Federal Court Rejects Washington Doctor’s Effort To Legally Access Psilocybin For End-Of-Life Patient Care

A federal appellate court has rejected the latest effort by a Washington State doctor who is seeking to legally use psilocybin to treat cancer patients in end-of-life care, ruling that the Drug Enforcement Administration (DEA) provided a reasonable explanation in denying the doctor’s request.

In an opinion filed on Thursday, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected arguments from lawyers for Dr. Sunil Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute that DEA’s denial of Aggarwal’s efforts was arbitrary and capricious

“DEA’s decision to deny AIMS’s request was neither arbitrary nor capricious,” the court concluded. “We therefore deny AIMS’s petition for review of the DEA’s decision.”

Aggarwal and AIMS have 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 right-to-try laws.

When DEA rebuffed that request, Aggarwal sued. 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 latest Ninth Circuit ruling results 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 a 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 case challenged both decisions.

“Following the dismissal of its earlier petition, AIMS returned to DEA with a concrete request. AIMS asked EA to exempt Dr. Aggarwal from registration under the CSA, either by finding that Dr. Aggarwal’s proposed use of psilocybin was not covered by the CSA’s registration requirement or by waiving the registration requirement,” Judge Marsha Berzon, a Clinton appointee, wrote for the court in Thursday’s opinion. “DEA declined to take action, and AIMS again petitioned for review. Because DEA’s response was neither arbitrary nor capricious, we deny AIMS’s petition for review.”

The panel heard oral arguments in the case in August of last year. Lawyers for Aggarwal and AIMS argued that RTT laws should open a path to legal use of psilocybin and other controlled substances. But attorneys for the Drug Enforcement Administration (DEA) contended in an April filing that the federal RTT law, signed into law in 2018 by President Donald Trump, “does not provide any exemptions” from CSA restrictions.

“What we’re faced with is a categorical view of the world from the DEA, and that categorical view of the world is that there is no path to access Schedule I substances for therapeutic use,” Shane Pennington, an attorney for Aggarwal, told the panel at the time.

That view, he argued, is at odds with a plain reading of the Right to Try Act.

“Congress said what an eligible investigational drug is,” Pennington said. “Neither the government nor DEA disputes that. If you look at that definition and you just do textualism like you do so well, there’s no way to say that it doesn’t cover psilocybin.”

A separate lawsuit by Aggarwal seeking to reschedule psilocybin under the federal Controlled Substances Act (CSA) was ordered to mediation last year under a joint request from his institute and DEA.

Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care. The clinic has presented DEA with multiple proposals to legally cultivate or otherwise obtain psilocybin to treat patients under RTT. The agency has denied them all.

“DEA has rejected each request,” the clinic argued in its opening brief in the case last year, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”

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

Notably, Washington State and eight other jurisdictions—Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon, Pennsylvania and Washington, D.C.—filed an amicus brief in support of the clinic’s position earlier this year, arguing that CSA doesn’t prohibit the use of controlled substances under RTT.

Many of the same states filed a previous amicus brief in 2021 that said DEA’s rejection of the patients’ application amounted to overreach by the agency

“The CSA was intended to combat drug trafficking and abuse,” said the latest amicus brief, led by the office of then-Washington State Attorney General Bob Ferguson (D), who is now the state’s governor.

“It is irrelevant whether a Schedule I substance has a ‘currently accepted medical use’ under the CSA in the context of uses authorized by the RTT Act,” the brief adds. “The RTT Act’s purpose is to provide a unique, targeted exemption from such requirements.”

Washington State, for its part, adopted its own right to try law in 2017, and dozens of other states have enacted similar policies.

The case is AIMS v. DEA, 22-1568.

Separately in Washington this month, legislative committees heard testimony on a bill to create a regulated system of legal psilocybin services aimed at promoting mental health. But while some commenters said they supported the proposal, most opposed it as either too lenient or, conversely, too restrictive.

If approved, the legislation would allow adults 21 and older to legally use natural psilocybin products, such as dried mushrooms and mushroom tea, with the support of a trained facilitator. Product manufacturers, service centers and testing labs would be licensed by the state.

It’s modeled largely after first-in-the-nation programs in Oregon and Colorado as well as a pilot program in Utah.

Oregon’s Psilocybin Industry Aims To Fine-Tune State’s First-In-Nation Therapeutic Psychedelics System In 2025

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