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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 ---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:
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 ---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 ---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
Source: Senate LDA
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
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 ---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
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
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 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
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 ---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 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 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 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
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 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 ---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 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 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 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
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 ---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
Patent Eligibility Restoration Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---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.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
Patent Eligibility Restoration Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
Patent Eligibility Restoration Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
PREVAIL Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
PREVAIL Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
PREVAIL Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---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.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
SBIR/STTR Reauthorization Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
SBIR/STTR Reauthorization Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
SBIR/STTR Reauthorization Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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
ETHIC Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---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.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
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
Helping Startups Continue To Grow Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Helping Startups Continue To Grow Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
Helping Startups Continue To Grow Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Equal Opportunity for All Investors Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Equal Opportunity for All Investors Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Equal Opportunity for All Investors Act of 2025
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
Accredited Investor Definition Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Accredited Investor Definition Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
Accredited Investor Definition Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Small Entity Update Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Small Entity Update Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Small Entity Update Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
Fair Investment Opportunities for Professional Experts Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Fair Investment Opportunities for Professional Experts Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
Fair Investment Opportunities for Professional Experts Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
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
Expanding WKSI Eligibility Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
Expanding WKSI Eligibility Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
INNOVATE Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
INNOVATE Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
INNOVATE Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
To extend the SBIR and STTR programs, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
To extend the SBIR and STTR programs, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
To extend the SBIR and STTR programs, and for other purposes.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
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) ---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) ---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 ---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
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 ---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
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 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 ---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 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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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 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 ---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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---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.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
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 ---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
Skinny Labels, Big Savings Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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) ---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 ---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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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
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
