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HR1632119th CongressWALLET

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

Sponsored By: Representative Roy, Chip [R-TX-21]

Introduced

Summary

Creates a pathway for U.S. approval of drugs, biologics, and devices already lawfully marketed abroad. It would set eligibility rules, require sponsors to submit translated foreign dossiers, impose a 30-day decision clock, and allow congressional disapproval.

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  • Patients and families: Could speed access to treatments and devices that address a public health or unmet medical need and are not currently available in the U.S.
  • Sponsors and manufacturers: Would file a request with English translations of foreign dossiers and pay applicable fees as if filing an application. The agency would approve or deny within 30 days and could require postmarket studies or risk-mitigation plans.
  • FDA and Congress: The agency may deny approvals for safety or effectiveness and must report denials monthly to congressional committees. Congress could block an approval through a joint resolution.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Faster U.S. access to foreign-approved treatments

If enacted, the bill would set up a fast track for some medicines and devices already sold abroad. A company could ask the FDA to recognize a drug, biologic, or device that is lawfully marketed in countries named in law or in the United Kingdom. It would only apply if the product is not already cleared in the United States, has not been pulled abroad for safety or effectiveness, is not a banned device, and meets a public health or unmet medical need here. The FDA would have 30 days to grant or deny; it could require extra safety studies or risk controls, and labeling would be set during that window. The order would take effect unless Congress overturns it under fast‑track rules, and the FDA would report denials to Congress.

Sponsors & CoSponsors

Sponsor

Roy, Chip [R-TX-21]

TX • R

Cosponsors

  • Rep. Harris, Andy [R-MD-1]

    MD • R

    Sponsored 2/27/2025

Roll Call Votes

No roll call votes available for this bill.

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