118th Congress Health
S. 1132: ADAPT 2.0 Act
Introduced
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.
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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.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Rand Paul R-KYOriginal
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Other bills by Mike Braun
History
- Introduced in the Senate by Mike Braun.
Show the full action history (2 actions)
- Introduced in Senate
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.