TEVA PHARMACEUTICALS USA, INC. for TEVA PHARMACEUTICALS USA INC

Health Issues HCR

Use of Section viii statements in pharmaceutical labeling. Changes to Hatch-Waxmans 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and legislation to reform pharmacy benefit managers. Patent reform legislation. Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). Proposals related to biosimilar drugs. Proposals related to changes in prescription drug labeling. Proposals related to supply chain security and manufacturing. Proposals related to mental health parity, step therapy and utilization management.

Foreign entity interest: Teva Pharmaceutical Industries, Ltd., identified on Registration (LD-1) as the indirect parent of Teva Pharmaceuticals USA Inc., has an interest in the issues listed.

Contacted: Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Homeland Security, Dept of (DHS); Food & Drug Administration (FDA); SENATE; Executive Office of the President (EOP)

Tariff (miscellaneous tariff bills) TAR

A joint resolution terminating the national emergency declared to impose duties on articles imported from Canada (S.J.Res.37). Tariff Transparency Act of 2025 (S.959) and Trump Tariff Transparency Act (H.R.6888).

Foreign entity interest: Teva Pharmaceutical Industries, Ltd., identified on Registration (LD-1), as the indirect parent of Teva Pharmaceuticals USA, Inc., has an interest in the issues listed.

Contacted: Food & Drug Administration (FDA); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; U.S. Trade Representative (USTR); Commerce, Dept of (DOC)

Bills named: S.J.Res. 37 (119th), H.R. 6888 (119th), S. 959 (119th)