HR6434-119

What This Bill Does

The Freedom to Heal Act of 2025 adds a right-to-try special registration process to Controlled Substances Act section 303. The Attorney General must register physicians to directly administer Schedule I eligible investigational drugs to eligible patients under the federal right-to-try law. A physician must submit evidence of a valid Schedule II-V registration, right-to-try compliance, manufacturer or sponsor verification that the Schedule I drug is an eligible investigational drug, an agreement by the manufacturer or sponsor to supply the drug and administration guidance, an affirmation that the physician will administer the drug only to eligible patients consistent with that guidance, the quantity to be supplied, evidence that State law allows treatment, evidence of relevant training or credentials, a storage and administration site description, and any additional information needed to prevent diversion. The Attorney General must register the applicant or issue an order to show cause within 45 days of a complete application, must permit electronic submission, and the bill limits quantities, requires security controls, and creates revocation and reporting expectations around diversion and compliance.

Who Benefits and How

Eligible patients benefit because a physician can obtain a federal registration to administer Schedule I investigational drugs through right-to-try when manufacturer supply and State-law conditions are met. Physicians benefit from a defined application path, 45-day decision timeline, and electronic submission process. Manufacturers and sponsors benefit from a clear federal channel for supplying eligible investigational Schedule I drugs with guidance. Drug-development programs may benefit if right-to-try access becomes feasible for Schedule I investigational products.

Who Bears the Burden and How

The Justice Department and DEA must build and administer the registration process, review applications within 45 days, prevent diversion, police quantities, and handle show-cause or revocation proceedings. Physicians must document credentials, State-law authority, manufacturer agreements, storage sites, quantities, and patient eligibility. Manufacturers and sponsors must verify eligibility, supply the drug, and provide administration guidance. Controlled-substance diversion controls may make access slower or more burdensome than ordinary right-to-try treatment.

Key Provisions

• Amends Controlled Substances Act section 303 to create a special registration for Schedule I eligible investigational drugs under right-to-try law.
• Requires physician applications with Schedule II-V registration evidence, right-to-try documentation, manufacturer agreements, State-law authority, credentials, site information, quantities, and anti-diversion information.
• Requires the Attorney General to register the applicant or issue an order to show cause within 45 days after receiving a complete application.
• Requires electronic application submission.
• Limits quantities and ties administration to eligible patients and manufacturer or sponsor guidance.