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Today’s lead story is a recap of last week’s FDA hearing on psychedelic therapy, where a familiar debate surfaced on the national stage: Do psychedelics heal on their own, or do they need therapy to work? You can find our recap immediately below!

If you keep scrolling you’ll find stories on newly engineered lab mice specifically for the testing of psychedelics, the forgotten psychedelic legacy of Africa, a stunning art installation at Burning Man, and more.

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The FDA listened to four hours of testimony from advocates, researchers, and industry figures to determine how psychedelic therapy should reach patients.

The Food and Drug Administration (FDA) convened a hearing on psychedelic therapy on Monday, Sept. 14, taking testimony from dozens of advocates, researchers, and industry figures. Just shy of four hours, the hearing was intended to obtain feedback and perspectives on issues associated with the therapeutic use of psychedelic substances in supervised settings.

80 witnesses were invited to attended the meeting, each getting two minutes to make their case supporting psychedelic therapy and flagging concerns to the FDA. More than 1,800 people registered to attend the meeting in-person and virtually by the weekend prior, according to Marta Sokolowska, the deputy director for substance use and behavioral health at the FDA’s Center for Drug Evaluation and Research.

The hearing took place not long after President Trump signed Executive Order 14401, fast-tracking psychedelic research, and in turn putting pressure on the FDA to push psychedelics toward approval faster. "This executive order establishes a policy of accelerating innovative research models and appropriate drug approvals to help increase access to psychedelic drugs for serious mental illness,” Sokolowska said during her opening remarks of the hearing.

She also laid out what the FDA has done already to advance psychedelic drug development. In April, the agency issued national priority vouchers — specifically to COMPASS Pathways for its psilocybin drug, COMP360, for treatment-resistant depression; Transcend Therapeutics for its methylone candidate, TSND-201, for PTSD; and USONA Institute for its investigational psilocybin drug, for major depression — which are intended to speed up regulatory review. The agency also cleared an early-phase study of noribogaine hydrochloride, a derivative of ibogaine, to understand if it has efficacy in treating alcohol use disorder. In July, the FDA then signed a data-sharing agreement with the Department of Veterans Affairs covering the treatment of substance use disorders and mental health conditions. It finalized its guidance for companies developing psychedelic pharmaceutical drugs and also announced this hearing. Then, last week, several FDA officials published a commentary in the New England Journal of Medicine laying out the agency’s new framework for drugs.

The listening panel at the hearing was comprised of representatives from the FDA, the National Institute on Drug Abuse, the VA, the Substance Abuse and Mental Health Services Administration and the Advanced Research Projects Agency for Health. Upwards of 300 people filled the room at the agency’s White Oak campus in Maryland, with about 1,000 more people live streaming in, according to Psychedelic Alpha. Dayle Cristinzio, the FDA’s director of public engagement, moderated and set the terms. The hearing was “not intended for the promotion of any specific drug or commercial product,” she said. Written comments stay open until Oct. 5.

After opening comments, the 80 witnesses who were there to provide public comment took the podium. While the comments ranged widely, a common topic of debate quickly came up in front of the FDA: whether a psychedelic is healing on its own or if needs to be coupled with therapy to be an effective mental health treatment. The difficulty, at least for the FDA, is that it only approves drugs based on safety and efficacy; it does not regulate therapy. This left some speakers worried it would judge these compounds in isolation and treat the care around them as an afterthought.

Lawrence Leeman, a professor at the University of New Mexico School of Medicine and who’s also an addiction medicine specialist, was among those who brought this up. He told the panel that training and credentialing should include a strong focus on psychedelic-assisted therapy including preparation and integration, rather than limited to a focus on medication administration. He explained that this is especially true for PTSD treatment.

Geoff Bathje, a psychologist and ketamine-assisted therapist, didn’t hold back his criticisms about how the FDA handles the therapy component in psychedelic reseach. “I've been disappointed to see the FDA minimize the importance of the therapeutic relationship in psychedelic research for the sake of isolating drug effects in clinical trials."

