Criminal History Access Act of 2025

Senate Bill

S. 1712

119th Congress

Criminal History Access Act of 2025

In Committee

Introduced:Jul 23, 2025

Primary Sponsor

Ted Cruz

R - TX

Cosponsors

1

Quick Stats

Policy Area

Health

Summary

This bill aims to allow the sale of certain drugs, biologics, and medical devices in the United States that have been approved for use in other countries, even if they haven't been approved by the FDA. This is intended to provide faster access to treatments when there is an unmet medical need.

Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Introduced7/23/2025

StatusRead twice and referred to the Committee on the Judiciary.

ChamberSenate

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Vote Prediction

Criminal History Access Act of 2025

This bill aims to allow the sale of certain drugs, biologics, and medical devices in the United States that have been approved for use in other countries, even if they haven't been approved by the FDA. This is intended to provide faster access to treatments wh

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This bill aims to allow the sale of certain drugs, biologics, and medical devices in the United States that have been approved for use in other countries, even if they haven't been approved by the FDA. This is intended to provide faster access to treatments when there is an unmet medical need.

Bill Number: 1712
Introduced: 7/23/2025
Status: Read twice and referred to the Committee on the Judiciary.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: Criminal History Access Act of 2025
Bill Number: 1712
Sponsor: No sponsor
Status: Read twice and referred to the Committee on the Judiciary.
Introduced: 7/23/2025
Summary: This bill aims to allow the sale of certain drugs, biologics, and medical devices in the United States that have been approved for use in other countries, even if they haven't been approved by the FDA. This is intended to provide faster access to treatments when there is an unmet medical need.

Data from Congress.gov

AI Summary

Plain-English explanation of this bill

This bill aims to allow the sale of certain drugs, biologics, and medical devices in the United States that have been approved for use in other countries, even if they haven't been approved by the FDA. This is intended to provide faster access to treatments when there is an unmet medical need.

Last updated: 12/30/2025

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 process for 'reciprocal approval' of products approved in other countries, without needing full FDA approval
Requires the product sponsor to demonstrate the product is safe, effective, and meets an unmet medical need
The FDA can still decline approval if they determine the product is not safe or effective
Congress can override an FDA denial and grant reciprocal approval through a joint resolution
Aims to provide faster access to treatments when there is a public health or unmet medical need

How This Impacts Americans

Potential effects on citizens and communities

This bill would primarily affect patients in the United States who are seeking access to drugs, biologics, and medical devices that are available in other countries but not yet approved by the FDA. It could potentially provide quicker access to some treatments, but also raises concerns about safety and efficacy oversight. Various patient groups, healthcare providers, and the pharmaceutical industry would likely be impacted.

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

1712, 119th Congress (2025). "Criminal History Access Act of 2025". Source: Voter's Right Platform. https://votersright.org/bills/118-s-1712

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