TEVA PHARMACEUTICALS USA, INC. for TEVA PHARMACEUTICALS USA INC

Health Issues HCR

Use of Section viii statements in pharmaceutical labeling. FDAs approval of over-the-counter naloxone nasal spray. 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).

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

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).

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

Bills named: S.J.Res. 37 (119th)