Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
Sponsored By: Senator Ted Cruz
Introduced
Summary
This bill would create a new "reciprocal marketing approval" pathway so certain drugs, biological products, and devices lawfully marketed abroad can be treated as if they have U.S. approval or clearance. It aims to let sponsors request a fast, defined review when a product is already authorized in qualifying foreign countries, including the United Kingdom.
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- Patients and families: Eligible products that meet the bill's rules could reach U.S. patients sooner if the product is lawfully marketed abroad and meets an identified public health or unmet medical need.
- Sponsors and manufacturers: Sponsors would submit a request with English translations of foreign authorization dossiers and could get a decision within 30 days. Fees for these requests count as the existing application or premarket notification fees.
- FDA oversight and Congress: The Secretary could deny or impose postmarket studies, including REMS-type conditions, and must list denials monthly and report them to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. Congress could reverse a denial by enacting a joint resolution modeled on the administrative disapproval process.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 0 benefits, 0 costs, 2 mixed.
Faster access to foreign-approved treatments
If enacted, this would let certain drugs, biologics, and devices lawfully marketed abroad be treated as if FDA-approved after reciprocal approval. The FDA would have 30 days to grant or deny a reciprocal request and must finalize product labeling during that time. The FDA could deny approval for safety or effectiveness or require postmarket studies. Congress could override an FDA denial by passing a joint resolution.
Sponsor requirements and FDA fees
If enacted, sponsors could request reciprocal marketing approval for covered products authorized in listed foreign countries or the United Kingdom. Sponsors would need to submit required information, including English translations of each foreign dossier that authorized marketing. The FDA would treat reciprocal requests like comparable U.S. applications for user-fee purposes, so usual application fees would apply. The FDA would also be required to conduct outreach to encourage eligible sponsors to apply.
Sponsors & CoSponsors
Sponsor
Ted Cruz
TX • R
Cosponsors
Mike Lee
UT • R
Sponsored 10/30/2025
Roll Call Votes
No roll call votes available for this bill.
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