The Drug Enforcement Administration this week forwarded a petition to reclassify psilocybin under federal law to the Department of Health and Human Services to request a medical review of the proposal. The request comes after years of legal debate over the petition and an initial denial of the proposal by the DEA, according to a report from online cannabis and psychedelics news source Marijuana Moment.
The petition was filed by in 2022 by Sunil Aggarwal, a Washington-based physician and co-founder and co-director of the Advanced Integrated Medical Science (AIMS) Institute. He is seeking the change to treat patients in end-of-life care with psilocybin, which has been shown to ease the depression and anxiety of patients with terminal illnesses.
Under the proposal, psilocybin, the psychedelic compound found in so-called magic mushrooms, would be reclassified under federal law. Psilocybin would be removed from Schedule I of the Controlled Substances Act, the most restrictive classification, and placed in Schedule II.
The change would acknowledge that psilocybin has a currently accepted medical use, allowing doctors to prescribe the drug under tightly controlled conditions. Other drugs in Schedule II include oxycodone, morphine and the stimulant Adderall.
On August 11, the DEA formally submitted the rescheduling petition to HHS for a scientific and medical review of the proposal, as well as a recommendation about its potential approval. The department is now led by Secretary Robert F. Kennedy Jr., who has advocated for regulated access to psychedelic therapies.
Psilocybin Designated As ‘Breakthrough Therapy’
The petition from AIMS included evidence on the use of psilocybin for the treatment of mental health conditions. With the FDA previously designating psilocybin as a “breakthrough therapy” and the “abundant clinical trial results supporting rescheduling,” AIMS maintains that “HHS and FDA are in position to quickly provide DEA an evaluation and scheduling recommendation before sending the matter back to DEA to begin the formal rulemaking process required to reschedule.”
“Patients approaching death through terminal illness and Veterans at risk of suicide due to PTSD will be among those benefitted by rescheduling,” the AIM legal team wrote in a media advisory cited by Marijuana Moment. “As soon as psilocybin moves off schedule I, access via Right to Try will be possible for these populations.”
“Leadership in this Administration’s federal agencies, including HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and VA Commissioner Doug Collins, have spoken publicly about their desire and intention to open a path to access to psychedelic therapies, including US Health and Human Services secretary.”
In a social media post, Aggarwal said that “it took us 3.5 years from time of filing to clear this step.”
“Here’s hoping to swift review and smooth sailing from here on out,” he added.
Jack Gorsline, investigative journalist and founder of the Psychedelic State(s) of America on Substack, says that the DEA’s decision to advance the petition to HHS is a groundbreaking development in the effort to reschedule psilocybin under federal law.
“Having covered the first psychedelic compound rescheduling hearing since 1985 from the front lines at the DEA’s headquarters last fall, the monumental, multi-year effort required to challenge the agency’s longstanding bureaucratic status quo from inside the belly of the beast cannot be understated,” Gorsline writes in an emailed statement.
“Considering the snail’s pace at which cannabis rescheduling has progressed over the last half century, this historic advancement of this legal battle to reclassify psilocybin in just three years since co-counselors Kathryn Tucker and Shane Pennington first filed their rescheduling petition has moved at lightning speed in comparison,” he added.