Federal Appeals Court Rules Against DEA in Psilocybin Rescheduling Lawsuit Filed by Doctor Who Wants to Give Psychedelics To Cancer Patients

In a case, a federal appeals court ruled against Drug Enforcement Administration (DEA), in response to a doctor’s request for psilocybin to be rescheduled. The court ruled that DEA did not provide a complete explanation of its decision to deny the petition.

The court, contrary to what the lawyers of the doctor requested, did not send the petition for review to the Department of Health and Human Services.

The ruling, issued Friday by a panel of the U.S. Court of Appeals, Ninth Circuit does not alter the legal status of psilocybin. The rescheduling request, submitted by Sunil Aggarwal, in February 2022 is still alive. It also requires DEA to “clarify its path for denying Aggarwal’s petition or reevaluate Aggarwal’s petition on an unrestricted record.”

Aggarwal is working to obtain psilocybin legally for cancer patients who are terminally ill and receiving end-of life care. He has been doing this since at least 2020. He first tried to gain permission from regulators in accordance with state and federal laws that allow terminally ill cancer patients to try investigational drugs not generally approved.

Aggarwal filed a lawsuit when DEA rejected his request. In early 2022 a federal appeals panel dismissed this lawsuit. They argued that the court lacked the jurisdiction, because DEA’s refusal of Aggarwal’s administrative request did not constitute a reviewable action by the agency. The doctor filed a formal petition for rescheduling, whose denial is a reviewable agency action.

DEA rejected Aggarwal’s petition in last September. In its letter of denial, the agency stated that “a prerequisite to transferring a drug from schedule I into schedule II under CSA is that the Food and Drug Administration must conclude that a drug has a medical use that is currently accepted in the United States.”

DEA stated that “to date, FDA has not articulated a medical use of psilocybin for treatment.” Accordingly, the CSA mandates that psilocybin remains in Schedule I.

The Ninth Circuit panel ruled that the denial had “failed” to “provide sufficient analysis”, and failed to “clearly indicate that it had considered the potential problems identified in the petition.”

The opinion states that “DEA’s letter of denial failed to define ‘currently acceptable medical use with strict restrictions’, the standard applicable for transferring a substance from schedule I into schedule II.”

The panel stated that while Department of Justice attorneys for DEA discussed some of these matters in the course of litigating this current suit, an explanation after the fact did not cut it.

The three-judge panel wrote: “Although DEA addressed some of these issues in appeal, ‘[p]OST hoc explanations by appellate counsel of agency action cannot substitute for agency’s own articulation the basis of its decision.’

The court’s ruling was not published, so it did not set a precedent for the future.

The lawyers for Aggarwal wanted the judges send the rescheduling request to the Food and Drug Administration (FDA), an agency of Health and Human Services. This agency would be better positioned to evaluate the accepted use of psilocybin in medicine. The Friday ruling sent the petition to DEA.

The court stated in a footnote that “given the inadequacy in the DEA denial letter”, “we do no address Aggarwal’s statement that the 21 U.S.C. SS 811 (b) mandates that the DEA refer Aggarwal’s petition to Health and Human Services.

When contacted by phone on Friday, Matthew Zorn, the attorney who argued before the three judges in the case last week, stated that the legal team was evaluating its options. He declined to make any further comments.

Kathryn Tucker is another attorney who worked on this case. She noted the speed at which the court released its ruling in a LinkedIn posting.

She said that the oral argument took place on October 20 and that the decision was issued one week later. I have never seen this court issue an opinion so quickly. This may be due to the court’s impatience with DEA for its slow walk on both this petition to reschedule as well as the request for a waiver of the Right to Try.

While Aggarwal’s case is being heard in the courts, several studies have been published that support psilocybin as a legitimate medicine. Researchers at Johns Hopkins University and Ohio State University published a report last month that linked the use of psilocybin with “persistent reductions” in anxiety, depression and alcohol abuse as well as an increase in emotional regulation and spiritual wellbeing.

The authors of the study stated that these results “are highly consistent with an increasing body of clinical trials, behavioral pharmacology and epidemiological data about psilocybin.” These data are a valuable window into the current resurgence in public interest in classic psychoactives, and the results of concurrent increases in naturalistic use of psilocybin.

In August, a study by the American Medical Association showed that patients with major depression saw a “clinically significant sustained” reduction in their symptoms even after taking just one dose of psilocybin.

A survey conducted by Canadian researchers earlier this month found that psilocybin use can ease psychological distress among people who experienced adverse childhood experiences. Researchers found that psilocybin seemed to have “especially strong benefits for those who experienced more severe childhood adversity.”

The first of its kind analysis, released in June, provided novel insights into how psychedelic assisted therapy may help people who struggle with alcoholism.

The National Institute on Drug Abuse at the federal level has recently begun soliciting proposals to explore the use of psychedelics to treat drug abuse. It plans to fund the studies with $1.5 million.

The findings don’t limit themselves to psilocybin. A peer-reviewed Nature study found, for example, that patients with moderate-to-severe PTSD experienced a reduction in symptoms after treatment with MDMA. These results could lead to FDA approval as early as next year.

Below you can read the complete Ninth Circuit decision in Agarwal v. DEA 22-1718:

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