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 reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613). Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S.142), Affordable Prescriptions for Patients Act (S.150). Block, Report, and Suspend Suspicious Shipments Act (H.R. 501).

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

Bills named: H.R. 501 (118th), S. 142 (118th), S. 150 (118th), S. 113 (118th), S. 127 (118th), H.R. 1613 (118th)