Legis Daily

ADAPT 2.0 Act

USA118th CongressS-1132| Senate 
| Updated: 3/30/2023
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (1)
Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues. If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements. The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials. The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.
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Timeline

Bill from Previous Congress

S 116-658
ADAPT Act

Bill from Previous Congress

S 117-3576
ADAPT 2.0 Act

Bill from Previous Congress

S 117-1645
ADAPT Act
Mar 30, 2023
Introduced in Senate
Mar 30, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 17, 2024

Latest Companion Bill Action

HR 118-9138
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-658
    ADAPT Act


  • Bill from Previous Congress

    S 117-3576
    ADAPT 2.0 Act


  • Bill from Previous Congress

    S 117-1645
    ADAPT Act


  • March 30, 2023
    Introduced in Senate


  • March 30, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 17, 2024

    Latest Companion Bill Action

    HR 118-9138
    Referred to the Subcommittee on Health.

Health

ADAPT 2.0 Act

USA118th CongressS-1132| Senate 
| Updated: 3/30/2023
Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues. If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements. The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials. The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.
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

Bill from Previous Congress

S 117-3576
ADAPT 2.0 Act

Bill from Previous Congress

S 117-1645
ADAPT Act
Mar 30, 2023
Introduced in Senate
Mar 30, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 17, 2024

Latest Companion Bill Action

HR 118-9138
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    S 116-658
    ADAPT Act


  • Bill from Previous Congress

    S 117-3576
    ADAPT 2.0 Act


  • Bill from Previous Congress

    S 117-1645
    ADAPT Act


  • March 30, 2023
    Introduced in Senate


  • March 30, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • December 17, 2024

    Latest Companion Bill Action

    HR 118-9138
    Referred to the Subcommittee on Health.
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (1)
Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted