ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Copyright/Patent/Trademark CPT

Patent Settlements. Patent Abuse. BPCIA Patent Dance. Inter Partes Review. H.R.4850/S.659: Biologic Patent Transparency Act. Section 101 of the Patent Act.

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

Bills named: H.R. 4850 (116th), S. 659 (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. Medicare Shared Savings Program.

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

Budget/Appropriations BUD

FDA Funding. H.R.133: Consolidated Appropriations Act, 2021.

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

Bills named: H.R. 133 (116th)

Trade (domestic/foreign) TRD

General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-China Trade Discussions.

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

Pharmacy PHA

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

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

Bills named: H.R. 8529 (116th), S. 659 (116th), H.R. 4597 (116th), H.R. 4913 (116th), H.R. 1503 (116th), S. 4134 (116th), H.R. 7507 (116th), H.R. 8479 (116th), S. 2543 (116th), H.R. 4629 (116th), H.R. 5668 (116th), S. 102 (116th), H.R. 8905 (116th), S. 1636 (116th), S. 844 (116th), H.R. 465 (116th), H.R. 938 (116th), H.R. 1520 (116th), S. 1681 (116th), H.R. 6179 (116th), S. 3092 (116th), H.R. 4455 (116th), S. 1895 (116th), H.R. 3 (116th)