Freedom to Heal Act of 2025

More access to experimental Schedule I drugs

If enacted, this bill would let certain eligible patients receive Schedule I investigational drugs directly from registered physicians under the Federal Right to Try law. The bill would use the FD&C Act definitions of "eligible investigational drug" and "eligible patient." Doctors who want to give these drugs would have to apply to the Attorney General. Applications would have to show a valid schedules II–V registration, manufacturer verification and a supply agreement, state-law authority to treat, relevant training or credentials, a description of the storage/administration site, and the quantity to be supplied. The Attorney General would have to register a complete applicant or serve an order to show cause within 45 days and must provide an electronic application option. Possession would be limited to amounts listed in the application or in a supplemental notice; supplemental notices would be deemed approved after 30 days unless the Attorney General objects. One registration could cover multiple nearby sites only if they are in the same city or county and run by the same institution. The Attorney General would issue an interim final rule within 240 days and a final rule within two years to prevent diversion and set delivery, storage, recordkeeping, and renewal rules.