What does RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS, BIOLOGICAL of Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025 do?

This section amends the Federal Food, Drug, and Cosmetic Act to establish a process for reciprocal marketing approval of drugs, biological products, and devices. A 'covered product' is eligible for reciprocal marketing approval if it is authorized for lawful marketing in certain countries or the United Kingdom and meets specific criteria related to safety, effectiveness, and unmet medical need. The Secretary may decline to grant reciprocal marketing approval if the product is deemed unsafe or ineffective. The Secretary is required to issue an order granting or declining approval within 30 days of receiving a request. Congress can disapprove the Secretary’s decision to deny reciprocal marketing approval through a joint resolution. The Secretary must conduct an outreach campaign to encourage eligible sponsors to request reciprocal marketing approval.

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Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

Q: What does Preamble of Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025 do?

This bill aims to amend the Federal Food, Drug, and Cosmetic Act. The proposed amendment focuses on reciprocal marketing approval for certain drugs, biological products, and devices. These products must already be authorized for lawful marketing in foreign countries.

Q: What does SHORT TITLE. of Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025 do?

This bill is formally titled the 'Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025'.

Last updated: 10/30/2025 · Introduced: 10/30/2025

Author: Ted Cruz (R-TX)

TL;DR (AI)

This bill establishes a process for the FDA to grant expedited marketing approval for drugs, biological products, and devices already authorized in certain foreign countries, including the United Kingdom.
The FDA Secretary must issue a decision on reciprocal marketing approval requests within 30 days, with Congress retaining the ability to disapprove denials.
The FDA is mandated to promote this reciprocal approval process through an outreach campaign to potential sponsors.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 1 more.

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