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Promising Pathway Act

USA118th CongressS-1906| Senate 
| Updated: 6/8/2023
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (19)
Jeanne Shaheen (Democratic)Kirsten E. Gillibrand (Democratic)Alex Padilla (Democratic)Cynthia M. Lummis (Republican)Eric Schmitt (Republican)J. D. Vance (Republican)Lindsey Graham (Republican)Roger F. Wicker (Republican)Joe Manchin (Independent)Kevin Cramer (Republican)Jon Tester (Democratic)John Kennedy (Republican)John Fetterman (Democratic)Peter Welch (Democratic)Raphael G. Warnock (Democratic)Pete Ricketts (Republican)Steve Daines (Republican)Lisa Murkowski (Republican)Shelley Moore Capito (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Promising Pathway Act This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions. Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects. Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.
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Timeline

Bill from Previous Congress

S 116-3872
Promising Pathway Act

Bill from Previous Congress

S 117-1644
Promising Pathway Act
Jun 8, 2023
Introduced in Senate
Jun 8, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 4, 2024

Latest Companion Bill Action

HR 118-9938
Introduced in House
  • Bill from Previous Congress

    S 116-3872
    Promising Pathway Act


  • Bill from Previous Congress

    S 117-1644
    Promising Pathway Act


  • June 8, 2023
    Introduced in Senate


  • June 8, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 4, 2024

    Latest Companion Bill Action

    HR 118-9938
    Introduced in House

Health

Related Bills

  • HR 118-4408: Promising Pathway Act
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth information and medical recordsPrescription drugs

Promising Pathway Act

USA118th CongressS-1906| Senate 
| Updated: 6/8/2023
Promising Pathway Act This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions. Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects. Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 116-3872
Promising Pathway Act

Bill from Previous Congress

S 117-1644
Promising Pathway Act
Jun 8, 2023
Introduced in Senate
Jun 8, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 4, 2024

Latest Companion Bill Action

HR 118-9938
Introduced in House
  • Bill from Previous Congress

    S 116-3872
    Promising Pathway Act


  • Bill from Previous Congress

    S 117-1644
    Promising Pathway Act


  • June 8, 2023
    Introduced in Senate


  • June 8, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 4, 2024

    Latest Companion Bill Action

    HR 118-9938
    Introduced in House
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (19)
Jeanne Shaheen (Democratic)Kirsten E. Gillibrand (Democratic)Alex Padilla (Democratic)Cynthia M. Lummis (Republican)Eric Schmitt (Republican)J. D. Vance (Republican)Lindsey Graham (Republican)Roger F. Wicker (Republican)Joe Manchin (Independent)Kevin Cramer (Republican)Jon Tester (Democratic)John Kennedy (Republican)John Fetterman (Democratic)Peter Welch (Democratic)Raphael G. Warnock (Democratic)Pete Ricketts (Republican)Steve Daines (Republican)Lisa Murkowski (Republican)Shelley Moore Capito (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-4408: Promising Pathway Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth information and medical recordsPrescription drugs