BIOTECHNOLOGY INNOVATION ORGANIZATION

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

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

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 ---Centers for Disease Control and Prevention Vaccine Programs ---Health Resources and Services Administration (HRSA) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Prescription Drug User Fee Act (PDUFA) VIII Implementation ---VICP/CICP Biodefense Research, Development and Procurement Issues ---H.R.1980: State Strategic Stockpile Act ---H.R.8800: National Defense Authorization Act for Fiscal Year 2027 ---Ebola BDBV Outbreak ---Hanta Virus ---Medical Countermeasure Priority Review Voucher Reauthorization ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) National Security ---H.R.10568: Protecting Biological Data as Critical Infrastructure Act ---H.R.10569: Protecting Biotechnology and Biomanufacturing as Critical Infrastructure Act ---S.3741: Biosecurity Modernization and Innovation Act of 2026 Pandemic Preparedness ---Drug Supply Chain Management ---Medical Countermeasure Priority Review Voucher Reauthorization ---Supply Chain Issues

FY 2026 Appropriations for Agencies ---Administration for Strategic Preparedness and Response (ASPR) ---Biomedical Advanced Research and Development Authority (BARDA) ---Centers for Disease Control and Prevention (CDC) ---Food & Drug Administration (FDA) ---Health Resources and Services Administration (HRSA) ---National Institutes of Health (NIH) FY 2026 Appropriations for Specific Issues ---Antimicrobial Resistance (General) ---Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Funding for Medical Countermeasures ---Funding for Section 317 ---Funding for Strategic National Stockpile ---Pandemic Preparedness - R&D Funding for Medical Countermeasures ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---VICP/CICP Antimicrobial Resistance ---H.R.7352/S.4875: PASTEUR Act of 2026 Biodefense Research, Development and Procurement Issues ---Medical Countermeasure Priority Review Voucher Reauthorization CDC Reform Pandemic Preparedness ---Medical Countermeasure Priority Review Voucher Reauthorization ---R&D Funding for Medical Countermeasures

FY 2026 Appropriations for 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

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 ---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

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