COLMAN RAGAN

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), and Lower Costs, More Transparency Act (H.R. 5378). Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S.142), Affordable Prescriptions for Patients Act (S.150). Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). S. 1067, Ensuring Timely Access to Generics Act. S. 1339, Pharmacy Benefit Manager Reform Act. S. 1114, Expanding Access to Low-Cost Generics Act of 2023. S. 1552, A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. S. 1543, A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services. Biosimilar Red Tape Elimination Act (S. 2305). Appeal of a decision regarding the CTPAT Program (DHS).

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), and Lower Costs, More Transparency Act (H.R. 5378). 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). Proposals related to drug shortages. Reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). S. 1067, Ensuring Timely Access to Generics Act. S. 1339, Pharmacy Benefit Manager Reform Act. S. 1114, Expanding Access to Low-Cost Generics Act of 2023. S. 1552, A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable. S. 1543, A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services. Biosimilar Red Tape Elimination Act (S. 2305). Appeal of a decision regarding the CTPAT Program (DHS).

TEVA PHARMACEUTICALS USA INC

TEVA PHARMACEUTICALS USA INC

TEVA PHARMACEUTICALS USA INC