ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Pharmacy PHA

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. 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. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. 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. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act 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. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. 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: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Natl Economic Council (NEC); SENATE; Commerce, Dept of (DOC); Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 5668 (116th), S. 102 (116th), H.R. 6201 (116th), S. 3092 (116th), S. 64 (116th), S. 659 (116th), H.R. 748 (116th), H.R. 2214 (116th), H.R. 4597 (116th), S. 3478 (116th), S. 1895 (116th), H.R. 4913 (116th), H.R. 3 (116th), H.R. 4398 (116th), S. 2543 (116th), H.R. 1506 (116th), S. 3538 (116th), H.R. 5982 (116th), H.R. 4244 (116th), S. 340 (116th), H.R. 4793 (116th), H.R. 4629 (116th), S. 2723 (116th), S. 3548 (116th), S. 3537 (116th), H.R. 465 (116th), H.R. 938 (116th), S. 1140 (116th), H.R. 965 (116th), S. 1416 (116th), H.R. 4455 (116th), S. 3384 (116th)

Taxation/Internal Revenue Code TAX

User Fee Programs.

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

Trade (domestic/foreign) TRD

General Trade Issues. Biologic Exclusivity. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. S. ___Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. H.R.___LOSS Act. Air Transport of Pharmaceuticals. 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. U.S.-China Phase 1 Trade Deal. Secretary Azar Importation Plan.

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

Bills named: H.R. 6049 (116th), S. 3343 (116th)

Copyright/Patent/Trademark CPT

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

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

Bills named: S. 1209 (116th), H.R. 3812 (116th), H.R. 3666 (116th), S. 1416 (116th), H.R. 3199 (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: Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Commerce, Dept of (DOC); Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; U.S. Trade Representative (USTR)

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

Budget/Appropriations BUD

FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. Section 605 of H.R.1865: Further Consolidated Appropriations Act, 2020. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.

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

Bills named: H.R. 1865 (116th)