ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Taxation/Internal Revenue Code TAX

Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.

Contacted: SENATE; Federal Trade Commission (FTC); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR)

Trade (domestic/foreign) TRD

General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. United States-Mexico-Canada Agreement (USMCA). China Tariffs.

Contacted: U.S. Trade Representative (USTR); Federal Trade Commission (FTC); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); SENATE; Centers For Medicare and Medicaid Services (CMS)

Copyright/Patent/Trademark CPT

Inter Partes Review (IPR) Process. H.R.7251/S.3738: Hatch-Waxman Integrity Act of 2018. Patent Settlements. S.1390: STRONGER Patents Act of 2017. S.2514: PACED Act.

Contacted: U.S. Trade Representative (USTR); SENATE; Commerce, Dept of (DOC); Federal Trade Commission (FTC); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Bills named: S. 3738 (115th), S. 2514 (115th), H.R. 7251 (115th), S. 1390 (115th)

Medicare/Medicaid MMM

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Food & Drug Administration (FDA); Federal Trade Commission (FTC); U.S. Trade Representative (USTR)

Budget/Appropriations BUD

FDA Funding. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.

Contacted: Food & Drug Administration (FDA); Federal Trade Commission (FTC); SENATE; Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)

Pharmacy PHA

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.

Contacted: U.S. Trade Representative (USTR); SENATE; Centers For Medicare and Medicaid Services (CMS); Federal Trade Commission (FTC); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS)

Bills named: H.R. 2562 (115th), S. 974 (115th), H.R. 1223 (115th), H.R. 5002 (115th), S. 124 (115th), H.R. 7348 (115th), S. 3680 (115th), S. 771 (115th), S. 1509 (115th), S. 1131 (115th), H.R. 6577 (115th), H.R. 2212 (115th), S. 297 (115th), S. 3775 (115th), S. 3519 (115th), S. 3792 (115th), S. 469 (115th), H.R. 2051 (115th), H.R. 749 (115th), S. 1115 (115th), H.R. 1245 (115th), H.R. 449 (115th), H.R. 2439 (115th), H.R. 6 (115th)