The U.S. Drug Enforcement Administration (DEA) is asking a federal appeals court to throw out a lawsuit aimed at clearing a path to the therapeutic use of psilocybin, the main psychoactive compound in psychedelic mushrooms—arguing that allowing limited medical access could boost the illegal drug trade.
Two cancer patients and a Seattle-based physician specializing in end-of-life care sued the agency in March, seeking legal access to psilocybin under state and federal right-to-try laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use.
DEA wants judges to dismiss or deny the case. In a brief filed on Friday in the U.S. Court of Appeals for the Ninth Circuit, Acting Assistant Attorney General Brian M. Boynton argues on behalf of the agency that the court lacks jurisdiction to hear the dispute and further contended that right-to-try laws don’t actually let patients access drugs that are prohibited under the federal Controlled Substances Act (CSA).
“The Right to Try Act exempts eligible investigational drugs from specifically identified requirements in the [U.S. Food, Drug and Cosmetics Act],” DEA’s brief says. “That exemption does not rescind the CSA or modify the restrictions that the law places on Schedule I substances.”
“On the petitioners’ reading of the Right to Try Act,” it argues, “DEA would be powerless to prevent an unscrupulous doctor from obtaining Schedule I substances from an unregistered manufacturer.”
Allowing psilocybin to be dispensed under federal right-to-try laws would also fuel illicit drug sales, the agency claimed.
“The persistent existence of the narcotics trade despite criminal enforcement efforts ‘suggests that no small number of unscrupulous people will make use of [the Right to Try] exemptions to serve their commercial needs whenever it is feasible to do so,’” the agency brief says, quoting a prior Supreme Court case on marijuana. “Application of the CSA to restrict the use of psilocybin by patients with life-threatening conditions thus furthers the CSA’s main objectives ‘to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.’”
Petitioners in the case—the two patients, Dr. Sunil Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute—will have an opportunity to a reply in a brief due next month. Oral arguments in the case have been scheduled for September 2.
The case stems from a letter Aggarwal and AIMS wrote to DEA this past January asking for guidance on how to move forward on psilocybin under right-to-try laws.
DEA replied 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.”
Lawyers for DEA argued in the new brief that the agency’s decision is not reviewable and that the lawsuit should be dismissed.
“If the petitioners believe that psilocybin should be moved to another schedule so that doctors may prescribe it as a therapeutic treatment, they are free to seek legislative action…or to petition the agency for a rescheduling,” the brief argues. “But nothing in the Right to Try Act disturbed the restrictions on Schedule I substances or Congress’s judgment placing psilocybin in that category. DEA did not err in saying so.”
Last month, however, a bipartisan group of attorneys general from eight U.S. states and the District of Columbia sided with the cancer patients in an amicus brief, noting the therapeutic potential of not only psilocybin but also also currently illegal drugs such as MDMA.
“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,” the top state officials wrote.
The brief likened 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 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.
“Psilocybin is likely not the last Schedule I controlled substance that could be eligible under state and federal RTT laws,” it says. “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.
Other groups that have filed amici briefs in the case include 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.
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.
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.
In Oregon, voters approved historic initiatives to legalize psilocybin for therapeutic purposes and decriminalize drugs more broadly in November.
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 passed the Senate floor earlier this month.
That effort is just the latest as activists step up the push to enact psychedelics reform locally in cities and states across the country.
A California bill to legalize possession of psychedelics passed in the Senate earlier this month. And it’s since been referred to two Assembly committees.
Texas and Connecticut enacted bills this year study the potential therapeutic benefits of psilocybin.
A New York lawmaker introduced a bill this month that would require the state to establish an institute to similarly research the medical value of psychedelics.
The Northampton, Massachusetts City Council passed a resolution in April 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.
Besides the cities in Massachusetts, four others—Oakland, Santa Cruz, Ann Arbor and Washington, D.C.—have also decriminalized possession of plant-and fungi-based psychedelics.
Seattle lawmakers also recently sent a letter to members of a local task force focused on the opioid overdose epidemic, imploring the group to investigate the therapeutic potential of psychedelics like ayahuasca and ibogaine in curbing addiction.
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 reply brief from Justice Department lawyers on behalf of DEA:
DEA Psilocybin lawsuit by Marijuana Moment
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