H.R. 5371: Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 Funding for FDA - FY 2026 Appropriations Federal Budget H.R. 1: One Big Beautiful Bill Act (P.L. 119-21) FY 2027 President's Budget H.R. 6500: Continuing Appropriations and Extensions Act, 2027 (Public Law 119-103)
S. 43: Skinny Labels, Big Savings Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues S. 1546/H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) Restrictions on Intellectual Property Rights PTAB reform Patent fee policy issues Section 101 reform
Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act S. 5244 - SUSTAIN 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies Most Favored Nation (MFN) policy Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027
GENErating cost Reductions for U.S. Medicaid (GENEROUS) model Global Benchmark for Efficient Drug Pricing (GLOBE) Proposed Rule Guarding U.S. Medicare Against Rising Drugs Costs (GUARD) Proposed Rule Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues H.R. 5391/S. 2764 Protecting Patient Access to Cancer and Complex Therapies Act Drug cost and pricing policy issues Medicare rebate policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues
Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms American Innovation and Jobs Act Foreign Direct Investment Expensing of R&D Expenditures Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)
Sec. 301 pharmaceutical tariffs US-UK Framework Agreement Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International pharmaceutical pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs Pharmaceutical manufacturing policy and investment issues Outbound Investment Security Program H.R. 9102/S. 5316 - Biotech Investment National Security Act
Anti-Trust Reform