Researchers and lawyers 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 tribunal agreeing to hold hearings on the matter before that the ban cannot be enacted.
The DEA faced significant pushback from the research community after issuing 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 always been where the public’s role in the development of federal drug regulations ends. But in this case, several different parties submitted requests for legal hearings on the planned ban to demonstrate why placing psychedelics on Schedule I of the Controlled Substances Act would be unnecessary and would have a chilling effect on science.
On Wednesday, Administrative Judge Teresa Wallbaum issued an order that triggers those hearings. First, the DEA will have to submit a pre-hearing statement by March 28. Researchers, advocates and stakeholders challenging the rule have until April 27. And a pre-hearing conference will be held virtually on May 4.
The function of the Office of Administrative Law Judges is specifically to adjudicate matters related to the enforcement and regulation of the DEA. In this case, 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 DEA chief is not bound by the judge’s recommendation, and former administrators have ignored them in similar cases.
Still, Matt Zorn, an attorney representing one of the companies protesting the DEA’s programming action, told Marijuana Moment that this step is an important way to hold the agency accountable and get answers.
“There is a lot of interest in the administrative process in the psychedelic space, and the story will continue” as these hearings go.
“It’s a good sign when people are interested in how our government works and how drug policy is conducted,” said Zorn, who has a long professional history of litigation against the DEA. “I think it will be a positive step forward for people to understand how this process works.”
Not everyone who challenges a DEA settlement is entitled to this type of administrative hearing. Each person or entity making a request for a hearing must demonstrate that they would be particularly affected by the policy change, which adds to the significance of the fact that the judge granted five requests for this proposal alone.
It has also been some time since a proposed schedule has been the subject of such administrative arbitration.
In 1988, DEA Administrative Law Judge Francis Young challenged the agency’s classification of marijuana as a Schedule I drug, saying that cannabis is “one of the most therapeutically active substances known to man” and that “marijuana can be used safely as part of a supervised routine of medical care.”
“It would be unreasonable, arbitrary and capricious for the DEA to continue to stand between these people and the benefits of this substance in light of the evidence in this case,” Young said at the time.
The agency, however, ignored the judge’s position and kept marijuana on Schedule I.
In its initial regulatory filing for the five tryptamines, the DEA said it considered research and recommendations from the US Department of Health and Human Services (HHS) which found that “these substances are abused for their hallucinogenic properties”, as well as his own analyzes in eight factors, before making the programming proposal.
The DEA said in last month’s advisory that the agencies had identified cases of hospitalizations linked to the use of two of the tryptamines. He could only cite one death where one of the compounds, 5-MeO-AMT, was found in the person’s system, along with alcohol and an antidepressant. The DEA acknowledged that “the role played by 5-MeO-AMT in death is unclear.”
Hearing request letters obtained by Marijuana Moment challenge the agency’s rationale for the proposed ban on the grounds that it was not only unnecessary given the limited evidence of abuse potential, but that it would also halt research and development of drugs that could help treat serious mental disorders. diseases.
Meanwhile, a Seattle doctor who specializes in end-of-life care recently filed a formal petition with the DEA challenging the government’s classification of psilocybin, the main psychoactive component of psychedelic mushrooms.
The petition calls on the agency to defer psilocybin as a less-restricted Schedule II drug, noting its relatively low abuse potential and “exceptional promise to relieve debilitating symptoms in people with an incurable disease.” and otherwise incurable”, including severe anxiety and depression that can result from terminal illness.
Lawyers for Dr. Sunil Aggarwal filed the federal petition almost immediately after a ruling by the United States Court of Appeals for the Ninth Circuit that dismissed on procedural grounds a lawsuit that Aggarwal and two of his cancer patients in terminally ill filed against the DEA last year. In this case, the plaintiffs argued that they should be allowed to legally access psilocybin under state and federal right to try laws, which are intended to allow patients with terminal illnesses to try experimental drugs that have not been approved for general use.
Separately, a bipartisan group of members of Congress sent a letter last month urging the DEA to let terminally ill patients have access to psilocybin. The agency, the lawmakers said, “obstructs access to psilocybin for therapeutic purposes in accordance with the letter and intent of the Right to Try (RTT) laws.”
Congress and 41 states have passed right-to-try laws, which allow terminally ill patients to try experimental drugs that have not been approved for general use. Lawmakers said the DEA “failed to comply” with the law.
The DEA increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions continued to present obstacles for scientists.
Read the Notice of Administrative Tribunal Hearing and Related Applications below:
Hawaii Senate committee approves bill to legalize marijuana for people age 65 and older