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. US-India Trade Discussions. TRIPS Waivers.

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

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

Pharmacy PHA

Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. 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. H.R.5388/S.2740: PREPARE Act. 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. Biosimilars Misinformation. FDA Inspections. FDA and Future Public Health Emergencies. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.

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

Bills named: H.R. 4711 (117th), H.R. 2883 (117th), S. 1425 (117th), H.R. 5388 (117th), S. 2740 (117th), H.R. 2831 (117th), H.R. 2870 (117th), H.R. 2843 (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. Restoring the America Invents Act (Leahy IPR Bill).

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

Bills named: H.R. 2884 (117th), S. 1428 (117th), S. 1435 (117th), H.R. 2873 (117th), H.R. 153 (117th), H.R. 2891 (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: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Natl Economic Council (NEC); Patent & Trademark Office (PTO); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Executive Office of the President (EOP); Food & Drug Administration (FDA); Commerce, Dept of (DOC); Office of Management & Budget (OMB); Federal Trade Commission (FTC)

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

Budget/Appropriations BUD

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

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