American Made Pharmaceuticals Act of 2023

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines Lower Costs, More Transparency Act (H.R. 5378) H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act of 2023 H.R.1352: Increasing Access to Biosimilars Act of 2023 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Senate Finance Committee drug shortage legislation Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to DEA Quota Issues related to drug supply chain

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 476, the Maintaining Investments in New Innovation Act. S. 3131/ H.R. 5539, the ORPHAN Cures Act. H.R. 5547, the Maintaining Investments in New Innovation Act. No bill number. Discussed implementation of prescription drug provisions of Inflation Reduction Act. S. 150, Affordable Prescriptions for Patients Act of 2023. H.R. 6986, To address patent thickets. H.R. 9070, the Affordable Prescriptions for Patients Act. H.R. 1717, the Interagency Patent Coordination and Improvement Act of 2023. H.R. 5429, the Medication Affordability and Patent Integrity Act. S. 2780, the Medication Affordability and Patent Integrity Act. S. 4878, the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act. No bill number. Discussed the Medicare Drug Price Negotiation Program Draft Guidance. No bill number. Discussed Medicare Prescription Payment Plan. No bill number. Discussed out-of-pocket caps for prescription drugs. No bill number. Discussed pharmacy benefit manager reforms. No bill number. Discussed Medicare negotiated drug prices. No bill number. Discussed the low-income subsidy Extra Help program. No bill number. Discussed Medicare Part D open enrollment. S. 2973, the Modernizing and Ensuring PBM Accountability Act. S. 142, the Preserve Access to Affordable Generics and Biosimilars Act. S. 4845, the Prescription Drug Affordability and Access Act. S.3311, the American Made Pharmaceuticals Act of 2023.

Client expense: $4,820,000 · Firm income: Not reported

Domestic Manufacturing Medicare implications on biosimilars, Part D reform Drug Rebate Reform Appropriations pertaining to American Made preference HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 FDA foreign inspections ASPR/BARDA funding and policy Interchangeability of biosimilars legislation

Client expense: $45,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Domestic Manufacturing Medicare implications on biosimilars, Part D reform Drug Rebate Reform Appropriations pertaining to American Made preference HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 FDA foreign inspections ASPR/BARDA funding and policy Interchangeability of biosimilars legislation

Client expense: $87,500 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Domestic Manufacturing Medicare implications on biosimilars, Part D reform Drug Rebate Reform Appropriations pertaining to American Made preference HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 FDA foreign inspections ASPR/BARDA funding and policy Interchangeability of biosimilars legislation

Client expense: $30,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Domestic Manufacturing Medicare implications on biosimilars, Part D reform Drug Rebate Reform Appropriations pertaining to American Made preference HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 FDA foreign inspections ASPR/BARDA funding and policy Interchangeability of biosimilars legislation

Client expense: $87,500 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Domestic Manufacturing Medicare implications on biosimilars, Part D reform Drug Rebate Reform Appropriations pertaining to American Made preference HHS Supply Chain Readiness HHS Biosimilar Uptake American-Made, Security of the American Pharmaceutical and Medical Supply Chain 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 FDA foreign inspections ASPR/BARDA funding and policy Interchangeability of biosimilars legislation

Client expense: $175,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

S. 3311 - American Made Pharmaceuticals Act of 2023 - Support for policies that encourage keeping the different elements of the prescription drug supply chain in the country to support better access to lifesaving medications and expand the number of quality jobs in the United States. Issues related to drug shortages in the United States and the role biosimilars can play. Issues related to cancer care and developing both biosimilar and novel treatments to fight disease. Issues related to advancing biosimilars in the health care market place to increase access and efficacy of life saving drugs. Support for encouraging the development, manufacturing and distribution of American-made biosimilars and other related products.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE