Researchers and advocates scored a procedural victory this week in their fight against the Drug Enforcement Administration’s (DEA) proposal to ban five psychedelic compounds, with the agency’s own administrative court agreeing to hold hearings on the matter before the prohibition can be enacted.
DEA faced significant pushback from the research community after posting a scheduling notice for five tryptamines: 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT. Nearly 600 people wrote public comments on the proposed rule, virtually all of them in opposition.
The comment period has historically been where the public’s role in federal drug rulemaking stops. But in this case, several different parties submitted requests to have a legal hearing on the planned ban to demonstrate why placing the psychedelics in Schedule I of the Controlled Substances Act would be unnecessary and have a chilling effect on science.
On Wednesday, Administrative Law Judge Teresa Wallbaum issued an order that sets those hearings into motion. First, DEA will need to submit a prehearing statement by March 28. The researchers, advocates and stakeholders contesting the rule have until April 27. And a prehearing conference will be held virtually on May 4.
The function of the Office of Administrative Law Judges is specifically to adjudicate in cases related to DEA enforcement and regulations. In this case, the opponents of the agency’s proposed ban are hoping the judge will ultimately recommend either a lower schedule or no schedule at all for the five compounds.
That said, the head of the DEA isn’t bound by the judge’s recommendation, and past administrators have ignored them in similar cases.
Still, Matt Zorn, an attorney representing one of the companies protesting the DEA scheduling action, told Marijuana Moment that taking this step is an important way to hold the agency accountable and get answers.
“The administrative process is capturing a lot of interest within the psychedelic space, and the narrative is going to continue” as these hearings proceed.
“It’s a good sign when folks are interested in how our government works and how drug policy is conducted,” Zorn, who has an extensive professional history of litigating against DEA, said. “I think that this will be a positive step forward for folks to understand how this process works.”
Not everyone who takes issue with a DEA regulation is entitled to this type of administrative hearing. Each person or entity that makes a request for a hearing must demonstrate that they would be uniquely impacted by the policy change, adding to the significance of the fact that the judge granted five requests for this one proposal.
It’s also been quite some time since a scheduling proposal was subject to this kind of administrative adjudication.
In 1988, DEA Administrative Law Judge Francis Young famously challenged the agency’s classification of marijuana as a Schedule I drug, arguing that cannabis is “one of the safest therapeutically active substances known to man” and “marijuana can be safely used within a supervised routine of medical care.”
“It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record,” Young said at the time.
The agency, however, ignored the judge’s position and kept marijuana in Schedule I.
In its initial rulemaking filing for the five tryptamines, DEA said that it took into account research and recommendations from the U.S. Department of Health and Human Services (HHS) which found that “these substances are being abused for their hallucinogenic properties,” as well as its own eight-factor analyses, before it made the scheduling proposal.
DEA said in last month’s notice that agencies have identified cases of hospitalizations related to the use of two of the tryptamines. It was only able to cite one death where one of the compounds, 5-MeO-AMT, was found in the person’s system, in addition to alcohol and an antidepressant. DEA acknowledged that “it is unclear what role 5-MeO-AMT played in the death.”
The hearing request letters that were obtained by Marijuana Moment contest the agency’s justification for the proposed ban on the basis that it was not only unnecessary given the limited evidence of abuse potential but would also interrupt the research and development of medicines that could help treat serious mental illnesses.
Meanwhile, a Seattle doctor specializing in end-of-life care recently filed a formal petition with DEA challenging the government’s Schedule I classification of psilocybin, the main psychoactive component of psychedelic mushrooms.
The petition requests the agency to reschedule psilocybin as a less-restricted Schedule II drug, pointing to its relatively low potential for abuse and “exceptional promise in relieving debilitating symptoms in those with intractable and otherwise untreatable illness,” including the severe anxiety and depression that can result from a terminal illness.
Attorneys for Dr. Sunil Aggarwal filed the federal petition almost immediately following a decision by the U.S. Court of Appeals for the Ninth Circuit that dismissed on procedural grounds a lawsuit Aggarwal and two of his terminally ill cancer patients filed against DEA last year. In that case, plaintiffs argued they should be allowed legal access to psilocybin under state and federal right-to-try laws, which are intended to let patients with terminal conditions try investigational medications that have not been approved for general use.
Separately, a bipartisan group of members of Congress sent a letter last month urging DEA to let terminally ill patients have access to psilocybin. The agency, lawmakers said, is “obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.”
Congress and 41 states have adopted right-to-try laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. Lawmakers said that DEA “has failed to abide” by the law.
DEA has increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.
Read the administrative court’s notice of hearings and the related requests below: