FAIR ACT
- Sponsor
- Rep. Sessions, Pete [R-TX-17]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Mar 17, 2026
Bottom line
The FAIR ACT seeks to expedite patient access to life-saving therapies and boost U.S. biomedical research competitiveness by leveraging approvals and clinical trial authorizations from established international regulatory bodies.
What it actually does
This bill, the "FAIR ACT," establishes a reciprocal marketing approval mechanism for certain drugs and biological products intended for immediately life-threatening diseases. It allows the FDA to deem a product approved if it has been authorized by a "trusted international regulatory authority" (e.g., EMA, Health Canada, UK MHRA) and meets other safety criteria. Additionally, it creates a reciprocal allowance for clinical investigations, treating trials authorized by these trusted foreign authorities as meeting FDA's investigational new drug (IND) criteria, aiming to accelerate clinical trial initiation in the U.S.
Proponents argue
Proponents argue that the bill will significantly reduce delays for U.S. patients in accessing innovative, life-saving medicines already approved in other trusted nations. They contend it will reverse the trend of clinical trials moving abroad, thereby preserving U.S. leadership in biomedical innovation and providing more opportunities for American patients to participate in cutting-edge research, especially for rare and immediately life-threatening conditions.
Opponents contend
Opponents might argue that this reciprocal approval mechanism could compromise the FDA's rigorous safety and efficacy standards, potentially exposing U.S. patients to drugs that have not undergone the full domestic review process. They may express concerns about the potential for adverse events if the FDA's independent oversight is diminished, and question whether foreign regulatory standards are always equivalent or superior to those of the FDA.
The bill is relatively short and its core mechanisms are clearly articulated, making it accessible for a reader to understand its primary intent and operational changes within a reasonable timeframe.
Section 1
Short Title
This section formally names the Act as the "Fast-tracking Approval for Innovative Rare disease therapies Act" or the "FAIR ACT." This provides a concise and recognizable name for the legislation, immediately conveying its primary objective of accelerating access to therapies for rare diseases.
Supporters argue
Supporters argue that a clear and descriptive short title helps in public discourse and legislative tracking, immediately conveying the bill's primary objective of accelerating access to therapies for rare diseases.
Critics contend
No specific opposition is typically raised against the short title of a bill, as it is a standard legislative practice.
Section 2
Congressional Findings
This section outlines Congress's rationale for enacting the bill. It states that U.S. patients face delays in accessing innovative medicines, that the FDA's lengthy process drives clinical trials abroad, and that other nations are expanding their biopharmaceutical capacity, threatening U.S. leadership. It concludes that reciprocal approval will accelerate access and preserve U.S. competitiveness.
Section 3, inserting new Section 524C into the Federal Food, Drug, and Cosmetic Act.
Reciprocal Marketing Approval for Certain Drugs
This provision establishes a mechanism where a "covered product" (drug or biological product) intended for an "immediately life-threatening disease or condition" can be deemed approved in the U.S. if it is lawfully marketed in a foreign country by a "trusted international regulatory authority" (EMA, UK MHRA, Health Canada, or others designated by HHS). The FDA must grant or deny approval within 30 days of a request, and finalize labeling and postmarket requirements during this period. The FDA can withdraw approval if new evidence shows unreasonable risk or if the foreign approval is rescinded.
Section 4, inserting new Section 569B-1 into the Federal Food, Drug, and Cosmetic Act.
Reciprocal Allowance of Clinical Investigations
This provision allows manufacturers to seek "reciprocal allowance" to conduct clinical trials in the U.S. for "qualified products" (those for immediately life-threatening diseases) if the same investigation has been authorized by a "trusted international regulatory authority." The FDA must treat such an application as meeting existing investigational new drug (IND) criteria and issue an order allowing or declining the allowance within 30 days. The Secretary may request protocol modifications but must still act within the 30-day period.