Skip to main content
HR 3532 118th Congress House Health Congressional oversight Drug safety, medical device, and laboratory regulation

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

Introduced: May 18, 2023 Introduced by: Roy, Chip Republican · Texas See on congress.gov
Sign in to write a letter Sign in to watch
This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 19, 2023
Referred to the Subcommittee on Health.
May 18, 2023
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
May 18, 2023
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023

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.

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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.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

What's happening now May 19, 2023

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • S 1712 Related bill Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3532: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023. 118th Congress. Open America. https://openamerica.io/bill/118-HR-3532/
MLA
"H.R. 3532: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-3532/.
Bluebook (legal)
H.R. 3532, 118th Cong. (2026), https://openamerica.io/bill/118-HR-3532/.
Markdown link
[H.R. 3532: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2023](https://openamerica.io/bill/118-HR-3532/)
Report a problem