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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2026 · third_quarter · Q3
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
Source: Senate LDA
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Lower Costs, More Transparency Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Lower Costs, More Transparency Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Lower Costs, More Transparency Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Lower Costs, More Transparency Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Biosimilar Red Tape Elimination Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Biosimilar Red Tape Elimination Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Biosimilar Red Tape Elimination Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Biosimilar Red Tape Elimination Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Drug Price Transparency in Medicaid Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Block, Report, and Suspend Suspicious Shipments Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Lower Costs, More Transparency Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Ensuring Timely Access to Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Expanding Access to Low-Cost Generics Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Prescription Pricing for the People Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Pharmacy Benefit Manager Transparency Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Pharmacy Benefit Manager Reform Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Preserve Access to Affordable Generics and Biosimilars Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Affordable Prescriptions for Patients Act of 2023
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
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.
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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.
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Coastal Fellowships Act
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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). 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
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
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).
Protecting Consumer Access to Generic Drugs Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Protecting Consumer Access to Generic Drugs Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Protecting Consumer Access to Generic Drugs Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Protecting Consumer Access to Generic Drugs Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Protecting Consumer Access to Generic Drugs Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Speeding Therapy Access Today Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Speeding Therapy Access Today Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Speeding Therapy Access Today Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
Speeding Therapy Access Today Act of 2021
Client: TEVA PHARMACEUTICALS USA INC · Firm: TEVA PHARMACEUTICALS USA, INC.
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2026 · second_quarter · Q2
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2026 · first_quarter · Q1
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2025 · fourth_quarter · Q4
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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2025 · third_quarter · Q3
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).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2025 · second_quarter · 2A
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).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2025 · second_quarter · Q2
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).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2025 · first_quarter · Q1
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).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2024 · fourth_quarter · Q4
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).
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2024 · third_quarter · Q3
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).
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2024 · second_quarter · Q2
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 via TEVA PHARMACEUTICALS USA, INC.
2024 · first_quarter · Q1
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 via TEVA PHARMACEUTICALS USA, INC.
2023 · fourth_quarter · Q4
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).
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2023 · third_quarter · Q3
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). 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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2023 · second_quarter · Q2
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). 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.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2023 · first_quarter · Q1
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).
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2022 · third_quarter · 3A
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2022 · fourth_quarter · Q4
Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2022 · third_quarter · Q3
H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2022 · second_quarter · Q2
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2022 · first_quarter · Q1
S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · fourth_quarter · Q4
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · second_quarter · 2A
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. H.R.3, the" Elijah E. Cummings Lower Drug Costs Now Act." H.R.19, the "Lower Costs, More Cures Act of 2021." H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act." H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). S. 1462, the Simplifying the Generic Drug Application Process Act, and S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · third_quarter · 3A
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Drug pricing proposals in Congress and from the Executive Branch including HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 8479, The Essential Medicines Strategic Stockpile Act of 2020. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · third_quarter · Q3
Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Drug pricing proposals in Congress and from the Executive Branch including HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 8479, The Essential Medicines Strategic Stockpile Act of 2020. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · second_quarter · Q2
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. H.R., the" Elijah E. Cummings Lower Drug Costs Now Act." H.R.19, the "Lower Costs, More Cures Act of 2021." H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act." H.R. 2843, the "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. H.R. 2853, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). S. 1462, the Simplifying the Generic Drug Application Process Act, and S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2021 · first_quarter · Q1
Legislation and proposals related to the COVID-19 crisis. Drug pricing proposals in Congress and from the Executive Branch. Proposals designed to increase utilization of biosimilar medicines. Proposals to abrogate 180-day exclusivity for certain generic medicines. Proposals to change pharmaceutical patent laws. Proposals to restrict settlements of pharmaceutical patent disputes. Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines. S.164, Advancing Education on Biosimilars Act of 2021. S. 415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). Nomination of the HHS Secretary. Proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic.
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2020 · fourth_quarter · Q4
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2020 · third_quarter · Q3
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2020 · second_quarter · Q2
Foreign export restrictions pertaining to India and Italy
Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2020 · first_quarter · Q1
Foreign export restrictions pertaining to India and Italy
Coronavirus Aid, Relief & Economic Stability Act (CARES Act) and other legislative proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; and Administration review of drug pricing policies.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), White House Office
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2019 · fourth_quarter · Q4
US-Mexico-Canada Agreement (issues relating to IP Chapter)
HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; and Administration review of drug pricing policies.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2019 · second_quarter · 2A
US-Mexico-Canada Agreement (issues relating to IP Chapter)
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895, Lower Health Care Costs Act; and Administration review of drug pricing policies.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2019 · third_quarter · Q3
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act;and Administration review of drug pricing policies.
US-Mexico-Canada Agreement (issues relating to IP Chapter)
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2019 · second_quarter · Q2
US-Mexico-Canada Agreement (issues relating to IP Chapter)
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895, Lower Health Care Costs Act; and Administration review of drug pricing policies.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
TEVA PHARMACEUTICALS USA INC via TEVA PHARMACEUTICALS USA, INC.
2019 · first_quarter · 1A
S.340/HR 965-Creating & Restoring Equal Access to Equivalent Samples Act ("Creates Act"); HR 985-Fast Generics Act; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; and Administration rveview of drug pricing policies.
US-Mexico-Canada Agreement (issues relating to IP Chapter)
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office