Striking and Locked Out Workers Healthcare Protection Act

House Bill

H.R. 3532

119th Congress

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.

SponsorChip Roy (R-TX)

Introduced10/24/2025

StatusReferred to the House Committee on Education and Workforce.

ChamberHouse

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Vote Prediction

Striking and Locked Out Workers Healthcare Protection Act

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,

Community Breakdown

Pass

0%

Fail

0%

0 predictions

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.

Bill Number: 3532
Sponsor: Chip Roy (R-TX)
Introduced: 10/24/2025
Status: Referred to the House Committee on Education and Workforce.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: Striking and Locked Out Workers Healthcare Protection Act
Bill Number: 3532
Sponsor: Chip Roy (R-TX)
Status: Referred to the House Committee on Education and Workforce.
Introduced: 10/24/2025
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 sa

Data from Congress.gov

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

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.

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