The attorneys for a doctor who wants to reschedule psilocybin to allow him to administer it to terminally ill people are demanding that the Drug Enforcement Administration update its previous agreement to request a review of the psychedelic by the U.S. Department of Health and Human Services.
Kathryn Tucker wrote in a note to Thoman Prevoznik (assistant administrator, DEA Diversion Control Division) that advocacy groups “appreciate the work” of the DEA, which “collects necessary data for transmission to [HHS] In response to the petition, they requested a “scientific and medical evaluation of psilocybin and a recommendation on its scheduling.”
In the letter, it was stated: “Of Course, Psilocybin achieved breakthrough therapy status for treatment resistant depression and major depressive disorders in 2018, and that Phase III clinical studies are underway at the Food and Drug Administration.”
The lawyers are interested in knowing if DEA followed up on their commitment to incorporate the updated research that they had provided, “confirming the safety and efficacy of psilocybin for medical purposes.”
You asked, “Can you tell me if transmittal took place? And if we could offer any further help in moving forward this very important issue?” Tucker—who is representing the Washington State-based doctor Sunil Aggarwal of the AIMS Institute—asked.
The letter states that “Dr. Aggarwal is continuing to care for advanced cancer patients who would benefit from psilocybin-assisted therapy. This will allow them to have a peaceful death process. Patients with progressive diseases do not usually have much time remaining.” He also hopes that moving psilocybin to Schedule II of the Controlled Substances Act (“CSA”) “will facilitate access to new promising drugs under Right to Try laws that contemplate access to those in life-threatening situations.
The letter concludes: “We thank you for respecting the situation of such patients and moving this issue forward as soon as possible.”
News of the DEA’s agreement to request a HHS review, as well as a scheduling recommendation, for psilocybin largely went unnoticed. This is a significant development, considering the fact that Aggarwal had previously petitioned for a rescheduling, kicking-off a long legal fight.
In February, the U.S. Court of Appeals of the Ninth Circuit rejected Aggarwal’s challenge against that denial. The panel affirmed that DEA gave a reasoned explanation for denying Aggarwal’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.
Aggarwal then sued DEA when it rejected his request. 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.
Aggarwal responded to the previous Ninth Circuit decision. 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. In addition, he applied for regulatory waivers to acquire psilocybin.
The DEA refused Aggarwal’s petition on September 20, 2022. They also rejected Aggarwal’s waiver request one month later. Both decisions were challenged by the doctor in his Ninth Circuit appeal.
Oral arguments were heard by the panel in August, last year. Attorneys representing Aggarwal, AIMS and others argued RTT laws would allow for the legal use of controlled substances such as psilocybin. 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 submitted multiple proposals with DEA to cultivate psilocybin or obtain it in other ways to treat RTT-eligible patients. All of them have been denied by the agency.
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Dick Culbert is the photographer.