A federal appeals panel denied a motion filed by attorneys for a Washington State physician who was trying to reschedule psilocybin in accordance with the federal Controlled Substances Act. A three-judge panel of U.S. Court of Appeals, Ninth Circuit, rejected a doctor’s request to rehear an earlier court ruling that sent the matter back to the Drug Enforcement Administration.
Although the October ruling technically went against DEA the court didn’t send the rescheduling request to the Food and Drug Administration for review as the lawyers for the doctors had requested.
In a petition filed earlier this week for a rehearing, the lawyers asked the panel to reconsider the ruling. They said that the order “didn’t address” their argument that the federal statute “requires” FDA to conduct an “scientific and Medical Evaluation and Scheduling Recommendation.”
The court instead ordered a remand to DEA.
The lawyers of Sunil Aggarwal from the Advanced Integrative Medical Science Institute (AIMS Institute) wrote that this omission had both practical and legal implications for the petitioners. They asked the panel to correct the legal error.
In their request for a rehearing by Aggarwal’s lawyers, they explained that “in a civil case in which one of the parties involved is an agency of the United States, any party can file a petition within 45 days, specifying with particularity every point of law or each fact the petitioner believes that the court overlooked or misunderstood.”
The filing states that “if agencies were able to obtain remands without any consideration of the merits (as ordered by the Court here), such a precedent could encourage them to avoid making substantive decisions,” it says. In other words, a precedent of this kind would encourage agencies to make initial decisions that say fewer, and not more. This would multiply judicial workloads and delay decisions on the merits.
In a single-line decision handed down by the court on Tuesday, it denied the request for a rehearing without giving any explanation.
The DEA could reject Aggarwal’s rescheduling request once again, and maintain psilocybin’s legal status. In October, the doctor told Marijuana Moment that, “we don’t know what to expect.”
We have no way to say that’s what we can expect
— Sunil KumarAggarwal (@humansunil) October 27, 2023
Aggarwal is working to secure psilocybin legally for palliative patients since at least 2020. Initially, he tried to get permission from the regulators to use investigational drugs that are 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 to grant Aggarwal his administrative request did not constitute a reviewable action by the agency.
Aggarwal’s reaction to the ruling from last year is what led to the current Ninth Circuit case. The doctor submitted a formal petition to DEA in February 2022 to reschedule psilocybin to Schedule II, under the federal Controlled Substances Act.
Aggarwal sued in December after the DEA rejected his petition in September last year.
In its ruling in October, the Ninth Circuit panel stated that DEA’s refusal “failed” to “provide sufficient analysis” and failed to “clearly indicate that it had considered the potential problems identified in the petition.”
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.
Aggarwal’s rescheduling attempt has been advancing through the courts. A number of studies have helped to strengthen the case for the legitimate medical use of psilocybin. Just this week, Congress sent President Joe Biden’s (D) a defense measure that included provisions to finance studies into the therapeutic uses of psychedelics like psilocybin or MDMA by military service members.
The American Medical Association published results of a recent clinical trial that found psilocybin to have “strong and persistent antidepressant properties” among people with bipolar disorder.
Another study, published in this month, concluded that and LSD could offer promising therapeutic potential to treat chronic pain on a mechanistic level and an experiential one. What’s more the authors of the analysis noted that the pain-relieving effect of LSD and Psilocybin seems to increase with repeated treatments, unlike opioids which show “decreased therapeutic effects” over time.
Researchers at Johns Hopkins University and Ohio State University published a report in September that connected psilocybin with “persisting decreases” 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.
a study by the American Medical Association in August found that patients with major depression saw a “clinically significant sustained” reduction of their symptoms even after taking just one dose.
A survey conducted by Canadian researchers in October found that psilocybin use can ease psychological distress among people who experienced adverse childhood experiences. Researchers found that psilocybin seemed to have “particularly 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.
These findings don’t apply only to psilocybin. A peer-reviewed Nature study, for example, found that treatment with MDMA decreased symptoms in patients suffering from moderate to severe PTSD. These results could lead the FDA to approve the substance as early as next year.
Below, you can read the full Ninth Circuit decision as well as Aggarwal’s request for a rehearing:
FDA Weighs New Application To Approve MDMA As First-Ever Psychedelic Medicine For PTSD
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