Summary

Creates new FDA pathways that let certain drugs and biologics lawfully authorized by trusted foreign regulators be treated as approved in the U.S. for therapies intended to treat immediately life‑threatening conditions, and allows manufacturers to request permission to run clinical trials in the U.S. when the same trial is already authorized abroad. Applications must be decided within 30 days, include translated dossiers or foreign authorizations, and are subject to postmarket study requirements and FDA authority to suspend or withdraw authorizations for safety reasons. The law also requires a five‑year report on outcomes.

• Creates a reciprocal marketing approval pathway that can treat certain foreign‑authorized drugs/biologics as if approved in the U.S. for immediately life‑threatening conditions.
• Creates a reciprocal allowance to let sponsors run clinical investigations in the U.S. when a trusted foreign regulator has authorized the same trial abroad.
• Requires FDA to accept or deny requests within 30 days and to set labeling and postmarket study requirements during that period.
• Designates trusted international regulatory authorities (e.g., EMA, UK MHRA, Health Canada) and allows the Secretary to add others.
• Gives FDA authority to suspend or withdraw reciprocal approvals for safety reasons or if the foreign authorization is rescinded, including immediate action for early adverse events.
• Treats requests as applications for user‑fee purposes and makes other investigational rules applicable as with standard IND/BLA processes.
• Mandates a five‑year report to Congress on program outcomes, including safety and effects on U.S. clinical research and patient access.