ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Taxation/Internal Revenue Code TAX

Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.

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

Budget/Appropriations BUD

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

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Commerce, Dept of (DOC); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE; Federal Trade Commission (FTC); 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). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. China Tariffs.

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

Copyright/Patent/Trademark CPT

Inter Partes Review (IPR) Process. H.R.990/S.344: Hatch-Waxman Integrity Act of 2019. Patent Settlements. Patent Abuse. S.440: Preserving Access to Cost Effective Drugs (PACED) Act.

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

Bills named: H.R. 990 (116th), S. 344 (116th), S. 440 (116th)

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. H.R.448/S.99: Medicare Drug Price Negotiation Act. H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019. S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019. H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019.

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

Bills named: S. 62 (116th), H.R. 1046 (116th), S. 377 (116th), H.R. 448 (116th), S. 99 (116th), H.R. 275 (116th)

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. Drug Compounding. Drug Shortages. Biosimilars Naming. Biosimilars Insulin. 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.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. S.61: Safe and Affordable Drugs from Canada Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. H.R.447/S.97: Affordable and Safe Prescription Drug Importation Act. S.124: Freedom to Compete Act. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S. 378: Stop Price Gouging Act. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019. S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.

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

Bills named: S. 97 (116th), S. 659 (116th), H.R. 965 (116th), H.R. 1520 (116th), H.R. 1503 (116th), S. 340 (116th), S. 474 (116th), S. 64 (116th), S. 475 (116th), S. 378 (116th), H.R. 1499 (116th), S. 124 (116th), H.R. 447 (116th), S. 476 (116th), H.R. 1506 (116th), S. 102 (116th), H.R. 465 (116th), H.R. 985 (116th), S. 440 (116th), H.R. 938 (116th), S. 61 (116th), H.R. 1093 (116th)