Not everyone agreed that therapy should be a mandatory part of the clinical psychedelic experience. Peter Hendricks, a professor at the University of Alabama at Birmingham who, at this point, has run psilocybin trials for more than a decade, argued that requiring psychotherapy across every treatment model would ultimately limit access. "A framework that requires a psychotherapy license for every role would fall hardest on the people least able to find care elsewhere," he said. "The people who enroll in my trials are disproportionately low-income, uninsured, and served by public systems that already cannot fill their behavioral health positions."

Hendricks suggested the FDA specify on each product’s label what the evidence supports for how each drug should be administered — either with safety monitoring, psychological support, or psychotherapy. Labeling has already shown to be an issue for affordability and access. Amna Aslam, a representative for the brain-medicine network Radial, told the panel that insurers build coverage rules from a drug’s label, so every vague term becomes a reason to deny a claim. She pointed to esketamine, a ketamine nasal spray drug approved in 2019 for depression, as an example which took five years to reach scale due to a lack of payment infrastructure. "Approval alone is not access," she said. "A breakthrough therapy nobody can reach is not a breakthrough. It is a press release."

The speakers held differing opinions about how cautiously the FDA should move once these drugs reach the public. Christian Reed, a retired Green Beret who volunteers with a veterans organization and spoke on behalf of at-home ketamine company Mindbloom, urged the panel not to confine treatments to clinics. "As you weigh treatments for approval, I'd ask you to weigh access and feasibility as seriously as safety," he said. "That means not locking this inside clinics in a handful of major cities and not weighing it down with so much overhead that insurers won't cover it."

Eddie Jacobs, a researcher at the University of Oxford working in a lab at Johns Hopkins, argued for the opposite. Citing meta-analysis from his lab that still found serious adverse events even under the tight controls of clinical trials, he recommended that the agency start conservatively. “We recommend an initial safety floor anchored closely to the trial context," he told the panel, acknowledging it could limit access in the short term. "But it's better to start with stronger protections and adjust them as the evidence accumulates."

Amber Barnato, who directs the Dartmouth Institute for Health Policy and Clinical Practice and is a certified psychedelic-assisted therapy facilitator, offered reasonable caution. “I believe that FDA approval of access [for terminally ill patients] is ethically defensible," she said. “But ongoing comparative effectiveness research remains critical." She stated that the evidence supporting the efficacy of these treatments remains low and drawn from "small, functionally unblinded trials.”

The clearest dissent came — of course — from Kevin Sabet, infamous drug warrior for Smart Approaches to Marijuana and a former adviser to the Office of National Drug Control Policy. "I can probably confidently say I'm one of the few here without a financial interest in the expanded use of psychedelics, which I think is something we should absolutely be concerned about," he said. “Psychedelics should earn approval the way any other class of drug does, through science and trials, not politics or podcasters."

Others urged the FDA to remain cautious with approval, although these warnings were not opposing psychedelics altogether. One concern was the cultural impact of FDA approval and the need for public education around these drugs, as normalization and non-clinical use will likely accelerate once they receive an FDA sign-off. Susan Taymor Sagy, co-founder of the Coalition for Psychedelic Safety and Education, told the panel that her 21-year-old daughter died following psychedelic use. "I strongly support rigorous research into therapeutic potential for psychedelics," she said. "But as we move toward possible FDA approved psychedelic therapies, we need to think beyond the clinic."

For all the testimony, the federal panel asked nothing of the 80 speakers who provided testimony. Psychedelic Alpha reported that microphones had been set out at each of the nine panelists' seats and went untouched. The only official words of the afternoon were Sokolowska's prepared remarks.

The FDA has plenty of testimony to sift through and considerations to manage before it issues its first psychedelic drug approval. As it stands, droves of Americans are already using psychedelics well ahead of official regulation, and approval would only increase the number of people seeking them out.