ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

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. S.4175: Pharmaceutical Supply Chain Defense and Enhancement Act. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.

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

Bills named: S. 4175 (116th)

Copyright/Patent/Trademark CPT

Patent Settlements. Patent Abuse. BPCIA Patent Dance. Inter Partes Review. Government patent use law in regards to Section 1498 of statute codified at 28 USC Section 1498(a). H.R.4850/S.659: Biologic Patent Transparency Act. H.R.3666: STRONGER Patents Act of 2019. S.4253: Second Look at Drug Patents Act of 2020.

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

Bills named: S. 4253 (116th), S. 659 (116th), H.R. 3666 (116th), H.R. 4850 (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. 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. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

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

Bills named: H.R. 6179 (116th), H.R. 4913 (116th), S. 1895 (116th)

Budget/Appropriations BUD

FDA Funding. S. Rept. 116-236: National Defense Authorization Act for Fiscal Year 2021. Public Law 115-141: Consolidated Appropriations Act of 2018.

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

Pharmacy PHA

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors 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. 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. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

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

Bills named: S. 659 (116th), S. 102 (116th), H.R. 6516 (116th), S. 3478 (116th), H.R. 4597 (116th), H.R. 6179 (116th), S. 1895 (116th), S. 4492 (116th), H.R. 3 (116th), S. 2543 (116th), H.R. 938 (116th), H.R. 4913 (116th), H.R. 4629 (116th), H.R. 465 (116th), S. 4134 (116th), H.R. 4455 (116th)