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FREED of Opioids Act

USA118th CongressS-2737| Senate 
| Updated: 9/7/2023
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials. Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain. The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study, vote on whether to permit the use of this methodology in drug clinical trials, and review the appropriateness of labeling on approved opioid drugs in relation to this methodology.
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Timeline

Bill from Previous Congress

S 117-1634
FREED of Opioids Act
Sep 7, 2023
Introduced in Senate
Sep 7, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-1634
    FREED of Opioids Act


  • September 7, 2023
    Introduced in Senate


  • September 7, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 118-3393: SUPPORT for Patients and Communities Reauthorization Act

FREED of Opioids Act

USA118th CongressS-2737| Senate 
| Updated: 9/7/2023
FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials. Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain. The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study, vote on whether to permit the use of this methodology in drug clinical trials, and review the appropriateness of labeling on approved opioid drugs in relation to this methodology.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 117-1634
FREED of Opioids Act
Sep 7, 2023
Introduced in Senate
Sep 7, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-1634
    FREED of Opioids Act


  • September 7, 2023
    Introduced in Senate


  • September 7, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Joe Manchin

Joe Manchin

Independent Senator

West Virginia

Cosponsors (1)
Mike Braun (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 118-3393: SUPPORT for Patients and Communities Reauthorization Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted