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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.
- Introduced
- Committee
- Passed Senate
- Passed House
- To President
- Became law
Summary
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.
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.
Summary by the Congressional Research Service, Library of Congress.
Actions
- Oct 30, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Oct 30, 2025 Introduced in Senate
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