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
CFIUS and Foreign Investment ---H.R.9102: BINSA Act ---Outbound Investment Security Program Drug Importation Drug Pricing ---CMMI: GLOBE and GUARD Models ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Reference Pricing in Drug Reimbursement ---Tariffs Foreign Drug Data Protection Laws ---Implementation of BIOSECURE Act ---Implementation of COINS Global Supply Chain Resiliency Incentives for Domestic Manufacturing Intellectual Property International Enforcement Synthetic Biotech Tariffs ---General ---Section 232 Tariffs on Pharmaceuticals and Pharmaceutical Ingredients US-China Trade Relations ---H.R.9102: BINSA Act ---Implementation of COINS
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Market Liquidity Proposals ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---Implementation of SBIR/STTR reauthorization
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI Assisted Inventions Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act ---Department of Commerce Patent Valuation Fee Proposal ---PTAB Reform ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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
Banking Policy Impacting Emerging Companies ---Regulatory Burden Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act ---H.R.4430: Expanding WKSI Eligibility Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update ---Small Business Capital Formation Enhancement Act Mergers and Acquisitions Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---H.R.8413: SECURE Data Act ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act ---H.R.9142: Prohibiting Adversarial Patents Act of 2026 ---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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2658: Medication Affordability and Patient Integrity Act ---S.3014: Ensuring Timely Access to Generics Act of 2025 ---Department of Commerce Patent Valuation Fee Proposal ---Patent Litigation Reform ---Patent Tax/fees ---PTAB Reform ---Restrictions on Intellectual Property Rights ---Section 101 Modernization Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Intellectual Property Enforcement ---China
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
CFIUS and Foreign Investment ---Outbound Investment Security Program Drug Importation Drug Pricing ---CMMI: GLOBE and GUARD Models ---International Pricing Policies ---Most Favored Nation Drug Pricing Proposals ---Reference Pricing in Drug Reimbursement ---Tariffs Foreign Drug Data Protection Laws ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Implementation of BIOSECURE Act ---Implementation of COINS Global Supply Chain Resiliency Incentives for Domestic Manufacturing Intellectual Property International Enforcement ---China Synthetic Biotech Tariffs Trade Relations ---Section 232 US-China Trade Relations ---H.R.9102: BINSA Act ---Implementation of COINS ---IP Provisions World Health Organization (WHO) ---WHO Pandemic Preparedness Accord
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act Compulsory Licensing ---28 U.S.C. 1498 - Patent and copyright cases Data Privacy ---Data Privacy Working Group Draft ---Implementation of BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL Act ---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.1096: Preserve Access to Affordable Generics and Biosimilars Act ---S.1097: Interagency Patent Coordination and Improvement Act of 2025 ---Patent Tax/fees ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---Implementation of BIOSECURE Act Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---PTAB Reform Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
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
Capital Formation Incentives ---H.R.3323: Helping Startups Continue To Grow Act ---H.R.3339: Equal Opportunity for All Investors Act of 2025 ---H.R.3348: Accredited Investor Definition Review Act ---H.R.3382/S.2924: Small Entity Update Act ---H.R.3394: Fair Investment Opportunities for Professional Experts Act Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---H.R.3169/S.1573: SBIR/STTR Reauthorization Act of 2025 ---H.R.4777: INNOVATE Act ---H.R.5100: To extend the SBIR and STTR programs, and for other purposes. ---S.3971: Small Business Innovation and Economic Security Act
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 ---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 ---Pediatric Priority Review Voucher ---Reauthorization of PAHPA ---Vaccine Access & Compensation
Antitrust Legislation ---General ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy ---BIOSECURE Act Drug Patenting ---H.R.3160/S.1553: PREVAIL 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 of 2025 ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---S.2276: ETHIC Act ---S.2658: Medication Affordability and Patient Integrity Act ---Dept of Commerce Patent Valuation Fee Proposal ---FTC Orange Book Delisting Initiative ---Patent Tax/fees ---PTO Proposed Rules on Terminal Disclaimer Practice ---Prohibiting Adversarial Patents Act (PAPA) Foreign Drug Data Protection Law ---BIOSECURE Act Intellectual Property Enforcement ---China Patent Reform ---H.R.3160/S.1553: PREVAIL Act ---S.1097: Interagency Patent Coordination and Improvement Act ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Prohibiting Adversarial Patents Act (PAPA) Patenting of Biological Inventions ---S.1546/H.R.3152: Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization
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
Banking Policy Impacting Emerging Companies Capital Formation Incentives ---Accredited Investor Definition Review Act ---Adjusting the well-known seasoned issuers definition to allow for a larger financing round using ---American Innovation Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Expanding Access to Capital Act ---Helping Startups Continue to Grow Act ---Small Entity Update Act ---To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes. ---To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes. ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Capital Market Enhancements ---Accredited Investor Definition ---Public Float Threshold Update Sarbanes Oxley Section 404 (b) ---Small Issuer Exemption Small Business Innovation Research (SBIR) Program ---Implementation of the SBIR and STTR Extension Act ---Reauthorization of SBIR and STTR
