ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

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

Bills named: S. 1366 (117th), S. 1367 (117th), S. 1203 (117th), H.R. 2870 (117th), S. 1176 (117th), H.R. 2653 (117th)

Copyright/Patent/Trademark CPT

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

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

Bills named: H.R. 2884 (117th), H.R. 2891 (117th), S. 1428 (117th), S. 1435 (117th), H.R. 153 (117th), H.R. 2873 (117th)

Medicare/Medicaid MMM

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.

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

Bills named: H.R. 2868 (117th), S. 1427 (117th), H.R. 2846 (117th), H.R. 2869 (117th), H.R. 2815 (117th)

Budget/Appropriations BUD

FDA Funding. Budget Reconciliation. E-Labeling Prohibition in FY22 Ag-FDA Appropriations.

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

Pharmacy PHA

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.

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

Bills named: H.R. 2831 (117th), H.R. 2870 (117th), H.R. 2843 (117th), H.R. 2853 (117th)