What does Preamble of FAIR ACT do?

This bill aims to accelerate patient access to innovative medicines and clinical trials for life-threatening diseases. It proposes establishing a reciprocal approval mechanism with trusted international regulatory authorities.

What does SHORT TITLE. of FAIR ACT do?

This bill is formally titled the Fast-tracking Approval for Innovative Rare disease therapies Act

What does FINDINGS. of FAIR ACT do?

This section outlines findings related to patient access to innovative medicines in the United States. It states that patients in the U.S. often experience delays in accessing medicines compared to patients in other nations. The regulatory process at the Food and Drug Administration is identified as a contributing factor to clinical trials moving abroad. The growth of clinical trial and biopharmaceutical development capacity in countries like China is noted as a potential threat to U.S. leadership. A reciprocal approval mechanism with international regulatory authorities is proposed as a means to accelerate patient access and maintain U.S. competitiveness.

What does RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS. of FAIR ACT do?

This section amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process for certain drugs. To be eligible, a product must be lawfully marketed in a foreign country by a 'trusted international regulatory authority' and intended for use in the diagnosis, treatment, or mitigation of an immediately life-threatening disease or condition. The Secretary must grant or decline reciprocal marketing approval within 30 days of receiving a request. During that 30-day period, the Secretary finalizes labeling and any necessary post-market studies. The Secretary can withdraw or suspend reciprocal marketing approval if new evidence demonstrates unreasonable risks or if the foreign regulatory authority rescinds its approval. The Secretary must submit a report to Congress within five years of enactment evaluating the program's effectiveness, approvals, impact on patient safety, and recommendations for continuation or modification.

What does RECIPROCAL ALLOWANCE OF CLINICAL INVESTIGATIONS AUTHORIZED BY of FAIR ACT do?

This section amends Chapter V of the Federal Food, Drug, and Cosmetic Act It allows manufacturers to seek reciprocal allowance for clinical trials Manufacturers must submit an application with authorization from a trusted international regulatory authority The Secretary must treat the application as meeting criteria for a new drug investigation The Secretary has 30 days to issue an order allowing or declining the reciprocal allowance

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FAIR ACT

Last updated: 3/17/2026 · Introduced: 3/17/2026

Author: Pete Sessions (R-TX)

TL;DR (AI)

The bill establishes a reciprocal marketing approval process for certain drugs that are lawfully marketed in foreign countries by trusted international regulatory authorities and intended for life-threatening diseases or conditions.
The bill allows manufacturers to seek reciprocal allowance for clinical trials authorized by trusted international regulatory authorities, streamlining the process for new drug investigations.
The Secretary of the Food and Drug Administration must submit a report to Congress within five years of enactment evaluating the effectiveness of the reciprocal marketing approval program and its impact on patient safety.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 3 more.

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