ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Pharmacy PHA

Prescription Drug Costs. Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. Labeling of Generic Drugs and Biosimilars. Section 505(j)(10) Labeling [Legislation not yet introduced]. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. Incentivize Domestic Manufacturing. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. FDA Inspections. Energy & Commerce Factory Inspection Legislation. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. Shaheen-Cassidy Citizen Petition Legislation. 506I Marketing Status Updates. Buy American Proposals. Issues Related to COVID-19. Inflation Reduction Act (IRA) Implementation.

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

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. Rebates and Pharmacy Benefit Managers (PBMs). Medicare Price Negotiation. Medicare Advantage Proposed Rule. Inflation Reduction Act (IRA) Implementation.

Contacted: Office of Management & Budget (OMB); SENATE; Natl Economic Council (NEC); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS)

Copyright/Patent/Trademark CPT

Patent Settlements. Patent Abuse. Skinny Labeling. Inter Partes Review. Impact of IPR decisions on 30-month stay. IPR Amendments. Cornyn-Leahy IPR Proposals. Patent Quality. Enhancing Quality of Patents through the Patent Trial and Appeal Board (PTAB). Patent Listings in Orange Book. S.79: Interagency Patent Coordination and Improvement Act of 2023. S.113: Prescription Pricing for the People Act of 2023. S.142: Preserve Access to Affordable Generics and Biosimilars Act. S.148: Stop STALLING Act. S.150: Affordable Prescriptions for Patients Act of 2023.

Contacted: HOUSE OF REPRESENTATIVES; SENATE; Patent & Trademark Office (PTO); Natl Economic Council (NEC)

Bills named: S. 113 (118th), S. 150 (118th), S. 148 (118th), S. 79 (118th), S. 142 (118th)

Budget/Appropriations BUD

FDA Funding.

Contacted: SENATE; HOUSE OF REPRESENTATIVES

Trade (domestic/foreign) TRD

General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain Challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. U.S.-India Trade Discussions.

Contacted: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); SENATE; U.S. Trade Representative (USTR)