S. 3081: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025
A Senate bill (S.) in the 119th U.S. Congress.
Overview
| Congress | 119th U.S. Congress (2025–2026) |
|---|---|
| Type | Senate bill (S.) |
| Originating chamber | Senate |
| Introduced | 2025-10-30 |
| Sponsor | Sen. Cruz, Ted [R-TX] |
| Policy area | Health |
| Cosponsors | 1 |
| Latest action | 2025-10-30 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
| Last updated | 2026-04-03 |
Summary
Official summary (Introduced in Senate, 2025-10-30):
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approved in one of the countries specified in the bill, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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.
Cosponsors (1)
| Name | Party / state |
|---|---|
| Mike Lee | R UT (original cosponsor) 2025-10-30 |
Full text & official record
The official bill text, section-by-section summary, amendments, committee reports, and the complete legislative timeline for S. 3081 are published by Congress on congress.gov.
View S. 3081 on congress.gov →
Frequently asked questions
What is S. 3081?
S. 3081 is a Senate bill (S.) introduced in the 119th U.S. Congress, originating in the Senate. Official title: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025.
Where can I read the full bill text?
The full text, cosponsors, amendments, and legislative status for S. 3081 are available on congress.gov.
Bill data: congress.gov API (official congressional records).