# 119-s-3081: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

119-s-3081, Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025, is a 119th Congress bill sponsored by Sen. Cruz, Ted [R-TX] (R-TX); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-s-3081
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3081
- Congress: 119
- Title: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
- Status: introduced
- Introduced: 2025-10-30
- Sponsor: Sen. Cruz, Ted [R-TX] (R-TX)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## 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. - 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.

## Cosponsors (1)

- Sen. Lee, Mike [R-UT] (R-UT), 2025-10-30T00:00:00.000Z

## Provisions PRIA read

- Faster access to foreign-approved treatments: mixed, medium. 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 sa…
- Sponsor requirements and FDA fees: mixed, medium. 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 tre…

## Related bills

- 119-s-1071: National Defense Authorization Act for Fiscal Year 2026
- 119-s-524: Coast Guard Authorization Act of 2025
- 119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026
- 119-s-4668: Protect College Sports Act of 2026
- 119-s-2975: PIPELINE Safety Act of 2025
- 119-s-4280: SAFE Act

## Sources
- [119-s-3081 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3081)

## Related
- [119-s-1071: National Defense Authorization Act for Fiscal Year 2026](https://policyrisk.com/legislation/119-s-1071)
- [119-s-524: Coast Guard Authorization Act of 2025](https://policyrisk.com/legislation/119-s-524)
- [119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3923)
- [119-s-4668: Protect College Sports Act of 2026](https://policyrisk.com/legislation/119-s-4668)
- [119-s-2975: PIPELINE Safety Act of 2025](https://policyrisk.com/legislation/119-s-2975)
- [119-s-4280: SAFE Act](https://policyrisk.com/legislation/119-s-4280)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3081 (as of 2026-04-21).