial Resistance (AMR) Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for Strategic National Stockpile ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biofuels, Biomass Crop Assistance, and Biorefineries ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---Climate Issues & impact on the agriculture, food, and forestry sectors ---Incentives for Sustainable Aviation Fuels Funding for Biorefineries ---FY 2022 Appropriations ---Climate Issues & impact on the agriculture, food, and forestry sectors Funding for FDA ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Advanced Research Projects Agency for Health (ARPA-H) Funding for Renewable Chemicals/Bio-based Products ---FY 2022 Appropriations ---H.R.5376: Build Back Better Act of 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2022 Appropriations ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.6119: Further Extending Government Funding Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2022 Appropriations Funding for the USDA ---FY 2022 Appropriations ---H.R.5376: Build Back Better Act of 2021
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office