The federal appeals panel heard arguments in Friday’s case of a Seattle doctor who is asking the federal government to reschedule the drug psilocybin. This is part of his efforts to allow terminally ill patients with cancer to use it legally to treat depression and anxiety at the end of life.
Lawyers for the physician claim that the Drug Enforcement Administration (DEA), by rejecting the psilocybin rescheduling request outright, missed the mark. They argue that the agency should have instead referred the matter the Department of Health and Human Services to evaluate the substance’s medical use prior to reaching a decision.
Matt Zorn was one of the lawyers representing Dr. Sunil Agarwal. He accused DEA of trying to “control the practice of medicine” during oral arguments.
Aggarwal is working to obtain 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 filed the current case in the U.S. Court of Appeals, Ninth Circuit as a response to the ruling from last year. The doctor submitted a formal petition to DEA in February 2022 to reschedule psilocybin under the federal Controlled Substances Act from Schedule I into Schedule II.
In September of the following year, DEA rejected the rescheduling request, writing to Aggarwal in a letter that “a prerequisite to transferring a drug from schedule I under the CSA to schedule II is that the Food and Drug Administration must conclude that a drug has a medical use that is currently accepted in the United States.”
In the letter, 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 doctor is challenging this denial in the case Aggarwal v. DEA 22-1718. Judges Sandra Ikuta Bridget Bade and Daniel Bress will be hearing the case. Bade and Bress have been appointed by Donald Trump while Ikuta has been appointed by George W. Bush.
According to a May filing that details the five part test that was established by DEA 1992, the government insists Aggarwal’s rescheduling request “didn’t address the five requirements required to prove that a substance had a currently acceptable medical use, let along attempt to satisfy them.”
1. If the chemistry of a substance is reproducible and known, 2. There are sufficient safety studies.
3. There are sufficient and controlled studies that prove efficacy.
4. If the substance has been accepted by experts,
5. The scientific evidence available.
Aggarwal’s lawyers claim that the five-part standard is illegal. Zorn, during oral argument, also denied the notion that the petition did not address the five components. He said that a lengthy review document included with the request “met all the evidence of five-part test,” however, DEA did not evaluate it.
He told the judges of appeal that “this is a simple case.” “They did not even take into consideration the petition we presented to them.”
Zorn said that the DEA was “frontrunning” the practice of medicine by preventing doctors from using treatments that have safety and efficacy data.
In briefs, Aggarwal’s lawyers noted that, in response to the petition, the government acknowledged that “psilocybin (1) is eligible for compassionate use programs (2) has received multiple breakthrough therapy designations (3) is currently in late-stage clinical trials.”
It continues: “Showing a substance achieved the designations above, along with successful Phase I-II clinical trials (and proof from those trials), like the Petition, establishes “currently accepted medical uses with severe restrictions” as a legal matter.
Aggarwal’s lawyers say that while DEA wants to have the appeals panel return the petition back to them, HHS is better qualified to determine the medical potential of psilocybin.
Their brief states that “where, as in this case, a request presents evidence that HHS can conclude that the substance is currently accepted for medical use, with severe restrictions, under previous precedents, then a request must be sent to HHS.” HHS’s superiority over science/medicine will be meaningless if DEA is able to develop a legal standard of ‘accepted medicinal use’, evaluate the evidence and deny petitions on the threshold, without giving HHS a change to weigh in.
The lawsuit challenges the government’s claim that DEA must only refer petitions to HHS if it wants to change its schedule, and not if the agency rejects a request. A brief states that “as far as petitioners are aware, nobody–not a court, not a federal agency, not a scholar–has ever endorsed a view such as the CSA.”
Only Bress, one of the three panelists, asked questions at Friday’s oral arguments. He asked Department of Justice lawyer Catherine Padhi at one point when DEA believed it had to refer a case to HHS.
Padhi avoided the question regarding petitions in general, and instead repeated that Aggarwal’s petition specifically failed to address DEA’s five-part tests. She said that a petition must prove that it is true. This is not what the petition did.
Bress was tough on both sides but seemed to focus his questions on the DEA’s failure to provide a comprehensive explanation for its refusal of Aggarwal’s rescheduling request.
He told Padhi that he was not interested in the arguments of the petitioner.
The government attorney responded, “Well, it’s not like there is any argument in the petition which corresponds to the test DEA has been applying for decades.”
This letter does not say that. “Your brief says it, right?” replied Bress. I don’t see how you can read this into the letter.
Each side had 20 minutes to present their arguments on Friday. Zorn took the lead, using 15 of his 20 minutes to make his case. He reserved five more minutes for rebuttal. Padhi spoke only once and used less than half of the time allotted to him by the government.
Zorn’s argument ended with a plea for compassion on behalf of Aggarwal’s patients.
He said that the only difference between Schedule I drugs and Schedule II drugs that have not been approved by FDA is that doctors like my client and other doctors can use this treatment to treat their patients in severely limited, expanded access scenarios for right-to try scenarios. The DEA is preventing this.
Zorn stated that “my clients and the doctors who are amici came to court because it was a case about terminally ill people.” “Delaying the matter for years on the basis of this illegal five-parts test does not do justice to anyone,” Zorn said.
Padhi didn’t immediately respond to Marijuana Moments’ request for comment.
While Aggarwal’s case has been wending its way through the court system, several studies have strengthened the argument for psilocybin as a legitimate medical treatment. Researchers at Johns Hopkins University and Ohio State University published a study last month that linked psilocybin with “permanent reductions” of depression, anxiety, and alcohol abuse as well as increased emotional regulation, spiritual wellness, and extraversion.
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 resurgence in public interest for classic psychedelics, 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 “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.
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.
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The post Federal Court Hears Challenge to DEA’s Decision To Deny Psilocybin Rescheduling Petition without Consulting Health Officials first appeared on Marijuana Minute.
