Politics
Doctor Seeking To Reschedule Psilocybin To Treat Dying Patients Demands DEA Update After Agency Agreed To Initiate Federal Review
Attorneys for a doctor seeking to reschedule psilocybin so he can administer it to terminally ill patients are demanding an update from the Drug Enforcement Administration (DEA), which previously agreed to submit a request for a scientific review of the psychedelic from the U.S. Department of Health and Human Services (HHS).
In a letter to Thoman Prevoznik, assistant administrator of DEA’s Diversion Control Division, attorney Kathryn Tucker said that advocates “appreciate” that the agency was “gathering necessary data to transmit to [HHS] with a request for a scientific and medical evaluation and scheduling recommendation for psilocybin” in response to their rescheduling petition.
“Of course, psilocybin has achieved breakthrough therapy designation for treatment resistant depression in 2018 and major depressive disorder in 2019 and is in Phase III clinical trials at the Food and Drug Administration (FDA),” the letter said.
But the lawyers want to know if DEA has followed through on its commitment and incorporated updated research they provided “confirming the medical efficacy and safety of psilocybin.”
“Can you advise if the transmittal has occurred and if we can offer further assistance in moving this important matter forward?” Tucker—who is representing the Washington State-based doctor Sunil Aggarwal of the AIMS Institute—asked.
“Dr. Aggarwal continues to provide care to patients with advanced and terminal cancer who could benefit greatly from psilocybin assisted therapy, enabling them to experience a more peaceful dying process; the reality for patients with progressive disease is that they do not have much time left,” the letter says, adding that he hopes moving psilocybin from Schedule I to Schedule II under the Controlled Substances Act (CSA) “will enable access pursuant to Right to Try laws, which contemplate early access to promising new drugs for those with life-threatening conditions.”
“We appreciate your efforts to respect the reality such patients face and move this matter forward as promptly as possible,” it concludes.
News that DEA agreed to submit a request for an HHS review and scheduling recommendation for psilocybin largely flew under the radar, and it’s a notable development considering that the agency previously rejected a rescheduling petition from Aggarwal, kicking off a years-long legal battle.
The U.S. Court of Appeals for the Ninth Circuit in February rejected Aggarwal’s challenge to that denial, with the panel affirming that DEA provided a reasonable explanation in denying the doctor’s request.
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.
When DEA rebuffed that request, Aggarwal sued. 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 latest Ninth Circuit ruling resulted from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II—the denial of which was a reviewable action. He also applied for a regulatory waiver to obtain psilocybin.
DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit case challenged both decisions.
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.
Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care. The clinic has presented DEA with multiple proposals to legally cultivate or otherwise obtain psilocybin to treat patients under RTT. The agency has denied them all.
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Photo courtesy of Dick Culbert.
