Will a court ruling push the DEA to reschedule psilocybin?

This recent, informative Medscape Psychiatry article comments: "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 … 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 … 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 … 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.  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."

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