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
CFIUS and Foreign Investment Drug Importation Drug Pricing ---Most Favored Nation - CMMI Models ---Reference Pricing in Drug Reimbursement Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations Foreign Drug Data Protection Laws ---China Biotechnology Regulations ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes. Intellectual Property International Enforcement ---China Synthetic Biotech Tariffs Trade Relations ---Bilateral Trade Negotiations ---Section 232 ---US-China IP Provisions ---Word Health Organization (WHO) - WHO Pandemic Preparedness Accord
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers ---General Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Data Privacy ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes ---American Privacy Rights Act ---Bio COMPETES (Draft) ---BIOSECURE Act ---Executive Order on Preventing Access to Americans Data from Foreign Adversaries Act Drug Patenting ---A bill to address patent thickets ---S.1546/H.R.3152 Patent Eligibility Restoration Act ---Affordable Prescriptions for Patients Act ---FTC Orange Book Delisting Initiative ---S.1097 Interagency Patent Coordination and Improvement Act of 2025 ---S.2658 Medication Affordability and Patient Integrity Act ---S.1041 Affordable Prescriptions for Patients Act ---S.2276 ETHIC Act ---Dept of Commerce Patent Valuation Fee Proposal ---S.43 Skinny Labels, Big Savings Act ---S.527 Prescription Pricing for the People Act ---S.1096 Preserve Access to Affordable Generics and Biosimilars Act ---Prohibiting Adversarial Patents Act ---H.R.3160/S.1553 PREVAIL Act ---Patent Tax/fees Foreign Drug Data Protection Law ---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 Intellectual Property Enforcement ---China Patent Reform ---Interagency Patent Coordination and Improvement Act ---Patent Eligibility Restoration Act (PERA) ---Patent Litigation Reform ---Prohibiting Adversarial Patents Act (PAPA) ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patenting of Biological Inventions ---Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Intellectual Property Office (WIPO) ---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge
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
Capital Formation Incentives ---Accredited Investor Definition Review Act ---Helping Startups Continue to Grow Act ---Small Entity Update Act Capital Market Enhancements Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR ---Implementation of the SBIR and STTR Extension Act
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 ---General Climate Change ---FY 2025 Appropriations ---FY 2026 Appropriations ---Climate Issues & impact on the agriculture and food sectors Efforts to expand the Bio Economy & Bio Manufacturing ---S.144/H.R.1719 - Farm to Fly Act Farm Bill ---Farm Bill Reauthorization Food & Ag National Security ---China Biotechnology Regulations ---Mexico Decree Banning Genetically Modified Corn Funding for the USDA ---FY 2025 Appropriations ---FY 2026 Appropriations 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 ---USDA Proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Genetically Engineered (GE) Plants ---Climate Issues & impact on the agriculture and food sectors ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) ---EPA Regulatory Approach to Gene Editing ---FDA Proposed guidance on Gene Editing ---International Consistency of Regulations for Gene Edited Products ---USDA Regulatory Approach to Gene Editing Interagency Coordination --- H.R.1326 - DOE and USDA Interagency Research Act Synthetic Biotech Pharmaceutical and Ag Biotech Tariffs USDA/APHIS Agricultural Biotechnology Regulations --- Regulatory Treatment of Gene Edited Products --- USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering --- Regulatory Treatment of Biostimulants United States-Mexico-Canada Agreement (USMCA) ---Implementation of USMCA ---USMCA Review
FY 2026 Appropriations for Agencies ---ASPR ---BARDA --- Centers for Disease Control and Prevention Vaccine Programs --- 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 --- Funding for Strategic National Stockpile --- MCM PRV Reauthorization --- Reauthorization of PAHPA --- 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 (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 Pandemic Preparedness --- Drug Supply Chain Management --- Monoclonal Antibody Coverage and Utilization --- Restrictions on Intellectual Property Rights --- Supply Chain Issues --- Temporarily Refundable R&D Credit --- TRIPS Waiver --- WHO Pandemic Preparedness Accord --- House GOP RFI on Supply Chain --- 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) --- 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
Capital Formation Incentives ---American Innovation Act ---Putting Investors First Act ---Fair Investment Opportunities for Professional Experts Act ---Accredited Investor Definition Review Act ---Helping Startups Continue to Grow Act ---American Innovation and R&D Competitiveness Act ---Small Entity Update Act ---Expanding Access to Capital Act ---American Innovation and Jobs Act ---Implementation of the Inflation Reduction Act (IRA) Capital Market Enhancements ---Accredited Investor Definition ---Amended Definition of Smaller Reporting Company ---Public Float Threshold Update Small Business Innovation Research (SBIR) Program ---Reauthorization of SBIR and STTR ---Implementation of the SBIR and STTR Extension Act
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)
