Riding on a judicial victory challenging the US Drug Enforcement Administration's (DEA's) denial of a petition to move psilocybin from schedule I to schedule II, the plaintiffs said they will soon be back in court to try to force the agency to allow the use of the psychedelic under state right-to-try laws, which aim to provide terminally ill patients with access to experimental treatments that have not yet been fully approved by the US Food and Drug Administration (FDA).
The petition is just one avenue being pursued by the Seattle, Washington-based AIMS Institute, which is seeking to use the drug to help ease anxiety in patients with cancer.
Last fall, in a scathing response to the DEA, a three-judge panel of the US Court of Appeals for the Ninth Circuit told the agency that it had failed to follow its own procedures and had obfuscated how it came to the conclusion that the petition, filed in 2022 by Sunil Aggarwal, MD, and AIMS, should be denied.
The court said the DEA needed "to either clarify its pathway for denying Aggarwal's petition" or, alternatively, to "reevaluate Aggarwal's petition on an open record." The Ninth Circuit response renders moot a lawsuit filed by Aggarwal to force a DEA explanation of its refusal to reschedule psilocybin.
Shane Pennington, an attorney with Porter Wright who is representing AIMS, said, "it's a huge deal to have DEA's denial of a rescheduling petition declared unlawful and set aside."
"The only thing we didn't get is we wanted the court to direct them to send the petition to the FDA as the statute requires," Pennington told Medscape Medical News.
The 'Right Thing' to Do
The court also did not order the DEA to respond or to do so within any set period. But if the DEA delays "too much," AIMS has the right to go back to court and demand action, Pennington said. "I suspect that if they haven't done anything in 6 months to a year, the court would be frustrated by that," he added.
Attorney Kathryn Tucker, director of advocacy for the National Psychedelics Association, who has also been representing AIMS, said her clients are happy with the Ninth Circuit response. However, they wish the judges had been more directive with the DEA, Tucker told Medscape Medical News.
"We are at a moment where one would hope that the agency will finally stop obstructing and delaying and do the right thing," she said.
Mason Marks, MD, project lead of the Project on Psychedelics Law and Regulation at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, said he does not expect the DEA to approve the rescheduling petition, but that the agency may provide "a more detailed response that actually has some more substance to it."
Marks cites the DEA's long history of refusing to reschedule cannabis, saying it "doesn't really bode well for people who are advocating to reschedule psilocybin."
The agency will likely only reconsider psilocybin when there is an FDA-approved product that it can reschedule, said Marks. For instance, when the FDA approved the cannabis-derived drug Epidiolex in 2018, the DEA moved it to schedule V several months later.
Compass Pathways is developing a psilocybin product, which is currently being tested in trials for treatment-resistant depression. That drug may not be approved until 2027 at the earliest, said Marks. If it were to be approved, "the DEA would reschedule that particular formulation of psilocybin, but that formulation alone," he said.
"It just doesn't seem like there's any possibility that the agency would willingly do anything else before then," said Marks.
Next Best Chance
Tucker said that the next best chance to pressure the agency is through another suit brought by AIMS that seeks to allow use of psilocybin under state right-to-try laws.
In 2021, the DEA denied AIMS' request to waive Controlled Substances Act prohibitions against psilocybin use, citing right-to-try laws. AIMS then sued, and the Ninth Circuit in 2022 threw out the case on a technicality.
But AIMS had an avenue to reframe its arguments, and the case is now again pending before the Ninth Circuit, which is one of the courts that adjudicates administrative law.
AIMS and the federal government are submitting briefs, and arguments could be heard as soon as summer 2024, said Tucker.
For a treatment to be eligible for right-to-try, it must have completed an FDA-approved phase 1 clinical trial; be in an active trial that would form the basis of an application for approval or already is part of an approval application; and be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.
Psilocybin meets all of these conditions, said Tucker. "A single guided treatment with psilocybin therapy for a dying cancer patient has been shown time and again to bring immediate, substantial, and sustained relief. The right to try argument is very strong," she said.
Forty-one states have passed right-to-try laws. Pennington said that AIMS will argue that the federal right-to-try law, which sets a template for states, trumps the Controlled Substances Act. The plaintiffs are asking the court to declare the DEA's refusal to create a pathway for psilocybin use under those right-to-try statutes to be unlawful, said Pennington.
"I believe we will prevail," said Tucker. However, Tucker is also a realist. "There is no quick path to victory here," she said.
Easing Psychological Suffering
She also noted that several pieces of legislation have been introduced in the US Congress that could help facilitate research and allow compassionate use of psychedelic therapies like psilocybin and 3,4-methylenedioxy methamphetamine (MDMA).
The Breakthrough Therapies Act (Senate Bill 689) would expedite the transfer of substances that receive breakthrough therapy designation from the FDA from schedule I to schedule II. So far, both psilocybin and MDMA have been designated as breakthrough therapies. The bill has not received any congressional action since its March 2023 introduction.
Similarly, the Right-to-Try Clarification Act (House Bill 1825) has not seen any action since its introduction. That legislation would specifically exempt drugs eligible for right-to-try from restrictions under the Controlled Substances Act (CSA).
Congressional pressure will not likely move the needle, said Marks. He has argued for reform of the CSA. It would make more sense "to have a public health agency making decisions that at least in theory should primarily be directed at improving public health," he noted.
Arguably, scheduling does not prevent the harms associated with substance use, Marks added. "Scheduling hasn't prevented opioid overdose deaths. I don't know that there's any evidence to suggest that scheduling improves safety in any meaningful way. It does, however, inhibit the ability to do research."
Tucker said she will keep pushing on every available front. "The obvious gap in the palliative care toolbox is a tool for the relief of nonphysical suffering, and psilocybin is that tool."
"It's really essential that everyone in patients' rights, hospice and the palliative care movement stand up and insist that it be available sooner rather than later," Tucker added.
Note: This article originally appeared on Medscape
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