119th Congress Health
H.R. 1632: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need for the product.
Specifically, in order to receive reciprocal approval, the bill requires the product's sponsor to demonstrate, among other things, that (1) the product has been approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.
The FDA may decline approval if it determines that the product is not safe or effective. The FDA may condition reciprocal approval on the conduct of postmarket studies.
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The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request.
Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.
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
- Andy Harris R-MD
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Other bills by Chip Roy
History
- Introduced in the House by Chip Roy.
Show the full action history (2 actions)
- Introduced in House
- Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.