Federal Court Hears Case Challenging DEA Decision To Deny Psilocybin Rescheduling Petition Without Consulting Health Officials

October 21, 2023 · marijuanamoment.net

A federal appeals court panel heard arguments on Friday in the case of a Seattle-based doctor who’s asking the federal government reschedule psilocybin, part of his effort to clear a path for terminally ill cancer patients to legally use the substance to help treat end-of-life depression and anxiety.

Lawyers for the doctor say the Drug Enforcement Administration (DEA) dropped the ball when rejecting the psilocybin rescheduling petition outright, arguing that they agency instead should have referred the matter to the Department of Health and Human Services (HHS) to evaluate the substance’s medical use before reaching a final decision.

Matt Zorn, one of the attorneys representing Dr. Sunil Aggarwal, accused DEA at oral argument of wanting “to control the practice of medicine.”

Aggarwal has been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care. He initially sought to win permission from regulators under state and federal right-to-try laws, which allow patients with terminal diseases to try investigational medications that haven’t been generally approved.

When DEA rebuffed that request, Aggarwal sued. But 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 current case, filed in the U.S. Court of Appeals for the Ninth Circuit, stems from Aggarwal’s response to last year’s ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA).

The following September, DEA denied the rescheduling petition, writing in a letter to Aggarwal that a “prerequisite to transferring a substance from schedule I to schedule II under the CSA is for the Food and Drug Administration (FDA) to conclude that a substance has a currently accepted medical use in the United States.”

“To date, the FDA has not articulated any accepted medical use for psilocybin in treatment,” DEA said in the letter. “Accordingly, the CSA requires that psilocybin remain in schedule I.”

The case heard Friday, Aggarwal v. DEA, 22-1718, is the doctor’s challenge to that denial. The matter is before Judges Sandra Ikuta, Bridget Bade, and Daniel Bress. Bade and Bress were appointed by President Donald Trump, while Ikuta was appointed by President George W. Bush.

The government insists that Aggarwal’s rescheduling petition “did not address the five elements required to show that a substance has a currently accepted medical use, let alone attempt to satisfy them,” according to a filing in May that details the five-part test, which was established by DEA in 1992:

1. Whether the substance’s chemistry is known and reproducible,
2. Whether there are adequate safety studies,
3. Whether there are adequate and well-controlled studies proving efficacy;
4. Whether the substance is accepted by qualified experts; and
5. Whether the scientific evidence is widely available.

Aggarwal and his lawyers maintain that the five-part test is unlawful. During oral argument, Zorn also rejected the idea that the petition failed to address the five elements. A lengthy review paper included with the petition, he said, “meets all of the evidence of the five-part test,” but DEA simply didn’t evaluate it.

“This is an easy case,” he told the appellate judges. “They didn’t even consider the petition that we put before them.”

“DEA is frontrunning the practice of medicine, is preventing doctors to use treatments for which there is safety and efficacy evidence and is doing that using the five-part test,” Zorn continued.

In briefs, Aggarwal’s lawyers noted that the government has acknowledged that the petition “presented evidence showing psilocybin is (1) eligible for use in compassionate use programs, (2) received multiple breakthrough therapy designations and (3) is in late stage clinical trials.”

“Showing a substance has achieved the designations noted above,” it continues, “along with successful Phase I and II clinical trials (and evidence from those trials), as the Petition did, establishes ‘currently accepted medical use with severe restrictions’ as a matter of law.”

While DEA wants the appellate panel to return the petition to the agency, Aggarwal’s attorneys say judges should instead refer the matter to HHS, which is better qualified to make a determination about psilocybin’s medical potential.

“Where, as here, a petition presents evidence such that HHS could conclude that the substance has ‘a currently accepted medical use with severe restrictions’ under past precedents, a petition must be referred to HHS,” their brief says. “HHS’s superior authority over science/medicine is meaningless if DEA can develop a legal standard for ‘accepted medical use,’ evaluate the evidence as gatekeeper, and deny petitions at the threshold without ever giving HHS a chance to weigh in.”

The lawsuit takes issue with the government’s assertion that DEA only needs to refer petitions to HHS when DEA itself seeks to make scheduling changes—not when the agency is rejecting a petition. “As far as Petitioners are aware, no one—no court, federal agency, scholar, or anyone else—has ever endorsed such a view of the CSA,” a brief says.

Of the three judges on the panel, only Bress asked questions during Friday’s oral argument. At one point, he asked Department of Justice (DOJ) lawyer Catherine Padhi exactly when DEA believes it has to refer a petition to HHS.

Padhi dodged the question about petitions generally, instead repeating that Aggarwal’s petition in particular failed to directly address DEA’s five-part test. “A petition has to really make a showing that this is so,” she replied, “and that is something the petition did not do.”

While Bress asked tough questions of both sides, he seemed to zero in on DEA’s lack of a thorough explanation in its denial of Aggarwal’s rescheduling petition.

“There’s no engagement with the substance of the petitioner’s arguments here,” he said to Padhi.

“Well, there’s no argument in the petition that corresponds to the test that DEA has applied for decades,” the government attorney replied.

“This letter doesn’t say that. Your brief says that, right?” responded Bress. “I don’t even see how you could read that into the letter.”

Each side was given 20 minutes Friday to argue their case. Zorn led off, using 15 minutes and reserving five for rebuttal. Padhi, meanwhile, spoke once, using only about half the government’s allotted time.

Toward the end of his argument, Zorn made a human plea on behalf of Aggarwal’s patients.

“The only difference between a Schedule I drug and a Schedule II drug that hasn’t been approved by the FDA,” he said, “is that doctors such as my client, and other, doctors can use that treatment in severely restricted, expanded access for right-to-try scenarios to treat patients. That’s what DEA is getting in the way of here.”

“My clients, and the doctors in the amici, they showed up in this case because this is about terminally ill patients,” Zorn said. “Delaying this matter for years based on this unlawful five-part test doesn’t do justice for anyone.”

Padhi did not immediately respond to Marijuana Moment’s request for comment.

Even as Aggarwal’s effort has wended its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. Last month, for example, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion.

Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”

In August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.

And a survey by Canadian researchers published earlier this month said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.”

A first-of-its-kind analysis released in June offered novel insights into the mechanisms through which psychedelic-assisted therapy appears to help people struggling with alcoholism.

At the federal level, the National Institute on Drug Abuse (NIDA) recently started soliciting proposals for a series of research initiatives meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.

The findings aren’t limited to psilocybin. For example, a peer-reviewed study published in the journal Nature recently found that treatment with MDMA reduced symptoms in patients with moderate to severe PTSD—results that position the substance for approval by the Food and Drug Administration (FDA) as soon as next year. (Full Story)

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