ADAPT Act
Summary
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.
Bill status
in committee
1 of 4 stages cleared
Introduction
May 2021
Committee Review
Floor Vote
President
Introduced May 13, 2021
Last action May 13, 2021
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
May 13, 2021
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
May 13, 2021
Introduced
Introduced in Senate
upper
1 primary · 0 co-sponsors
Sponsors
Role
Legislator
Party
State
District
P
Mike Braun
RRepublican
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