(Reuters) - A Seattle, Washington, clinic on Thursday urged the 9th U.S. Circuit Court of Appeals to order the federal Drug Enforcement Authority to offer a way for terminally ill patients to try psilocybin, the active chemical in hallucinogenic mushrooms, to treat their anxiety and depression.
Much of the argument, before Circuit Judges Mark Bennett, Sandra Ikuta and Ryan Nelson, focused on whether the DEA's conclusion that it could not waive any part of the federal Controlled Substances Act (CSA), which bans psilocybin except for limited research purposes, could even be appealed.
The clinic, the Advanced Integrative Medical Science (AIMS) Institute, asked the agency for permission to use psilocybin under Washington and federal "right to try" laws, which allow terminally ill patients to try drugs that are still under investigation. Forty-one states have passed such laws.
Psilocybin has been the subject of clinical trials to treat terminal patients' anxiety and depression, but remains a so-called Schedule I substance under the CSA, meaning doctors cannot prescribe it.
According to AIMS' petition for review, the DEA responded that there was no way for it to grant a waiver for the use of a Schedule I drug under right-to-try laws.
At the outset of Thursday's argument, Nelson pressed AIMS' attorney, Matt Zorn of Yetter Coleman, to explain what exactly the clinic was appealing.
"How can a response to a request for instructions ever be a final order?" he asked.
"It's because of the specific response in this case, and that response was, there is no process," Zorn said. "Because the agency said there is nothing for you to use, we have nowhere to go."
The state of Washington, represented by Deputy Solicitor General Peter Gonick, weighed in to support the clinic. Gonick said the case raised the "federalism concern that, where possible, statutes should be construed to avoid federal interference with areas traditionally left to states, such as regulation of the medical profession here."
He said that Congress and state legislatures had passed right-to-try laws because they recognized that the federal drug approval process was "just too long" for some terminally ill patients.
Thomas Pulham of the U.S. Department of Justice, arguing for the DEA, said the agency's determination that the CSA did not allow it to grant waivers under right-to-try laws was not subject to review.
"It was an informal response to a request for assistance from a member of a regulated community that did nothing more than provide the agency's view on existing law," he said.
When Nelson asked how the clinic could get the issue before a court, Pulham responded that if it administered psilocybin, and the DEA brought an enforcement action, it could challenge that action as unlawful. The answer did not fully satisfy the judge.
"Usually we don't require a party to go and subject themselves to liability in order to appeal," he said.
The court did not clearly indicate how or when it would rule.
The case is AIMS v. USDEA, 9th U.S. Circuit Court of Appeals, No. 21-70544.
For plaintiffs: Matt Zorn of Yetter Coleman
For Washington: Deputy Solicitor General Peter Gonick
For the government: Thomas Pulham of the U.S. Department of Justice