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Promising Pathway Act

USA117th CongressS-1644| Senate 
| Updated: 5/13/2021
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (6)
James E. Risch (Republican)Roger F. Wicker (Republican)John Boozman (Republican)Kevin Cramer (Republican)Susan M. Collins (Republican)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
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Timeline

Bill from Previous Congress

S 116-3872
Promising Pathway Act
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 9, 2021

Latest Companion Bill Action

HR 117-3761
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-3872
    Promising Pathway Act


  • May 13, 2021
    Introduced in Senate


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


  • June 9, 2021

    Latest Companion Bill Action

    HR 117-3761
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
  • HR 117-3761: Promising Pathway Act
Cardiovascular and respiratory healthCivil actions and liabilityCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careEmployee benefits and pensionsGovernment information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth care coverage and accessHealth information and medical recordsImmunology and vaccinationInfectious and parasitic diseasesLicensing and registrationsManufacturingMedical researchMedical tests and diagnostic methodsPrescription drugsScientific communication

Promising Pathway Act

USA117th CongressS-1644| Senate 
| Updated: 5/13/2021
Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
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
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 9, 2021

Latest Companion Bill Action

HR 117-3761
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-3872
    Promising Pathway Act


  • May 13, 2021
    Introduced in Senate


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


  • June 9, 2021

    Latest Companion Bill Action

    HR 117-3761
    Referred to the Subcommittee on Health.
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (6)
James E. Risch (Republican)Roger F. Wicker (Republican)John Boozman (Republican)Kevin Cramer (Republican)Susan M. Collins (Republican)Lisa Murkowski (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-8588: Fair Care Act of 2022
  • HR 117-3761: Promising Pathway Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Cardiovascular and respiratory healthCivil actions and liabilityCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyEmergency medical services and trauma careEmployee benefits and pensionsGovernment information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth care coverage and accessHealth information and medical recordsImmunology and vaccinationInfectious and parasitic diseasesLicensing and registrationsManufacturingMedical researchMedical tests and diagnostic methodsPrescription drugsScientific communication