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FREED of Opioids Act

USA117th CongressS-1634| Senate 
| Updated: 5/13/2021
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 and vote on whether to permit the use of this methodology in drug clinical trials.
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Timeline
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 13, 2021
    Introduced in Senate


  • May 13, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Advisory bodiesDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFood and Drug Administration (FDA)Government studies and investigationsMedical research

FREED of Opioids Act

USA117th CongressS-1634| Senate 
| Updated: 5/13/2021
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 and vote on whether to permit the use of this methodology in drug clinical trials.
View Full Text

Suggested Questions

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

Timeline
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • May 13, 2021
    Introduced in Senate


  • May 13, 2021
    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

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Advisory bodiesDepartment of Health and Human ServicesDrug, alcohol, tobacco useDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesFood and Drug Administration (FDA)Government studies and investigationsMedical research