ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Copyright/Patent/Trademark CPT

Patent Settlements. Patent Abuse. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act.

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

Budget/Appropriations BUD

FDA Funding. Budget Reconciliation.

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

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-UK Trade Agreement. US-India Trade Discussions. US-European Trade Discussions. US-China Trade Discussions. TRIPS Waivers.

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

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. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Shared Savings Program. Most Favored Nation Interim Final Rule.

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

Pharmacy PHA

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 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. S.917: Short on Competition Act. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Buy American Proposals. Issues Related to COVID-19. Secretary Azar Importation Plan.

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

Bills named: S. 917 (117th)