ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Pharmacy PHA

Prescription Drug Costs. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes (H.R.1051). S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. 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. H.R.7148: Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2. H.R.8339: Drug Origin Transparency Act of 2026.

Contacted: White House Office; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Drug Enforcement Administration (DEA); Food & Drug Administration (FDA); Congressional Budget Office (CBO); SENATE

Bills named: H.R. 1051 (119th), H.R. 5526 (119th), H.R. 8339 (119th), S. 1954 (119th), S. 3788 (119th), S. 1414 (119th), H.R. 8269 (119th), H.R. 7148 (119th), S. 3469 (119th)

Medicare/Medicaid MMM

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

Contacted: HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE

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: HOUSE OF REPRESENTATIVES; White House Office; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); SENATE

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

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. Rules of Origin. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. 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: Health & Human Services, Dept of (HHS); SENATE; Office of Management & Budget (OMB); White House Office; Food & Drug Administration (FDA); U.S. Customs & Border Protection; U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC)

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

Budget/Appropriations BUD

FDA Funding.

Contacted: SENATE; HOUSE OF REPRESENTATIVES