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); Congressional Budget Office (CBO); State, Dept of (DOS); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Commerce, Dept of (DOC); Patent & Trademark Office (PTO); Government Accountability Office (GAO); Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB)

Trade (domestic/foreign) TRD

General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. U.S.-Japan Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Negotiations. China Tariffs.

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

Bills named: H.R. 3379 (116th)

Copyright/Patent/Trademark CPT

Inter Partes Review (IPR) Process. H.R.990/S.344: Hatch-Waxman Integrity Act of 2019. Patent Settlements. Patent Abuse. Section 101 of the Patent Act. New Chemical Entity Exclusivity (NCE). REMEDY Act (Bill number not yet assigned). S.440: Preserving Access to Cost Effective Drugs (PACED) Act. H.R.2375: Preserve Access to Affordable Generics and Biosimilars Act.

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

Bills named: S. 344 (116th), H.R. 990 (116th), H.R. 2375 (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. S.1895: Lower Health Care Costs Act.

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

Bills named: S. 1895 (116th), S. 99 (116th), H.R. 275 (116th), S. 62 (116th), H.R. 1046 (116th), H.R. 448 (116th), S. 377 (116th)

Budget/Appropriations BUD

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

Contacted: Federal Trade Commission (FTC); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); Congressional Budget Office (CBO); HOUSE OF REPRESENTATIVES; SENATE; State, Dept of (DOS); Commerce, Dept of (DOC); Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Office of Management & Budget (OMB); Government Accountability Office (GAO); 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. 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. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. 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. S.1416: Affordable Prescriptions for Patients Act of 2019. S.1224: Stop STALLING 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. S.1895: Lower Health Care Costs 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. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.

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

Bills named: S. 124 (116th), H.R. 1503 (116th), S. 1224 (116th), S. 1895 (116th), S. 475 (116th), H.R. 985 (116th), S. 97 (116th), S. 659 (116th), S. 474 (116th), H.R. 938 (116th), H.R. 1093 (116th), S. 340 (116th), H.R. 447 (116th), H.R. 1520 (116th), S. 378 (116th), S. 61 (116th), S. 1416 (116th), H.R. 1506 (116th), S. 476 (116th), H.R. 3379 (116th), H.R. 965 (116th), S. 64 (116th), S. 102 (116th), S. 440 (116th), H.R. 1499 (116th), H.R. 465 (116th)