Legis Daily

ADAPT Act

USA117th CongressS-1645| Senate 
| Updated: 5/13/2021
Mike Braun

Mike Braun

Republican Senator

Indiana

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act This bill authorizes the Food and Drug Administration (FDA) to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug. The FDA must process and review an application under this bill within 180 days of submission.
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Timeline

Bill from Previous Congress

S 116-658
ADAPT Act
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-658
    ADAPT Act


  • May 13, 2021
    Introduced in Senate


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

Health

Related Bills

  • S 117-2983: ADAPT for COVID Act
Drug safety, medical device, and laboratory regulationManufacturingMarketing and advertisingMedical researchPrescription drugs

ADAPT Act

USA117th CongressS-1645| Senate 
| Updated: 5/13/2021
Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act This bill authorizes the Food and Drug Administration (FDA) to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug. The FDA must process and review an application under this bill within 180 days of submission.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 116-658
ADAPT Act
May 13, 2021
Introduced in Senate
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 116-658
    ADAPT Act


  • May 13, 2021
    Introduced in Senate


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

Mike Braun

Republican Senator

Indiana

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • S 117-2983: ADAPT for COVID Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationManufacturingMarketing and advertisingMedical researchPrescription drugs