Right to Try Gets DEA Oversight: New Bill Creates Special Schedule I Drug Pathway for Terminally Ill Patients

The “Freedom to Heal Act of 2025” is taking aim at a specific, frustrating hurdle in the “Right to Try” landscape: getting access to experimental drugs that are classified as Schedule I controlled substances. Schedule I drugs—think cannabis or psychedelics, which have high regulatory barriers—are often blocked from use, even for terminally ill patients under existing state Right to Try laws. This bill creates a special federal registration process, managed by the Attorney General (meaning the Drug Enforcement Administration, or DEA), to allow physicians to administer these specific unapproved, investigational drugs to eligible, terminally ill patients.

The DEA’s New Role in Experimental Medicine

Under this proposal, the DEA is stepping into the middle of the doctor-patient relationship for a very narrow, high-stakes category of drugs. A physician who wants to administer one of these Schedule I investigational drugs must first apply to the Attorney General for a special registration. This isn't a quick email; the application requires proof of their existing controlled substance registration (for Schedule II-V), documentation that the drug manufacturer is on board and will supply the drug, and an affirmation that the physician will follow the manufacturer’s administration guidance. Crucially, the physician also has to show evidence that their state law actually permits them to treat patients with these drugs, which means access will still be a patchwork depending on where you live.

The Attorney General has 45 days to approve or deny this application. For the patient and physician waiting for a potentially life-saving treatment, 45 days can feel like an eternity. Once registered, the physician is limited to possessing only the quantity of the drug specified in their approved application. If they need more, they have to file a supplemental request, which thankfully gets an automatic green light after 30 days unless the DEA actively steps in to deny it. This mechanism tries to balance regulatory oversight with the urgency of end-of-life care.

Access vs. Oversight: Who Pays the Price?

For terminally ill patients hoping for a breakthrough, this bill is a massive step toward opening up access to promising, yet heavily restricted, treatments. It provides a formal, federal path around the Schedule I barrier. However, the regulatory burden falls squarely on the physicians and the DEA. The bill is vague on what constitutes “relevant training, credentials, or experience,” leaving the door open for the DEA to interpret this narrowly, potentially limiting the pool of doctors who can participate. This could mean patients in rural areas, or those whose doctors haven't jumped through the DEA's specific hoops, might still struggle to find a registered physician.

Another significant detail is the allowance for a single registration to cover multiple treatment sites, provided they are in the same city or county and under the control of the same institution. This is a practical nod to large hospital systems or academic medical centers, but it might leave independent practitioners or smaller specialty clinics facing more complex regulatory hurdles. While the intent is clearly to help patients, the reality is that the DEA, whose primary mission is drug enforcement and preventing diversion, is now tasked with managing access to experimental medicine. This layering of bureaucracy could introduce friction and delays into a process where time is the single most critical factor.