The Washington State attorney general’s office appeared alongside lawyers representing cancer patients on Thursday, telling a federal appeals panel that people in end-of-life care deserve legal access to psilocybin—the main psychoactive compound in psychedelic mushrooms—under state and federal right-to-try laws.

“It is entirely consistent with the purpose and language of the state and federal right-to-try laws to include any controlled substances that have completed Phase 1 trials, including Schedule I controlled substances,” Washington Deputy Solicitor General Peter B. Gonick said in oral argument before a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, referring to a category of illegal drugs that includes psilocybin. “It’s entirely inconsistent with the right-to-try laws to prevent patient access to these treatments.”

Congress and 41 U.S. states have adopted right-to-try (RTT) laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. But in the case before the Ninth Circuit, two patients and a Seattle-based palliative care clinic, the Advanced Integrated Medical Science (AIMS) Institute, say the U.S. Drug Enforcement Administration (DEA) is standing in their way.

The group sued DEA in March, after the agency replied to a request for guidance from the clinic’s co-director, Dr. Sunil Aggarwal. DEA asserted that the only way for the AIMS Institute to dispense psilocybin legally would be to obtain a federal research permit, which “would not be applicable to Dr. Aggarwal at this time.”

Out of the gate at oral argument Thursday, judges initially expressed skepticism over whether they even had jurisdiction to hear the case at this point. DEA maintains its letter to the clinic was simply an informal opinion, not a reviewable decision.

“Isn’t that the beginning and the and of this case?” Judge Ryan D. Nelson, an appointee of President Donald Trump, interjected barely 10 seconds after arguments began. “They wrote, seeking instructions on how to proceed… So if they sought instructions, how can a response for instructions ever be a final order?”

Attorney Matthew Zorn, who represented the patients and clinic suing DEA at Thursday’s oral arguments, replied that the agency’s response effectively gave them no options. “That response was: There is no process,” Zorn said. “If they had identified a process, we would have used that process. Because the agency said, ‘There is nothing for you to use,’ there is nowhere for us to go.”

For several minutes, judges on the panel—which also included Trump appointee Judge Mark J. Bennett and Judge Sandra Segal Ikuta, appointed by President George W. Bush—peppered Zorn with questions about whether DEA’s reply was even reviewable under court precedent.

“You didn’t ask [DEA] for an interpretive rule,” Nelson said.

“You asked for guidance,” agreed Ikuta.

“We didn’t ask for it,” Zorn told Nelson, “but that’s what we got.”

“I agree if that’s what you got the case might be different,” Nelson answered with an audible chuckle.

Though Zorn’s allotted time ended with some questions from judges unanswered, the panel’s mood appeared to change as the attorney dissected a federal court decision out of the Eastern District of Tennessee, which Nelson raised as a challenge. Zorn explained how he thought that decision was made in error, running contrary to a U.S. Supreme Court ruling dealing with the U.S. Environmental Protection Agency.

“This is crystal clear. I do think that court erred,” Zorn argued, as Nelson nodded his head.

Speaking after Zorn, Gonick, the Washington State deputy solicitor general, offered arguments on behalf of that state. Lawmakers there, where the AIMS Institute is located, passed a state right-to-try law unanimously in 2017, allowing terminally ill patients access to treatments that have passed Phase 1 of the U.S. Food and Drug Administration (FDA)’s approval process.

“The average time, Phase 1 to FDA approval, is seven to 10 years,” Gonick told judges, “and Congress and 41 states determined that was just too long for some patients suffering life-threatening illnesses.”

The laws express the recognition that some patients “may not have time to wait for FDA approval to receive treatments,” he added, “treatments that currently have ‘no accepted medical use,’ as the drugs in Schedule I have been designated” under the federal Controlled Substances Act (CSA).

The DEA attorney, Department of Justice (DOJ) appellate lawyer Thomas Pulham, argued the case itself should be dismissed because the court lacks jurisdiction. If the agency had explicitly rejected the clinic’s application for a research permit, he said, only then could that decision be appealed.

“DEA’s action is not subject to judicial review, because it neither reflects the consummation of a decision-making process nor results in any legal consequences,” Pulham said. “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.”

The agency also argued to the court in a June filing that loosening restrictions on psilocybin could fuel the illegal drug trade.

Judges were skeptical of the government’s stance, however, and repeatedly asked Pulham how the clinic and its patients should have proceeded, in DEA’s view.

“What about under the Right to Try law, though?” asked Judge Ikuta. “Is there a pathway where they could apply under the Right to Try Act?”

No, the lawyer for DEA replied. “As the agency indicated in its letter, there’s no procedure available under the Right to Try Act, because the Right to Try Act does not provide the agency any authority to waive the requirements of the Controlled Substances Act.”

Pulham argued that if the AIMS Institute and its patients were to proceed with psilocybin therapy and face enforcement action by the DEA, they could raise their right-to-try arguments at that point.

“Usually we don’t require a party to go and subject themselves to liability in order to appeal,” interrupted Judge Nelson. “It sounds like there might actually be some legal consequences here. I mean, it is prohibiting them from doing what they want to do, and it’s subjecting them to enforcement action if they were to go forward.”

“The letter does not do that,” Pulham stressed. “The Controlled Substances Act does that.”

“When Congress passed the Controlled Substances Act, it designated psilocybin as a controlled, Schedule I controlled substance based on findings that the drug had a high potential for abuse and no accepted medical use,” he continued. “That determination made psilocybin, in the Supreme Court’s words, contraband for all purposes, except for one exception, which is research.”

