Trump’s pick to lead the DEA gets confirmed; FDA opens “priority voucher” for new drugs; and Inhalable DMT research remains on hold
Plus: California’s Gov. Newsom says he remains open to psychedelic reform and Psychedelic therapy training programs in flux
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Trump’s pick to lead the DEA gets confirmed
On Tuesday, the U.S. Senate confirmed Terry Cole, President Donald Trump’s pick to lead the Drug Enforcement Administration. Cole has worked at the DEA for over two decades. After Trump nominated him for the agency’s top administrator role in March, CNN reported that former colleagues wrote a letter to lawmakers raising questions about his role in two deadly incidents in Colombia and Mexico. At an April hearing, Cole sidestepped questions about his position on the in-progress proposal to move cannabis from Schedule 1, the most restrictive category of controlled substances that also includes heroin and most psychedelics, to the less restrictive Schedule 3 category. But Cole did say it was “one of my first priorities” to examine the proposal.
Cole has not publicly spoken about psychedelics, but his stance on rescheduling cannabis could have implications for the potential of rescheduling psychedelics as well. MAPS interim co-executive director Ismail Ali released a statement encouraging Cole’s DEA to keep an open mind towards the substances. “Mr. Cole has an opportunity to lead the DEA toward an approach that meaningfully reduces the social burdens of substance use disorders, criminalization, and stigma. Patients, practitioners, and researchers—especially those working to address mental health and addiction—cannot afford another era of indecision cloaked in bureaucratic process,” Ali wrote. “There are glimmers of progress: the introduction of legislation in Congress, attention from federal agencies, and reports of high-level officials engaging in substantive discussions about psychedelic therapies suggest a hopeful horizon.”
FDA opens “priority voucher” program for new drugs
In other federal agency news, U.S. Food and Drug Administration Commissioner Marty Makary announced that the agency is now accepting applications for its new “Commissioner’s National Priority Voucher” pilot program, which will grant vouchers to companies for accelerated approval of drugs that address “national health priorities.” According to the FDA’s announcement, those priorities include “addressing a U.S. public health crisis” and “addressing a large unmet medical need,” and companies chosen for the vouchers will have new drugs reviewed in 1-2 months instead of the usual 10-12 months. Psychedelic drugs could, in theory, meet those priority criteria. In response to the news, atai co-founder (and former CEO) Florian Brand posted on X that he was “confident that psychedelic drug developers and ultimately patients will greatly benefit from this new FDA pilot program.” To our knowledge, no psychedelic company has publicly stated their intention to apply for the program.
Inhalable DMT research remains on hold
On Wednesday, GH Research, a Dublin-based biopharma company announced that the Food and Drug Administration has continued their clinical hold on GH001, a synthetic, inhalable form of 5-MeO-DMT. The FDA can force a company to pause or hold clinical research if they believe there are safety concerns, lack of information, or flaws in the study design. In GH Research’s case, the hold has been in place for more than a year over concerns related to its inhalation device — but the research still managed to generate excitement in February after GH Research released topline results from a Phase 2 study suggesting that people with treatment-resistant depression benefited from the drug. Shortly after, the company’s stock price nearly doubled.
In June, GH Research announced that they had officially submitted a response to the FDA’s concerns. The company did additional studies examining how its inhalation device affects the respiratory tracts of dogs and rats. It would appear that despite this new data, the FDA is still not allowing research to continue. According to GH Research, the FDA has requested additional data.
Shortly after the news broke on Wednesday, GH’s stock plummeted from $17 to $13. By close of market on Thursday, shares bounced back up to $14.50.
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California’s Gov. Newsom says he remains open to psychedelic reform
Last week, California Governor Gavin Newsom appeared on former Navy SEAL Shawn Ryan’s podcast for a wide-ranging conversation which included psychedelics policy. (In April, Ryan also talked about psychedelics with Veterans Affairs Secretary Doug Collins.) In the interview with Newsom, Ryan spoke enthusiastically about the healing potential of psychedelics, making some dubious claims, like that ibogaine can “cure an opiate addiction in 12 hours.”
Newsom mentioned the tension between a regulated medical framework versus a more permissive one “where you could see more recreational as opposed to medically supervised uses,” but said he has been moved by veterans’ personal stories of healing. “You’ve convinced me,” he said. “It’s now just landing the plane on exactly what the language looks like,” he said. Newsom did not elaborate on what that language might be, but this is not the first time he’s asked for more specific guardrails for access to psychedelics. In 2023, Newsom vetoed a 2023 California bill that would have made it state-legal for people over 21 to possess, prepare, grow, gather, gift, and transport a variety of psychedelics found in plants and fungi. In a letter explaining his decision, he wrote that “California should immediately begin work to set up regulated treatment guidelines — replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses.”
Newsom’s letter continued: “Unfortunately, this bill would decriminalize possession prior to these guidelines going into place, and I cannot sign it.” He encouraged the legislature to introduce bills that address therapeutic guidelines, but the three California bills proposed in the two legislative sessions since his veto have not advanced out of committee to be voted on by legislators.
Psychedelic therapy training programs in flux
A new report commissioned by Harvard Center for the Study of World Religions reviews the state of psychedelic training programs. The researchers, affiliated with both Harvard and Emory, conducted interviews with representatives from 13 psychedelic facilitation training programs to learn about their admissions and faculty selection criteria, teaching strategies and program priorities, and challenges. (Disclosure: The training program previously affiliated with the Berkeley Center for the Science of Psychedelics was among those included.)
Overall, the report shows that psychedelic facilitation programs are in a moment of evolution as the field matures, and the psychedelic industry as a whole faces strong headwinds in the aftermath of the FDA’s decision last summer to not approve MDMA-assisted therapy to treat PTSD. Leaders of “Multiple programs expressed concern about the uncertainty of post-certification prospects for trainees,” the report says. “Many mentioned that the current training market appears to be over-saturated, and that inadequate practicum and practice opportunities represented a bottleneck in training.” As a result of those shrinking opportunities and the opening of new training programs, programs have been seeing fewer applicants.
Denver alt-weekly Westword has a story about the Federally Recognized American Tribes and Indigenous Community Working Group’s report that, according to the publication, “recommends that Colorado halt the implementation of regulated psilocybin therapy and refrain from creating similar therapeutic offerings for mescaline, ibogaine and DMT in healing centers.” The working group was established by the Colorado Department of Regulatory Agencies (DORA) in accordance with the laws that voters passed to create the state’s Natural Medicine Health Act. The working group report cited concerns over cultural appropriation, biopiracy and overharvesting. Read the complete report here.
For NPR member station WUNC’s American Homefront Project, journalist Robin Berghaus reports on Texas’s new ibogaine initiative.
On his podcast Newt’s World, former U.S. Speaker of the House Newt Gingrich talks with the co-founders of ibogaine company Ambio about their treatment facilities and the potential of the drug.
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