Legis Daily

ADAPT Act

USA116th CongressS-658| Senate 
| Updated: 3/5/2019
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
Mar 5, 2019
Introduced in Senate
Mar 5, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 8, 2020

Latest Companion Bill Action

HR 116-8183
Introduced in House
  • March 5, 2019
    Introduced in Senate


  • March 5, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 8, 2020

    Latest Companion Bill Action

    HR 116-8183
    Introduced in House

Health

Drug safety, medical device, and laboratory regulationManufacturingMarketing and advertisingMedical researchPrescription drugs

ADAPT Act

USA116th CongressS-658| Senate 
| Updated: 3/5/2019
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
Mar 5, 2019
Introduced in Senate
Mar 5, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 8, 2020

Latest Companion Bill Action

HR 116-8183
Introduced in House
  • March 5, 2019
    Introduced in Senate


  • March 5, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 8, 2020

    Latest Companion Bill Action

    HR 116-8183
    Introduced in House
Mike Braun

Mike Braun

Republican Senator

Indiana

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationManufacturingMarketing and advertisingMedical researchPrescription drugs