FAIR ACT

The FAIR ACT creates a reciprocal approval mechanism for drugs and clinical trials for life-threatening diseases, allowing the FDA to fast-track approvals based on authorizations from trusted international regulatory authorities. It amends the Federal Food, Drug, and Cosmetic Act to establish a new process for marketing approval and clinical trial allowances.

Sec. 3, Reciprocal marketing approval for certain drugs: The FDA must grant reciprocal marketing approval for a covered product (a drug or biological product for an immediately life-threatening disease) if the sponsor requests it and shows the product is lawfully marketed in a foreign country by a trusted international regulatory authority (such as the European Medicines Agency, UK's MHRA, or Health Canada), is not already approved in the U.S., and has not had its foreign authorization withdrawn due to safety concerns. The FDA must decide within 30 days, finalize labeling and post-market studies in that period, and can withdraw approval if new evidence shows serious risks or if the foreign authority rescinds approval. Fees apply as for standard applications, and a report to Congress is due after 5 years.

Sec. 4, Reciprocal allowance of clinical investigations authorized by trusted international regulatory authorities: A manufacturer can seek reciprocal allowance to conduct a clinical trial for a qualified product (a covered product for a life-threatening disease) by submitting an application with the foreign authorization and supporting documents. The FDA must treat the application as meeting criteria for an investigational new drug application and issue an order allowing or declining the trial within 30 days. The FDA may request protocol modifications within that period but must still decide within 30 days.