CFIUS and Foreign Investment Drug Importation ---Counterfeit Drug Monitoring Drug Pricing ---Reference Pricing in Drug Reimbursement ---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 ---Most Favored Nation ---Tariffs 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 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 Intellectual Property International Enforcement ---China Synthetic Biotech Tariffs Trade Relations --- United Nations - General --- Section 232 --- US-China Ag-Biotech Provisions --- US China IP Provisions --- World Trade Organization (WTO) - General ---Food and Ag Organization (FAO)
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing Data Privacy ---A bill to prohibit contracting with certain biotechnology providers, and for other purposes ---American Privacy Rights Act ---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 Diversity in Patenting --- Inventor Diversity for Economic Advancement (IDEA) Act 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 ---FTC Orange Book Delisting Initiative ---Interagency Patent Coordination and Improvement Act of 2025 ---Medication Affordability and Patient Integrity Act ---Orange Book Listing ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights ---Stop STALLING Act ---Executive Order 14273: Lowering Drug Prices by Once Again Putting Americans First ---ETHIC Act Foreign Drug Data Protection Law ---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 Intellectual Property Enforcement ---China Patent Reform ---Interagency Patent Coordination and Improvement Act ---Patent Eligibility Restoration Act (PERA) ---Patent Litigation Reform ---Prohibiting Adversarial Patents Act (PAPA) ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act Patenting of Biological Inventions ---Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization World Health Organization (WHO) ---WHO Pandemic Preparedness Accord
Efforts to expand the Bio Economy & Bio Manufacturing ---Farm to Fly Act Farm Bill ---Farm Bill Reauthorization Food & Ag National Security ---China Biotechnology Regulations Genetically Engineered (GE) Animals ---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations Genetically Engineered (GE) Plants ---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs) Issues Relating to Medical Research and Animal Testing Models United States-Mexico-Canada Agreement (USMCA) ---USMCA Review
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
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
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
Biofuels (Non-Funding) ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit 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 ---Infectious Disease Therapies Research and Innovation Act ---Adjusting the well-known seasoned issues definition to allow for a larger financing round using ---American Innovation and Jobs Act ---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Net Operating Loss Advance Refunds ---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards ---Update public float threshold triggers to align with current market conditions Orphan Drug Issues ---Orphan Drug Tax Credit (Camerons Law) ---General Pandemic Preparedness Renewable Chemicals/Bio-based Products (Non-Funding) ---Climate Issues & impact on the agriculture and food sectors Research & Development Tax Credit Reforms ---American Innovation and R&D Competitiveness Act ---Tax Relief for American Families and Workers Act ---American Innovation and Jobs Act ---Expensing of R&D Expenditures ---R&D Payroll Credit Vaccine Injury Compensation Program ---FY 2025 Appropriations ---FY 2026 Appropriations ---Let Injured Americans Be Legally Empowered (LIABLE) Act ---Countermeasure Injury Compensation Fund Amendment Act ---Vaccine Injury Compensation Modernization Act ---Vaccine Access Improvement Act ---VICP ---CICP
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
Antitrust Legislation ---Oversight Pharmacy Benefit Managers Artificial Intelligence (AI) ---Patentability of AI-Aided inventions Bayh-Dole Act/Tech Transfer ---Invent Here, Make Here Act of 2023 (Baldwin) ---Bayh-Dole Act ---March-In Rights ---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights ---Reasonable Pricing Clause Compulsory Licensing Data Privacy Issues ---BIOSECURE Act ---American Privacy Rights Act ---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 in Patenting --- Inventor Diversity for Economic Advancement (IDEA) Act Drug Patenting ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act ---Preserve Access to Affordable Generics and Biosimilars Act ---Stop STALLING Act ---Affordable Prescriptions for Patients Act ---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Medication Affordability and Patient Integrity Act ---A bill to address patent thickets ---A Bill to Amend the FTC Act to Prohibit Product Hopping ---A Bill to Amend U.S.C. Title 35 to Address Infringements of Patents Claiming Biological Products ---Interagency Patent Coordination and Improvement Act of 2025 ---Prescription Pricing for the People Act ---Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI) ---Protecting Consumer Access to Generic Drugs Act ---FTC Orange Book Delisting Initiative ---Orange Book Listing ---PTO Proposed Rules on Terminal Disclaimer Practice ---Restrictions on Intellectual Property Rights Foreign Drug Data Protection Law ---BIOSECURE Act ---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 Intellectual Property Enforcement ---China Patent Reform ---Prohibiting Adversarial Patents Act (PAPA) ---Interagency Patent Coordination and Improvement Act ---Patent Eligibility Restoration Act (PERA) ---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ---Patent Litigation Reform ---The USPTO Request for Comments: Experimental Use Defense 89 Fed. Reg 53963 Patenting of Biological Inventions ---Patent Eligibility Restoration Act (PERA) ---Section 101 Modernization ---RESTORE Patent Rights Act 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
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)