Striking and Locked Out Workers Healthcare Protection Act
In Committee
Introduced:Oct 24, 2025
Primary Sponsor
Chip Roy
Representative
Republican
TX-21
Cosponsors
0
Quick Stats
Policy Area
Health
Summary
This bill aims to streamline the approval process for certain drugs, biological products, and medical devices that are already approved in other countries but not yet approved by the U.S. Food and Drug Administration (FDA). If a product meets certain criteria, it could potentially be approved for sale in the U.S. through a faster 'reciprocal' process, helping to address unmet medical needs more quickly.
Latest Action
Referred to the Subcommittee on Health.
AI Summary
Plain-English explanation of this bill
This bill aims to streamline the approval process for certain drugs, biological products, and medical devices that are already approved in other countries but not yet approved by the U.S. Food and Drug Administration (FDA). If a product meets certain criteria, it could potentially be approved for sale in the U.S. through a faster 'reciprocal' process, helping to address unmet medical needs more quickly.
Last updated: 12/29/2025
Official Summary
Congressional Research Service summary
<p><b>Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of </b><b>2023</b></p> <p>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. </p> <p>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has been approved in one of the specified countries, (2) neither the FDA nor any of the specified countries have withdrawn approval for the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.</p> <p>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.</p> <p>The FDA must issue a decision on whether to grant a request for reciprocal marketing approval within 30 days of receiving the request. </p> <p>Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.</p>
Key Points
Main provisions of the bill
Establishes a reciprocal marketing approval process for drugs, biologics, and medical devices approved in other countries but not yet approved by the FDA
Requires the product's sponsor to demonstrate the product is safe, effective, and addresses an unmet medical need in the U.S.
The FDA must decide on a reciprocal approval request within 30 days
Congress can pass a joint resolution to grant reciprocal approval if the FDA declines
The FDA can still decline approval if it determines the product is not safe or effective
How This Impacts Americans
Potential effects on citizens and communities
This bill could provide faster access to certain medical products for patients facing unmet needs, but there are concerns about maintaining safety and efficacy standards. It could particularly benefit individuals who need treatments not yet approved in the U.S. but available in other countries.
Policy Areas
Primary Policy Area
Health
Related Subjects
Congressional oversight
Drug safety, medical device, and laboratory regulation
Scope & Jurisdiction
Jurisdiction Level
federal
Congressional Session
119th Congress
Citation Reference
3532, 119th Congress (2025). "Striking and Locked Out Workers Healthcare Protection Act". Source: Voter's Right Platform. https://votersright.org/bills/118-hr-3532
