PREPARE Act

340B Drug Discount Program ---H.R.3290: 340B Drug Discount Program ---Program Implementation & Oversight ---340B Accountability Act ---General ---H.R.2534: PROTECT 340B Act of 2023 ---RFI Accelerated Approval --- H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs ---General Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---Improving Contract Transparency at BARDA Act (Discussion Draft) ---Improving Contract Transparency for the SNS Act (Discussion Draft) ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Biosimilars ---S.2305: Biosimilar Red Tape Elimination Act ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Interchangeability and Pharmacy Substitution ---Reimbursement ---Ensuring Access to Lower-Cost Medicines for Seniors Act Coronavirus (COVID-19) Pandemic ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Healthcare Disparities ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Climate Change ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---General Drug Importation ---General Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---AI ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---Restrictions on Intellectual Property Rights ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---Affordable Prescriptions for Patients Act ---CLEAR Patents Act ---Protecting Consumer Access to Generic Drugs Act ---Restrictions on Intellectual Property Rights ---Draft Double Patenting bill Drug Pricing ---H.R.1790: Biologics Competition Act of 2023 ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---H.R.5378: Lower Costs, More Transparency Act Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---National Defense Authorization Act for FY 2024 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for 2020 ---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for FDA ---FY 2024 Appropriations ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Generic Drug Entry ---S.148: Stop STALLING Act ---Enhanced Access to Affordable Medicines Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid VBPs for Patients (MVP) Act ---Pharmacy Benefit Manager Transparency Act ---Pricing and Rebates ---Medicaid Drug Rebate Program Rule ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---H.R.4531: SUPPORT Act ---Coverage and Reimbursement ---Non-Opioid Analgesics ---FDA Reforms ---NIH Research Orphan Drug Issues ---H.R.5539: ORPHAN Cures Act ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 Precision Medicine Initiative Rare Pediatric Disease Priority Review ---General Reimbursement and Coverage of Innovative Products ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5378: Lower Costs, More Transparency Act ---S.2327: Seniors Prescription Drug Relief Act ---S.652/H.R.2630: Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---Lower Costs, More Cures Act ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $2,200,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)

340B Drug Discount Program ---H.R.2534: PROTECT 340B Act of 2023 ---340B Accountability Act (Discussion Draft) ---Program Implementation & Oversight ---Senate request for information (RFI) on the 340B Drug Pricing Program Accelerated Approval ---H.R.2408: Access to Innovative Treatments Act of 2023 Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3613: Doctors at the Ready Act ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023 ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3813: CDC Leadership Accountability Act ---H.R.3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate ---H.R.3832: Disease X Act of 2023 ---H.R.3837: Improving Public Health Preparedness Act ---H.R.3840: Ensuring Sufficient Supply of Testing Act ---American Pandemic Preparedness Plan (AP3) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---MCM PRV Program ---PHE Congressional Review Act of 2023 (Discussion Draft) ---PHEMCE Advisory Committee Act of 2023 (Discussion Draft) ---Public Health Guidance Transparency and Accountability Act (Discussion Draft) ---Reauthorization of PAHPA ---Tropical Disease Priority Review Voucher (PRV) Program ---White House National Biodefense Strategy Climate Change ---FY 2024 Appropriations ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---American Data Privacy and Protection Act (Discussion Draft) Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Decentralized Clinical Trials Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.476: Maintaining Investments in New Innovation Act ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents ---S.1246: SMART Prices Act ---COVID-19 Pricing-Related Provisions ---Expanding small business exemption in the Inflation Reduction Act (IRA) of 2022 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Reimbursement Policies ---National Coverage Determination ---Patient Cost-Sharing and Smoothing Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance (AMR) Programs ---FY 2024 Appropriations ---H.R.2940/S.1355: PASTEUR Act ---DISARM Act (Discussion Draft) ---National Defense Authorization Act for FY 2024 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2024 Appropriations ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2024 Appropriations ---H.R.2408: Access to Innovative Treatments Act of 2023 ---Funding for 2024-2025 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---FY 2024 Appropriations ---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft) ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2024 Appropriations Funding for National Institutes of Health ---FY 2024 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2024 Appropriations Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Incentives for Generic Entry Medicaid ---Pricing and Rebates Opioid Crisis ---SUPPORT Act (Discussion Draft) Orphan Drug Issues ---Expanding drug exclusion in the Inflation Reduction Act (IRA) of 2022 ---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit ---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft) Pandemic Preparedness ---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---Implementation of the Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Rare Pediatric Disease Priority Review ---Helping Experts Accelerate Rare Treatments (HEART) Act (Discussion Draft) ---Speeding Therapy Access Today (STAT) Act (Discussion Draft) Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---S.652/H.R.2630 Safe Step Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act (Discussion Draft) ---Medicare Drug Price Negotiation Act (Discussion Draft) ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Prescription Drug Price Relief Act (Discussion Draft) ---Protected Classes ---Seniors Prescription Drug Relief Act (Discussion Draft) ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2024 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2940/S.1355: PASTEUR Act ---Adult Immunization ---DISARM Act (Discussion Draft) ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine and Coverage Certainty (VACC) Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2024 Appropriations ---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft) ---Vaccine Access Improvement Act (Discussion Draft) ---Vaccine Injury Compensation Modernization Act (Discussion Draft) ---VICP CICP (Discussion Draft)