Legis Daily

Promising Pathway Act

USA118th CongressHR-4408| House 
| Updated: 7/7/2023
Mike Gallagher

Mike Gallagher

Republican Representative

Wisconsin

Cosponsors (10)
Mike Garcia (Republican)Eric Swalwell (Democratic)Joe Wilson (Republican)Dean Phillips (Democratic)Bruce Westerman (Republican)Anthony D'Esposito (Republican)Mike Quigley (Democratic)Lois Frankel (Democratic)Brian K. Fitzpatrick (Republican)Josh Gottheimer (Democratic)

Health Subcommittee, Energy and Commerce 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.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 116-7269
Promising Pathway Act

Bill from Previous Congress

HR 117-3761
Promising Pathway Act
Jun 30, 2023
Introduced in House
Jun 30, 2023
Referred to the House Committee on Energy and Commerce.
Jul 7, 2023
Referred to the Subcommittee on Health.
May 23, 2024

Latest Companion Bill Action

S 118-4426
Introduced in Senate
  • Bill from Previous Congress

    HR 116-7269
    Promising Pathway Act


  • Bill from Previous Congress

    HR 117-3761
    Promising Pathway Act


  • June 30, 2023
    Introduced in House


  • June 30, 2023
    Referred to the House Committee on Energy and Commerce.


  • July 7, 2023
    Referred to the Subcommittee on Health.


  • May 23, 2024

    Latest Companion Bill Action

    S 118-4426
    Introduced in Senate

Health

Related Bills

  • S 118-1906: 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 CongressHR-4408| House 
| Updated: 7/7/2023
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

HR 116-7269
Promising Pathway Act

Bill from Previous Congress

HR 117-3761
Promising Pathway Act
Jun 30, 2023
Introduced in House
Jun 30, 2023
Referred to the House Committee on Energy and Commerce.
Jul 7, 2023
Referred to the Subcommittee on Health.
May 23, 2024

Latest Companion Bill Action

S 118-4426
Introduced in Senate
  • Bill from Previous Congress

    HR 116-7269
    Promising Pathway Act


  • Bill from Previous Congress

    HR 117-3761
    Promising Pathway Act


  • June 30, 2023
    Introduced in House


  • June 30, 2023
    Referred to the House Committee on Energy and Commerce.


  • July 7, 2023
    Referred to the Subcommittee on Health.


  • May 23, 2024

    Latest Companion Bill Action

    S 118-4426
    Introduced in Senate
Mike Gallagher

Mike Gallagher

Republican Representative

Wisconsin

Cosponsors (10)
Mike Garcia (Republican)Eric Swalwell (Democratic)Joe Wilson (Republican)Dean Phillips (Democratic)Bruce Westerman (Republican)Anthony D'Esposito (Republican)Mike Quigley (Democratic)Lois Frankel (Democratic)Brian K. Fitzpatrick (Republican)Josh Gottheimer (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 118-1906: 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