H.R. 6434 — Freedom to Heal Act of 2025

This section establishes a special registration process under the Controlled Substances Act for physicians to directly administer Schedule I eligible investigational drugs (as defined in the Right to Try law, 21 U.S.C. 360bbb-0a) to eligible patients (i.e., terminally ill patients with no comparable or satisfactory alternative therapy). The process requires physicians to submit applications to the Attorney General—including evidence of schedules II-V registration, Right to Try compliance (e.g., manufacturer verification and supply agreement), drug quantity, state law authorization, relevant training, storage site details, and anti-diversion measures—with approvals (or orders to show cause) within 45 days and electronic submission capability. It further provides for (1) possession limits tied to the application or supplemental notifications (deemed approved after 30 days unless show cause issued); (2) single registrations covering related treatment sites within the same city or county under common control; and (3) an interim final rule within 240 days of enactment (followed by a final rule within two years) to implement delivery, storage, records, registration actions, and anti-diversion controls.