H.R. 7953 — FAIR ACT

This section states four congressional findings regarding delays in U.S. patients' access to innovative medicines relative to other nations, the Food and Drug Administration's regulatory process contributing to clinical trials moving abroad, competition from China and other countries in biopharmaceutical development, and the benefits of reciprocal approval mechanisms with trusted international regulators.

This section establishes a reciprocal marketing approval pathway deeming covered products (i.e., drugs, including biologics) lawfully marketed by a trusted international regulatory authority in a foreign country as approved under FDA's section 505(c) (new drugs), 510(k) (devices), or Public Health Service Act section 351(a) (biologics) pathways, if intended to diagnose, treat, or mitigate an immediately life-threatening disease or condition (as defined in 21 C.F.R. 312.300(b)(1)) and other criteria are met (e.g., no prior U.S. approval or safety-related rescissions domestically or abroad). The sponsor must submit a request with required information, including an English translation of the foreign dossier; FDA must grant or deny within 30 days, finalizing labeling and any postmarket studies during that period; and the pathway applies other FD&C Act provisions (including fees) as for standard approvals, with authority for FDA to withdraw or suspend on new safety evidence or foreign rescission (potentially with phase-out and patient transition). Not later than five years after enactment, FDA must report to specified congressional committees on the program's effectiveness in accelerating access to innovative medicines, approvals/denials granted, patient safety impacts, and recommendations for continuation, modification, or termination.

This section establishes a process for reciprocal allowance of clinical investigations of qualified products—defined as covered products (per section 524B) intended for the diagnosis, treatment, or mitigation of immediately life-threatening diseases or conditions—authorized by trusted international regulatory authorities. A manufacturer may apply by submitting the foreign authorization and supporting documentation; the Secretary must treat the application as satisfying IND criteria under section 505(i) (for drugs) or section 351(a)(3) of the PHS Act (for biologics), may request protocol modifications, and must allow or decline the allowance within 30 days, with other IND provisions applying.