Freedom to Heal Act of 2025

Key Points

• The bill creates a special DEA registration letting doctors directly give terminally ill or seriously ill patients Schedule I investigational drugs, which are normally banned because the government considers them to have no accepted medical use.
• To get this registration, a doctor must already be licensed to handle other controlled substances, get written proof from the drug maker that the treatment qualifies, and agree to follow the manufacturer's guidance exactly.
• The Attorney General has 45 days to approve an application or start a formal process to deny it, giving patients with limited time a faster answer than typical drug approval timelines.
• The bill sets strict limits on how much of the drug a doctor can possess at once and requires notifying regulators before adding new treatment locations, aiming to prevent diversion of these controlled substances.
• The Attorney General must write detailed implementation rules within 240 days of enactment, skipping the usual public comment process at first, then issue a permanent final rule within two years after that.