The Drug Enforcement Administration (DEA) is taking the rare step of holding a hearing on its hotly contest proposal to place five psychedelic compounds in Schedule I—an action that scientists say would significantly hamper emerging research into their therapeutic potential.
DEA said in a notice set to be published in the Federal Register on Wednesday that a hearing will be held on August 22, and any person who can demonstrate that they’d be “adversely affected or aggrieved” by the proposed scheduling decision can request to testify.
The agency first proposed scheduling the tryptamines—4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT—in January. And it faced significant pushback from the research and advocacy communities, receiving nearly 600 messages during a public comment period, with most opposing the rule change and requesting a hearing.
DEA’s own administrative court subsequently agreed that there was a need to hold a hearing on the matter before the prohibition could be enacted.
“In requesting a hearing, the requestors stated that their intention is to present factual information and expert opinion concerning the significance and reliability of the medical, scientific, and other bases that DEA provided in support of the proposed scheduling of the five tryptamine substances,” the agency’s new notice says.
DEA’s Administrative Law Judge Teresa Wallbaum issued an order in February that set the hearings into motion, detailing a timeline for prehearing statements from the agency and stakeholders, as well as setting a date for a prehearing conference in May.
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.
Matt Zorn, an attorney representing a client who has pushed for the administrative hearing, told Marijuana Moment on Tuesday that he’s not currently authorized to get into specifics about the proceeding but he offered that observers should “get your popcorn ready.”
It’s 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 the 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.”
Hearing request letters that were obtained by Marijuana Moment earlier this year contested 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.
Separately, activists staged a demonstration outside of DEA headquarters in Virginia in May, demanding that the agency allow terminally ill patients to access psilocybin therapy.
The event—which involved civil disobedience and arrests—was meant to call attention to DEA’s obstruction of Right to Try statutes at the federal and state level that patients and advocates say should facilitate legal use of psychedelics.
Advocates have pointed out that the Food and Drug Administration (FDA) has already granted psilocybin a “breakthrough therapy” designation.
In February, a Seattle doctor specializing in end-of-life care filed a formal petition with DEA challenging the government’s Schedule I classification of psilocybin, the main psychoactive component of psychedelic mushrooms.
The petition requested 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, Baldeschwiler and another terminally ill cancer patient 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, in January, a bipartisan group of members of Congress sent a letter 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.
Meanwhile, DEA recently revealed that it seized far more marijuana plants—and made significantly more cannabis-related arrests—in 2021 than in recent prior years, despite reform efforts in states and Congress.
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Photo courtesy of Wikimedia.
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