ASSOCIATION FOR ACCESSIBLE MEDICINES for ASSOCIATION FOR ACCESSIBLE MEDICINES

Taxation/Internal Revenue Code TAX

User Fee Programs.

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

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); Food & Drug Administration (FDA); Commerce, Dept of (DOC); SENATE; Natl Economic Council (NEC); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS)

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

Trade (domestic/foreign) TRD

General Trade Issues. Trans-Pacific Partnership (TPP). Biologic Exclusivity. Pharmaceutical Exclusivity. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. U.S.-India Trade Discussions. U.S.-European Trade Negotiations. U.S.-China Trade Negotiations. Secretary Azar Importation Plan.

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

Copyright/Patent/Trademark CPT

Inter Partes Review (IPR) Process. Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. Section 101 of the Patent Act. Patent Examination and Quality Improvement Act (Bill number not yet assigned). 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: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Commerce, Dept of (DOC); Natl Economic Council (NEC); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); SENATE

Bills named: S. 1209 (116th), S. 1416 (116th), H.R. 3666 (116th), H.R. 3812 (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. Medicare Shared Savings Program. S.1895: Lower Health Care Costs Act.

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

Bills named: S. 1895 (116th)

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. H.R.5381: International Pharmaceutical Transparency Act of 2019. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments 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. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. FDA Citizen Petitions. H.R.2387: STOP GAMES Act of 2019. 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. S.475: RxCAP Act of 2019. 180-Day Exclusivity. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. 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.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs 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. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. S.1805: Better Tools for Healthy Living 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).

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

Bills named: S. 1140 (116th), H.R. 1506 (116th), H.R. 4629 (116th), S. 1416 (116th), H.R. 5381 (116th), H.R. 4913 (116th), H.R. 465 (116th), H.R. 965 (116th), S. 2543 (116th), S. 659 (116th), S. 3092 (116th), H.R. 1499 (116th), H.R. 938 (116th), S. 475 (116th), H.R. 4398 (116th), H.R. 3 (116th), S. 1805 (116th), S. 1169 (116th), H.R. 2455 (116th), H.R. 4597 (116th), S. 102 (116th), H.R. 2376 (116th), S. 64 (116th), H.R. 4455 (116th), S. 1895 (116th), H.R. 2387 (116th), S. 340 (116th)