S3081Referred to Committee

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-10-30
Introduced
1
Cosponsors
S
ⓘ
Type

Sponsor

Ted Cruz
Ted Cruz
Republican · TX · Senator
Votes with party: 33.1% (308 recorded votes)

Full profile: /officials/C001098

Source: Congress.gov · FEC

Cosponsors (1)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

2025-10-30

Source: Congress.gov

Committee Activity

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Plain-English 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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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