DEA Failed To Explain Rejection Of Psilocybin Waiver To Treat Cancer Patients, Federal Appeals Court Challenge Says

Lawyers for a doctor in Washington State seeking to legally use psilocybin for end-of-life care argue in a new federal appeals court filing that the Drug Enforcement Administration (DEA) failed to explain a key decision when it denied him access to the psychedelic. They’re asking judges to reverse that move, calling it arbitrary and capricious, and order the government to review the matter anew.

The opening brief filed in the U.S. Court of Appeals for the Ninth Circuit last week is the latest development in what’s become a years-long effort by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute to treat terminally ill cancer patients with psilocybin.

The new action takes aim against DEA’s decision in 2022 to deny Aggarwal’s requests to access psilocybin under state and federal right-to-try (RTT) laws, which give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.

Washington State adopted a right-to-try law in 2017, and then-President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have enacted their own right-to-try policies.

Over the years, Aggarwal has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat his patients, arguing that the federal Controlled Substances Act (CSA) must accommodate a path to legally accessing the substance under RTT laws.

“DEA has rejected each request,” the new brief says, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”

In 2022, DEA rejected a regulatory waiver that would have opened a path to Aggarwal legally obtaining psilocybin. The brief claims the agency had granted similar waivers in the past, but “DEA did not consider his arguments based on the agency’s precedent in this regard, nor did it provide a reasoned explanation for treating his request differently from similar ones it has dealt with in the past.”

“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT,” it continues, “it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.”

Instead, DEA’s decision “denied Petitioners’ request on grounds that permitting Dr. Aggarwal to access psilocybin as the Petition requested would not be ‘consistent with public health and safety,’” the brief says. “As support for that contention, DEA pointed to the statutory characteristics of schedule I drugs and claimed that the proposed activity—permitting psilocybin to be used therapeutically with dying patients under RTT’s terms—presented ‘too great a departure from current law.’”

The brief notes that the Ninth Circuit in October issued a ruling in Aggarwal’s favor on another matter, regarding a separate but related petition to reschedule psilocybin. In that case, judges said DEA failed to explain its reasoning when it denied that petition, and the court ordered the agency to provide a more complete justification, later denying Aggarwal’s request to instead send the petition to the Food and Drug Administration (FDA).

“For the same reason this Court remanded DEA’s inadequate denial letter in Aggarwal less than four months ago,” it says, “it must remand DEA’s Final Decision in this case as well.”

Lawyers for the AIMS Institute say in the opening brief that the court “should grant the petition for review, declare DEA’s Final Decision unlawful, set it aside, and remand this matter to the agency with instructions either to grant Dr. Aggarwal’s Petition or provide the reasoned explanation for denying it” as the law requires.

In short, “DEA denied Dr. Aggarwal’s Petition without addressing key arguments and reasons he raised, including ones based on the statutory text and DEA precedent,” the brief argues. “Was DEA’s Final Decision arbitrary and capricious? Yes.”

Amicus briefs in the case are expected later this week, on Thursday, according to Kathryn Tucker, one of the attorneys representing plaintiffs in the case, AIMS v. DEA 22-1568. DEA’s response deadline is April 8, with a reply from Aggarwal’s lawyers due the next month.

Aggarwal has 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 RTT laws.

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 Ninth Circuit cases stems from Aggarwal’s responses to that 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 denial of which is a reviewable action. He also applied for the regulatory waiver to obtain psilocybin.

DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions.

As Aggarwal’s efforts have made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. In response, Congress late last year sent a defense bill to President Joe Biden (D) that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.

A recent clinical trial published by the American Medical Association, meanwhile, found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder, “with no signal of worsening mood instability or increased suicidality.”

In September of last year, 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.”

Last 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 in October 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.”

Canada, for its part, allowed four cancer patients in 2020 to become the nation’s first people in decades to legally possess psilocybin after being granted permission by the country’s health minister to use the substance for end-of-life care. Later that year, some healthcare professionals also gained the ability to legally possess and use psilocybin themselves.

A survey published earlier this year found that roughly 8 in 10 Canadians believe psilocybin is “a reasonable choice” for end-of-life care.

Read the full petitioners’ opening brief in AIMS v. DEA below:

American Medical Association Says Safe Drug Consumption Sites ‘Save Lives’ By Reducing Risky Behaviors And Overdose Deaths

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