ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

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. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. S.1071 - National Defense Authorization Act for Fiscal Year 2026. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: 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. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469 - BIOSECURE Act of 2025. Quotas on Controlled Substances.

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; Food & Drug Administration (FDA); White House Office

Bills named: S. 3469 (119th), H.R. 4132 (119th), S. 2296 (119th), H.R. 5526 (119th), S. 1784 (119th), S. 1414 (119th), S. 1302 (119th), H.R. 1843 (119th), S. 1954 (119th), H.R. 1051 (119th), S. 2027 (119th), H.R. 4191 (119th), S. 1071 (119th)

Medicare/Medicaid MMM

Medicare Part D Reform. Medicaid Rebate Penalty. Medicare/Medicaid Inflation Penalties. Medicare Conditions of Participation.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES

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.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. S.1040: Drug Competition Enhancement Act. PTO rulemaking on inter partes review. H.R.5811: Restoring Americas Leadership in Innovation Act of 2025 (RALIA Act).

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

Bills named: S. 43 (119th), H.R. 3269 (119th), S. 1546 (119th), S. 1041 (119th), S. 1096 (119th), S. 1040 (119th), H.R. 3160 (119th), H.R. 3152 (119th), H.R. 5811 (119th), S. 2276 (119th), H.R. 6485 (119th), S. 1553 (119th)

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. Country of Origin Labeling. Tariffs on Generic Medicines. Quotas on Generic Medicines. Increasing Domestic Production of Generics and Biosimilars. India Trade Negotiations. United States-Mexico-Canada Agreement.

Contacted: U.S. Trade Representative (USTR); SENATE; U.S. Customs & Border Protection; HOUSE OF REPRESENTATIVES; White House Office; Commerce, Dept of (DOC)

Budget/Appropriations BUD

FDA Funding.

Contacted: HOUSE OF REPRESENTATIVES; SENATE