DEA Advances Psilocybin Rescheduling Petition To Federal Health Officials Following Years-Long Legal Challenge
From toxifillers.com with love
The Drug Enforcement Administration (DEA) has formally requested that federal health officials conduct a medical scientific review on psilocybin in response to a long-pending rescheduling petition.
After initially denying advocates’ request to authorize a review into the psychedelic, last week DEA forwarded the request to move psilocybin from Schedule I to Schedule II of the Controlled Substances Act (CSA) to the U.S. Department of Health and Human Services (HHS) for consideration.
The August 11 transmittal follows an intensive legal back-and-forth between DEA and the petitioners, led by Washington State-based doctor Sunil Aggarwal, who has sought approval to administer psilocybin for end-of-life care of his patients.
The U.S. Court of Appeals for the Ninth Circuit rejected separate arguments from lawyers for Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute, in February—ruling that the Drug Enforcement Administration (DEA) provided a reasonable explanation in denying the doctor’s request for review.
Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal right-to-try laws.
While the federal appellate court’s earlier ruling last October technically went against DEA, the court did not send the rescheduling petition to the Food and Drug Administration (FDA) for review, as lawyers for the doctor had requested.
But now DEA has taken a key step in the rescheduling process, submitting the request to 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.
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 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,” a media advisory from AIM’s legal team says. “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.”
Aggarwal said in a social media post 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 said.
When DEA rebuffed Aggarwal’s 2020 rescheduling petition, the doctor filed suit. And in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.
The panel heard oral arguments in the case in August of last year. Lawyers for Aggarwal and AIMS argued that RTT laws should open a path to legal use of psilocybin and other controlled substances. But attorneys for DEA contended in an April filing that the federal RTT law, signed into law in 2018 by President Donald Trump, “does not provide any exemptions” from CSA restrictions.
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Meanwhile, a federal judge recently ruled against Utah state and county officials in a lawsuit challenging their prosecution of a Provo City-based religious group that uses the psychedelic fungi as sacrament.
This comes about three months after U.S. District Judge Jill N. Parrish granted Singularism’s motion for a temporary injunction and ordered police to return psilocybin that was seized last year as part of a raid at its spiritual center.
As HHS considers the rescheduling petition for psilocybin, the Trump administration is separately looking at a proposal to move cannabis to Schedule III of the CSA. While there are mixed opinions within MAGA circles on the reform, the president said last week that a decision is imminent.
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