BIOTECHNOLOGY INNOVATION ORGANIZATION

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