ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Medicare/Medicaid MMM

Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. CMS RFC on Domestic Manufacturing. CMS Final Rule on Bona Fide Service Fees. HCPCS Codes. Tiering. PBM Bid Transparency.

Contacted: White House Office; Natl Economic Council (NEC); SENATE; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)

Pharmacy PHA

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.9661: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Hassan Purple Book Proposal. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. American Made Medicines Act. PBM Bid Transparency. S.4280: Security And Freedom Enhancement Act of 2026 (SAFE) Act.

Contacted: Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); SENATE; Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); White House Office

Bills named: S. 1302 (119th), H.R. 9661 (119th), S. 3788 (119th), H.R. 8269 (119th), H.R. 4132 (119th), H.R. 4191 (119th), H.R. 1843 (119th), S. 1414 (119th), S. 2027 (119th), S. 1784 (119th), S. 3469 (119th), S. 4280 (119th)

Copyright/Patent/Trademark CPT

H.R.3160/S.1553: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. H.R.3152/S.1546: Patent Eligibility Restoration Act of 2025. H.R.3269/S.2276: Eliminating Thickets to Increase Competition (ETHIC) Act. S.2658: Medication Affordability and Patent Integrity Act. S.1041: Affordable Prescriptions for Patients Act. S.1096: Preserve Access to Affordable Generics and Biosimilars Act. H.R.6485/S.43: Skinny Labels, Big Savings Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act). Settled expectations discretionary denials.

Contacted: SENATE; Congressional Budget Office (CBO); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS)

Bills named: S. 1041 (119th), H.R. 3160 (119th), H.R. 6485 (119th), S. 43 (119th), H.R. 5811 (119th), S. 2658 (119th), S. 1096 (119th), S. 1546 (119th), H.R. 3269 (119th), S. 1553 (119th), H.R. 3152 (119th), S. 2276 (119th)

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement. H.R.8269/S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.

Contacted: Natl Economic Council (NEC); White House Office; Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); U.S. Trade Representative (USTR)

Bills named: S. 3788 (119th), H.R. 8269 (119th)