A bipartisan group of attorneys general from eight U.S. states and the District of Columbia has sided with cancer patients in a lawsuit against the federal Drug Enforcement Administration (DEA) that seeks legal access to psilocybin, a compound found in psychedelic mushrooms, for end-of-life care.
The patients and Seattle-based palliative care physician Dr. Sunil Aggarwal sued DEA in March after the agency denied their application to legally use a synthetic form of the drug under state and federal right-to-try (RTT) laws, which give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.
In a friend of the court brief filed late last week in the U.S. Court of Appeals for the Ninth Circuit, the state attorneys general say DEA’s rejection of the patients’ application was an overreach of the agency’s power. Noting the therapeutic potential of not only psilocybin but also MDMA, the brief urges the court to rule in the patients’ favor.
“Here, dying patients seek access to promising new treatments still in the investigative process—access expressly permitted under both state and federal law—to help them live in peace,” says the brief, filed Friday by Washington State Attorney General Bob Ferguson (D) and joined by Mark Brnovich (R) of Arizona, Kathleen Jennings (D) of Delaware, Karl Racine (D) of Washington, D.C., Kwame Raoul (D) of Illinois, Dana Nessel (D) of Michigan, Keith Ellison (DFL) of Minnesota, David Yost (R) of Ohio and Ellen Rosenblum (D) of Oregon.
The brief likens the situation to one that arose in a 2006 Supreme Court decision, Gonzales v. Oregon, in which the court ruled that the Controlled Substances Act (CSA) didn’t permit the U.S. attorney general to “bar dispensing controlled substances for assisted suicide in the face of a state medical regime permitting such conduct.”
“Once again, the CSA blocks the way,” the attorneys general wrote. “Framing its effort to undermine democratic processes at the state and federal levels as an act of administrative restraint, DEA claims it lacks the authority to waive the CSA’s requirements to permit therapeutic use for these patients.”
The states’ filing stops short of saying the patients are eligible to use psilocybin under Washington’s state law, noting that that by law that decision should be made “by the patient with a terminal illness in consultation with the patient’s health care provider.” But it also suggests that psilocybin is among an emerging class of Schedule I controlled substances under the CSA that may indeed qualify as an investigational drug.
“The States understand that psilocybin treatment of terminally ill patients meets the basic requirement that an ‘investigational drug’ be one that has successfully completed Phase I clinical trials and is now in a subsequent phase of trials,” it says.
“Psilocybin is likely not the last Schedule I controlled substance that could be eligible under state and federal RTT laws,” the brief continues. “For example, the Schedule I substance methylenedioxy-methylamphetamine (MDMA) is the subject of ongoing studies to evaluate the possible efficacy in the treatment of anxiety associated with life-threatening illnesses.”
Washington State adopted a right-to-try law in 2017 and President Donald Trump signed the federal Right to Try Act the following year. So far 41 state legislatures have adopted similar legislation, sometimes—as in Washington—unanimously.
At the crux of the states’ argument is that DEA lacks the authority to nullify state right-to-try laws on the grounds that eligible drugs are forbidden under the federal CSA. “DEA’s refusal to recognize accommodation for state RTT laws in the face of the clear intent of Congress poses a threat to state sovereignty,” the amicus brief says. “This threat is especially acute because it comes from a federal executive agency rather than Congress itself.”
Among organizations filing separate amici briefs in the case on Friday were the Goldwater Institute, a conservative libertarian think tank that has been a leader in drafting and sponsoring state and federal right-to-try legislation, and the ACLU of Washington. A coalition of end-of-life caretakers also filed a brief in support of petitioners, as did a group of law professors and bioethicists.
Dr. Aggarwal’s effort to secure access to psilocybin for his patients began in earnest after state and federal RTT legislation became law. He started looking for legal ways to obtain and use psilocybin in end-of-life treatment, and last November began applying to state and federal regulators for approval to cultivate psilocybin mushrooms privately and use them in treatment.
“We know that it’s a naturally occurring substance that we can cultivate safely, we know how to dose it and there’s really good reason to believe it can help,” he told Marijuana Moment at the time.
Aggarwal also sought psilocybin through commercial producers, but those manufacturers wouldn’t supply the drug without DEA approval, said Kathryn Tucker of Emerge Law Group, lead attorney for the petitioners.
“In the face of an absolute barrier to DEA permission, this lawsuit was filed,” she told Marijuana Moment during a press call on Monday.
Tucker described the states’ brief in the case as “quite a remarkable filing.”
“When you read the states’ amicus, it’s pretty clear that the states come out and say that, yes, certainly there’s going to be a population of patients eligible and that it appears that psilocybin meets the requirements to be deemed an eligible investigational drug,” she said. “And interestingly, the states’ brief goes further and the states say psilocybin is not the only drug that could be at issue here.”
This past January, Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute, wrote to DEA asking for guidance on how to move forward on psilocybin under right-to-try laws.
Instead DEA rejected the application, replying in a February 12 letter that the agency lacks the authority to waive the federal Controlled Substances Act, despite what the federal Right to Try Act says. The only way to dispense psilocybin legally, the agency added, would be to apply for a federal research permit, which “would not be applicable to Dr. Aggarwal at this time.”
Patients, Aggarwal and the AIMS Institute filed an opening brief in their lawsuit earlier this month. A brief from the U.S. Department of Justice is due June 21, and reply briefs are expected through the summer. Oral argument in the case could begin as soon as September, Tucker said Monday.
Health regulators in Canada have already extended legal exemptions to certain patients seeking to use psilocybin in end-of-life care. Officials there granted the first such exemption in August of last year, and in December the country’s health minister said some therapists and health care professionals could also legally use the drug.
This isn’t the first time DEA has found itself battling lawsuits over the criminalization of controlled substances that hold therapeutic value.
Scientists and veterans sued the federal agency last year, arguing that the legal basis DEA has used to justify keeping marijuana in Schedule I of the Controlled Substances Act is unconstitutional. They asked for a review of its decisions to reject rescheduling petitions in 2020, 2016 and 1992. DEA subsequently requested that the court dismiss that suit.
The agency has also been taken to court over delays in approving additional cannabis manufacturers for research purposes.
The Scottsdale Research Institute alleged that DEA has been deliberately using delay tactics to avoid approving cultivation applications. A court mandated that the agency take steps to make good on its promise, and that suit was dropped after DEA provided a status update.
In March 2020, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.
The new psychedelics-related litigation is unique, however, and reflects the growing public interest in loosening laws governing plant- and fungi-based materials, particularly for medical use.
In addition to Oregon’s already enacted policy change, a number of jurisdictions have recently considered or adopted legislation to roll back penalties around psychedelics. A California bill that would legalize the possession of many psychedelics cleared a major procedural hurdle last week and now proceeds to the Senate floor.
That effort is just the latest as activists step up the push to enact psychedelics reform locally in cities and states across the country.
The Northampton, Massachusetts City Council passed a resolution earlier this month to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. It’s the third city in the state to advance the policy change, following Somerville and Cambridge.
These are some of the latest iterations of a national psychedelics reform movement that’s spread rapidly since Denver became the first city to decriminalize psilocybin mushrooms in 2019.
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.
Read the full amicus brief from attorneys general representing eight US states and Washington, DC:
Photo courtesy of Wikimedia/Mushroom Observer