PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Budget/Appropriations BUD

H.Con.Res.14: Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034 S.Con.Res.7 - An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034 H.R. 1968: Full-Year Continuing Appropriations and Extensions Act, 2025 (became Public Law No: 119-4) H.R. 9026: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 H.R. 9027: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 H.R. 9029: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 S. 4690: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2025 S. 4795: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2025 S. 4942: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

Contacted: Executive Office of the President (EOP); SENATE; HOUSE OF REPRESENTATIVES

Bills named: S.Con.Res. 7 (119th), H.R. 9029 (119th), H.Con.Res. 14 (119th), H.R. 9027 (119th), S. 4795 (119th), S. 4690 (119th), S. 4942 (119th), H.R. 1968 (119th), H.R. 9026 (119th)

Copyright/Patent/Trademark CPT

S. 43: Skinny Labels, Big Savings Act S. 708: RESTORE Patent Rights Act of 2025 S. 1040: Drug Competition Enhancement 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 H.R. 890: Stopping Pharmas Ripoffs and Drug Savings For All Act H.R. 1574: RESTORE Patent Rights Act of 2025 Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent use codes policy issues AI patent policy issues Patent eligibility policy issues Post-grant proceeding policy issues Patent submission policy issues

Contacted: Patent & Trademark Office (PTO); SENATE; HOUSE OF REPRESENTATIVES

Bills named: S. 708 (119th), S. 1095 (119th), S. 1040 (119th), S. 1041 (119th), S. 43 (119th), S. 1097 (119th), S. 1096 (119th), H.R. 890 (119th), H.R. 1574 (119th)

Health Issues HCR

S. 652: Protecting Patients from Deceptive Drug Ads Act S. 705: Innovation in Pediatric Drugs Act of 2025 S. 832: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 S. 891: Bipartisan Health Care Act (including section 227 - Modernizing and Ensuring PBM Accountability) S. 932: Give Kids a Chance Act of 2025 H.R. 946: Orphan Cures Act H.R. 1262: Give Kids a Chance Act of 2025 H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R. 2214: DRUG Act Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) Biopharmaceutical innovation policy issues User fee issues Vaccine policy issues Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval policy issues FDA policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues

Contacted: SENATE; HOUSE OF REPRESENTATIVES; President of the U.S.; Executive Office of the President (EOP)

Bills named: H.R. 946 (119th), S. 932 (119th), S. 891 (119th), S. 832 (119th), H.R. 1492 (119th), S. 705 (119th), H.R. 2214 (119th), H.R. 1262 (119th), S. 652 (119th)

Medicare/Medicaid MMM

H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Insulin policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid waiver policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 950 (119th)

Trade (domestic/foreign) TRD

Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues

Contacted: Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); SENATE; President of the U.S.