In his few remaining minutes of argument for rebuttal, Zorn emphasized that his clients are merely asking DEA to explain how clinicians and patients should move forward under right-to-try laws. “The agency has said it has no authority to give us what we’re asking for, which is a process to apply for a waiver and exemption to vindicate right-to-try use,” he said, “which is very different from research use.” He also noted that DEA has accommodated some ceremonial use of controlled substances under the Religious Freedom Restoration Act (RFRA), which is also not explicitly exempt from the CSA.

Zorn’s colleagues and clients cheered Zorn’s performance and said they hope it helps persuade the three-judge panel to rule in their favor.

“I am so grateful for such a landmark day in a higher court for us, in which our legal team was able to help in the slow chipping away of the DEA–CSA industrial complex status quo that stymies public health, healthcare, religious freedom, and the needs of the seriously ill,” Aggarwal, co-director of the AIMS Institute, told Marijuana Moment. “Now we await a swift and just ruling.”

Attorney Kathryn Tucker, who also represents AIMS and the patients, said that the panel “appeared over the course of the argument to appreciate that the agency had left no avenue open and hence the matter was properly before the court.”

“The sense I had watching the arguments was that the judges wanted to know how DEA would accommodate RTT and enable access for therapeutic use,” she said. “DOJ had no good answer to that.”

As AIMS and its patients challenge DEA’s restrictions on therapeutic psilocybin for end-of-life care, jurisdictions across the country are increasingly removing or reducing penalties around drug possession and consumption, especially when it comes to psychedelics.

A task force in Seattle, where AIMS is located, recently called on the City Council, as well as state lawmakers and other municipalities, to decriminalize all drugs as a way to curb overdose deaths. The group’s report also notes the potential shown by psychedelics in particular for treating various mental health disorders.

At the state level, Washington lawmakers reduced the state’s felony charge for drug possession to a misdemeanor earlier this year and earmarked more money for treatment following a state Supreme Court decision that overturned the states felony law against drug possession completely.

Not far north, in Canada, the country’s Health Ministry has granted case-by-case approval for some patients, as well as health care professionals, to access psilocybin for therapeutic use.

In California, meanwhile, a Senate-passed bill to legalize possession of a wide range of psychedelics advanced through several Assembly committees this session, but it will not move further this year following a decision by the sponsor that more time is needed to build the case for the reform and solidify its chances of being enacted.

California psychedelics activists also recently filed a petition for the 2022 ballot to make the state the first in the nation to legalize psilocybin mushrooms for any use. Oakland and Santa Cruz have already enacted psychedelics decriminalization. The state’s nonpartisan Legislation Analyst’s Office said this week that the statewide ballot measure could save the state tens of millions of dollars in annual enforcement costs.

In Michigan, the Ann ArborCity Council approved the policy change last year—and local lawmakers recently passed a resolution to officially designate September as Entheogenic Plants and Fungi Awareness Month.

In Massachusetts, cities that have enacted the policy change include NorthamptonSomerville and Cambridge.

In Denver the first city to adopt psilocybin reform, activists are now pushing to expand the psilocybin decriminalization policy to cover gifting and communal use of the substance.

The governor of Connecticut recently signed legislation recently that includes language requiring the state to carry out a study into the therapeutic potential of psilocybin mushrooms, meanwhile, and Texas recently enacted a bill to require the state study the medical benefits of psychedelics for military veterans.

A New York lawmaker introduced a bill in June that would require the state to establish an institute to similarly research the medical value of psychedelics.

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers approved a follow-up resolution in December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.

After Ann Arbor legislators passed a decriminalization resolution last year, a county prosecutor recently announced that his office will not be pursuing charges over possessing entheogenic plants and fungi—“regardless of the amount at issue.”

The Aspen, Colorado City Council discussed the therapeutic potential of psychedelics like psilocybin and proposals to decriminalize such substances at a meeting in May. But members said, as it stands, enacting a reform would be more better handled at the state level while entheogens remain strictly federally controlled.

Activists in Portland, Oregon, meanwhile, are mounting a push to have local lawmakers pass a resolution decriminalizing the cultivation, gifting and ceremonial use of a wide range of psychedelics.

In a setback for advocates, the U.S. House of Representatives recently voted against a proposal from Rep. Alexandria Ocasio-Cortez (D-NY) that would have removed a spending bill rider that advocates say has restricted federal funds for research into Schedule I drugs, including psychedelics such as psilocybin, MDMA and ibogaine. However, it picked up considerably more votes this round than when the congresswoman first introduced it in 2019.

Report provisions of separate, House-passed spending legislation also touch on the need to expand cannabis and psychedelics research. The panel urged the National Institute On Drug Abuse (NIDA) to support expanded marijuana studies, for example

It further says that federal health agencies should pursue research into the therapeutic potential of psychedelics for military veterans suffering from a host of mental health conditions.

When it comes to broader drug policy reform, Oregon voters also approved an initiative in November to decriminalize possession of all drugs. This year, the Maine House of Representatives passed a drug decriminalization bill, but it later died in the Senate.

In May, lawmakers in Congress filed the first-ever legislation to federally decriminalize possession of illicit substances.

DEA Proposes Massive Increase In Marijuana And Psilocybin Production For Research To Develop FDA-Approved Medicines

Photo courtesy of Wikimedia/Mushroom Observer

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