ASSOCIATION FOR ACCESSIBLE MEDICINES

PHA · Pharmacy

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.

Literal federal measure citations: H.R.1843, S.1302, S.2296, S.1071, H.R.5526, S.1954, H.R.1051, H.R.4191, S.1784, H.R.4132, S.2027, S.1414, S.3469

MMM · Medicare/Medicaid

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

CPT · Copyright/Patent/Trademark

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).

Literal federal measure citations: H.R.3160, S.1553, H.R.3152, S.1546, H.R.3269, S.2276, S.1041, S.1096, H.R.6485, S.43, S.1040, H.R.5811

TRD · Trade (domestic/foreign)

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.

BUD · Budget/Appropriations

FDA Funding.