Historic Move Could Transform Psilocybin Access for Terminally Ill Patients
The Drug Enforcement Administration has formally requested that federal health officials conduct a medical scientific review on psilocybin in response to a long-pending rescheduling petition, marking a watershed moment for psychedelic medicine. After years of legal battles, this August 11 transmittal to the Department of Health and Human Services represents the first time the DEA has advanced such a petition for psilocybin.
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| Key Takeaway | Impact |
|---|---|
| First DEA advancement of psilocybin rescheduling | Creates precedent for psychedelic medicine recognition |
| Schedule I to Schedule II potential move | Enables Right to Try access for terminally ill patients |
| HHS review under RFK Jr. leadership | Favorable political climate for approval |
| FDA breakthrough therapy designation | Scientific support for medical efficacy |
| Immediate therapeutic access possible | No need to wait for full FDA approval |
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Years of Legal Battles Lead to Breakthrough
The petition originated from Dr. Sunil Aggarwal, a Washington State physician who has fought since 2020 to legally administer psilocybin to terminally ill cancer patients. After initially denying advocates’ request to authorize a review into the psychedelic—and then committing to move forward with the request in February—DEA last week forwarded the petition following intensive court pressure.
On February 13, 2025, in another setback for common sense drug policy, the Ninth Circuit Court of Appeals issued a decision that initially appeared to block Aggarwal’s efforts. However, this recent DEA action suggests the agency has reconsidered its stance under mounting legal and scientific pressure.
What Schedule II Status Means for Patient Access
The proposed reclassification would fundamentally transform psilocybin availability. Currently as a Schedule I substance, psilocybin is deemed to have no accepted medical use. The move from Schedule I to Schedule II classification would open treatment options for terminally ill patients through existing Right to Try laws.
If psilocybin is moved to Schedule II, it opens the door for legal therapeutic use—especially under federal and state Right to Try laws, which allow terminally ill patients to access investigational treatments prior to full FDA approval. This creates an immediate pathway for compassionate use without requiring lengthy clinical trials.
Political Climate Favorable for Approval
The timing appears strategically advantageous for proponents. HHS, which is headed up by Secretary Robert F. Kennedy Jr., who has advocated for broader access of psychedelic medicine for people with serious mental health conditions, will conduct the review. Kennedy’s non-traditional approach to medicine could prove beneficial for the petition.
According to Vicente LLP founding partner Joshua Kappel, a cannabis and psychedelics attorney, the petition could find a more willing ear in the current HHS administration. Legal experts suggest Kennedy’s unconventional views present a “non-zero” possibility for approval.
Scientific Evidence Supports Medical Value
The FDA has already designated psilocybin-assisted therapy as a “Breakthrough Therapy” for depression, signaling its strong potential in clinical settings. This designation provides crucial scientific backing for the rescheduling argument.
Research has consistently demonstrated psilocybin’s therapeutic potential. A recent clinical trial published by the American Medical Association found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder. Additional studies have shown efficacy for end-of-life anxiety and existential distress.
Immediate Implications for Healthcare
Successful rescheduling would create multiple access pathways. Even a jump down to Schedule II would “really change the calculation under various Right to Try laws,” according to legal experts. Physicians could immediately request psilocybin for qualifying patients without establishing research protocols.
The change would particularly benefit terminally ill patients who currently face impossible legal barriers. “Right-to-try laws should open a path of access for therapeutic use of controlled substances for dying patients, especially those with proven effects like psilocybin”, advocates argue.
Next Steps in the Review Process
The ball is now in HHS and FDA’s court. They are tasked with conducting a scientific and medical evaluation, after which they’ll send a scheduling recommendation back to the DEA. This process typically takes months to complete, though the timeline remains uncertain.
Given FDA’s prior designation of psilocybin as a “breakthrough therapy,” in addition to the “abundant clinical trial results supporting rescheduling,” AIMS contends that “HHS and FDA are in position to quickly provide DEA an evaluation and scheduling recommendation” before initiating formal rulemaking procedures.
This development represents the most significant advancement in federal psilocybin policy since the substance was first scheduled in 1970. Whether HHS will recommend rescheduling remains to be seen, but the scientific evidence and political momentum suggest terminally ill patients may soon gain legal access to this promising treatment.
