Experimental Schedule I Drugs Could Reach Terminally Ill Patients Faster Under New 'Right to Try' Rules

The “Freedom to Heal Act of 2025” aims to open a new, highly specific door for terminally ill patients seeking access to experimental drugs currently classified as Schedule I controlled substances. If you’re familiar with “Right to Try” laws, this bill plugs a major gap by creating a special registration process for physicians to administer these specific unapproved drugs—think experimental psychedelics or compounds currently in the highest restriction category—but only if they are already designated as an “eligible investigational drug” under existing federal law (Sec. 2).

The DEA Gets Involved in Clinical Trials

This isn’t just an FDA thing anymore; the bill hands significant new administrative power to the Attorney General (AG), who oversees the Drug Enforcement Administration (DEA). A physician who wants to administer one of these experimental Schedule I drugs must apply to the AG, proving they already have a license to handle less-restricted controlled substances (Schedules II-V). They also need documentation from the drug manufacturer agreeing to supply the drug and give guidance, plus evidence that their state allows such treatment (Sec. 2). Essentially, the bill layers a new federal security and compliance check on top of the existing “Right to Try” framework, putting the DEA right in the middle of a patient’s final treatment options.

The Paperwork and the 45-Day Clock

For physicians, this means more paperwork and compliance hurdles. They must detail their relevant training, describe exactly where the drug will be stored and administered, and provide “Any other information the Attorney General deems necessary to prevent diversion” (Sec. 2). That last part is a bit of a wildcard, giving the AG broad, undefined power to request details, which could lead to delays or subjective approval standards. The good news for patients and doctors is the timeline: the AG must approve or challenge the application within a tight 45 days. If a physician needs more of the drug later, they can submit a supplemental request that is automatically “deemed approved” 30 days later unless the AG steps in.

The Transparency Trade-Off

Here’s the part that policy wonks and transparency advocates are raising an eyebrow at. The bill requires the Attorney General to issue an interim final rule to implement all the crucial operational details—like how the drug gets delivered, security requirements, and record-keeping—within 240 days of enactment. Crucially, the bill explicitly allows the AG to skip the standard public notice-and-comment period required by federal law (5 U.S.C. 553) when issuing this interim rule (Sec. 2). While this speeds up access for terminally ill patients, it means the public, physicians, and security experts won't have a chance to weigh in on the rules governing the security and storage of these highly controlled substances until much later, potentially leading to implementation rules that are overly burdensome or impractical for doctors on the ground.