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DEA Judge Schedules 10-Day Hearing On Proposed Ban Of Two Psychedelics Amid Pushback From Researchers

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A Drug Enforcement Administration (DEA) administrative law judge (ALJ) has scheduled a 10-day hearing on the agency’s proposal to ban two psychedelic compounds amid pushback from researchers and advocates.

This is the latest in a years-long rulemaking process that saw the agency propose, withdraw and then re-propose placing 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I of the Controlled Substances Act (CSA).

Now, following a public comment period, DEA ALJ Paul Soeffing has set an administrative hearing on the issue from November 12-22, with a final meeting on November 25, according to a notice the advocacy group Students for Sensible Drug Policy (SSDP) that was shared with Marijuana Moment.

This comes as DEA separately scheduled a December hearing to gain additional input on the Biden administration’s marijuana rescheduling proposal—a move that will delay that reform from potentially taking effect until after the presidential election.

Meanwhile, SSDP was among stakeholders who requested the psychedelics hearing, in hopes of challenging what they view as a lack of evidence justifying DEA’s proposed ban. Researchers have pointed out that DOI and DOC, as currently unscheduled substances, have been key components in psychedelics research that show potential in the treatment of anxiety and depression, for example.

“DOI has been amongst the most widely used compounds to study the role of the serotonin 2 receptor of the last several decades,” Elijah Ullman, chair of SSDP’s Science Policy Committee, said in a press release. “The serotonin 2 receptor is widely accepted as the primary target of psychedelic drugs—which have seen incredible press coverage as possible treatments for depression—but are also critically involved in learning and memory, and mood.”

“The DEA’s proposed rulemaking to place DOI in Schedule I of the Controlled Substance Act defies scientific study and will make it more difficult for researchers to work on the serotonin 2 receptor,” he said.

Researchers have also argued that DEA has failed to meet the statutory burden of demonstrating that either psychedelic compound has high abuse potential. There are no documented cases in medical literature of “distressing responses or death” related to human consumption of DOI, nor has there been any established evidence of a high risk of dependence, SSDP said in a pre-hearing filing last month.

Additionally, the research that has been conducted over the last 35 years on these psychedelics, including studies funded by federal health agencies, has yielded evidence that they may be effective treatment options for chronic, acute and neuropathic pain, addiction to opioids and alcohol and other mental health disorders.

“The DEA, for too long, has had a rubber stamp in their decision-making processes. They have not had to defend their actions,” attorney Robert Rush, who is representing independent researchers for the hearing, said. “I am looking forward to having the DEA defend its decision to criminalize an important research tool that it admits is not being diverted for illicit use.”

“I look forward to the DEA being called to explain themselves in blocking critical research that so many Americans struggling with serious issues may benefit from,” he said. “It is time they answered to the American public.”

In the new notice, the DEA ALJ listed stipulations that both the agency and parties that requested the hearing have already agreed to, including the fact that there’s no documented in medical literature about human use of DOI, no current evidence of physiological dependence on DOI or DOC and that neither substance are “immediate precursors of any controlled substance.”

The scheduling of the administrative hearing comes about two months after a federal court dismissed a case challenging the constitutionality of DEA’s process for adjudicating scheduling actions as the agency seeks to ban the two psychedelic compounds.

Prior to that ruling, DEA had formally cancelled the planned administrative hearing, which came in response to an agency administrative law judge staying the proceeding in light of the now-dismissed lawsuit.

Panacea Plant Sciences (PPS) led the legal challenge, and its CEO David Heldreth told Marijuana Moment on Tuesday that the psychedelics research company “is still fighting the constitutionality of the administrative law judge and hearing process,” with a pending appeal before the U.S. Court of Appeals for the Ninth Circuit.

DEA first attempted to ban DOI and DOC in 2022, only to withdraw the proposal amid pushback from the scientific community. The agency separately withdrew from a proposal to ban five different tryptamine psychedelics in 2022.

Last December, DEA announced that it would be trying to enact the DOC and DOI ban again. The agency’s notice about the scheduling proposal still lacks evidence that directly connects the compounds to serious adverse health events or demonstrated a high abuse potential.

“To date, there are no reports of distressing responses or death associated with DOI in medical literature,” it said. “The physiological dependence liability of DOI and DOC in animals and humans is not reported in scientific and medical literature.”

DEA said that anecdotal reports posted by people online signaled that the substances have hallucinogenic effects, making it “reasonable to assume that DOI and DOC have substantial capability to be a hazard to the health of the user and to the safety of the community.”

It did point to one report of a death of a person who had used DOC in combination with two other unspecified drugs—as well as two reports of hospitalizations that it said were attributable to the use of DOC with other drugs—but scientists say that hardly constitutes reason enough to place them in the most strictly controlled schedule.

In the background of this development, the Justice Department’s public comment on its proposal to move marijuana from Schedule I to Schedule III under the CSA officially closed last month. The newly scheduled administrative hearing on that issue comes after multiple interested parties—including former DEA leaders and state attorneys general—made the request.

Those requests were seen by many reformers as a way not only to push back on the Biden administration’s rescheduling plan but also to potentially delay the formal implementation of the action amid an effort by opponents to shoot it down.

Read the DEA ALJ notice of the administrative hearing concerning DOI and DOC below: 

DEA Says It Can Still Arrest People For Marijuana Regardless Of State Legalization, But It’s ‘Not Our Intent’ To Go After Possession Cases

Image courtesy of Students for Sensible Drug Policy.

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