On September 6, the Reagan-Udall Foundation for the Food and Drug Administration, an independent nonprofit created by Congress in 2007 to support the FDA’s mission, hosted a public meeting in Washington, DC, to discuss the latest advancements in post-traumatic stress disorder (PTSD) treatment. Psychedelics were high on the agenda.
The meeting featured a panel of representatives from various United States government agencies and research institutions, including the FDA, the Department of Defense, Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA).
“Four percent of men and 10 percent of women in the US will have PTSD in their lifetimes.”
Dr. Bernard Fischer, the deputy director of the FDA’s division of psychiatry, began the event with a presentation summarizing the history of PTSD andongoing research efforts to address its growing prevalence. He highlighted that roughly “four percent of men and 10 percent of women in the US will have PTSD in their lifetimes.”
Dr. Fischer noted that there are currently two FDA–approved SSRI medications for treating PTSD (Zoloft and Paxil), but acknowledged that there is still “an unmet need for safe and effective therapies.” He then touted the FDA’s designation of certain psychedelic drugs and compounds as “breakthrough therapies,” and pointed out that “ClinicalTrials.gov shows there are 447 clinical trials [both currently] recruiting [and] not yet recruiting” in this area.
Dr. Leith States of HHS followed up by referencing the controversy over the FDA’s August rejection of Lykos Therapeutics’ Novel Drug Application for MDMA-assisted therapy to treat PTSD.
“We all feel some type of way about the decision that came out some time ago. And that’s okay,” said Dr. States, who serves as chief medical officer in the HHS Office of the Assistant Secretary for Health. “We’re all big kids,” he added, without sharing his personal opinion on the matter.
Immediately after the panel discussion, members of the public added lively and passionate commentary, both in person and via video link. Thought leaders with differing perspectives on psychedelics weighed in on the US mental health crisis from a number of angles.
Dr. Neşe Devenot of Johns Hopkins University shared that “as a survivor of complex PTSD … I understand acutely how important it is to find effective treatment options for this life-altering condition.”
Dr. Devenot, a board member for the Psymposia psychedelic research and education nonprofit, has been a prominent critic of Lykos and the Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit from which the company spun off. Chief among Psymposia’s criticisms are allegations of substantial omissions of adverse events and additional research misconduct during Lykos’s Phase 2 trials.
Dr. Devenot emphasized to the meeting that “the urgency for treatment options is not a license to lower our standards for research, despite the efforts of industry lobbyists to suggest otherwise.”
“All I have heard today is that we are kicking the can down the road.”
Conversely, US Army and Marines veteran Jon Lubecky, a longtime veterans’ mental health advocate, lamented the lack of action by the government officials in attendance. “All I have heard today,” he said, “is that we are kicking the can down the road.”
Lubecky is a former participant in a MAPS clinical trial of MDMA-assisted therapy, and a prominent critic of Psymposia’s conduct. He described to the meeting how he had benefited from his trial participation, stating that “[my] VA medical record as well as my demonstrated actions show that my PTSD is in full remission following the three-month protocol.”
Lubecky played an instrumental role in the crafting and passage of a historic 2023 bipartisan-backed budgetary amendment, which carved out federal funding for veteran-focused psychedelic research. The deal has become known as the Crenshaw Amendment, after US Representative Dan Crenshaw (R-TX), another veteran, spearheaded its 11th-hour inclusion during an extremely contentious federal budget negotiation process, along with Rep. Alexandra Ocasio-Cortex (D-NY).
Another noteworthy contribution to the public commentary came from Denver-based psychedelic advocate and practitioner Ashley Troxell. Troxell has been a leading voice in Colorado’s grassroots psychedelic community, and an outspoken critic of potential corporatization/pharmaceuticalization of psychedelic care after the state’s adoption of the Natural Medicine Health Act Initiative back in 2022.
Troxell called for the FDA “to recommend the descheduling of psilocybin mushrooms to the DEA, and to propose an evidence-based regulatory framework.”
In her statement, Troxell called for the FDA “to recommend the descheduling of psilocybin mushrooms to the DEA, and to propose an evidence-based regulatory framework that ensures safe, affordable access.”
Troxell also highlighted that “psilocybin has the highest safety profile of any psychedelic, and [psychedelics’] potential for treating PTSD is supported by a growing body of research.” She cited dysfunctional implementation processes in US psychedelic reform efforts as further evidence for the need for a carefully regulated descheduling process, ensuring equitable access to a regulated industry for legacy-market psychedelic professionals and caregivers.
“Oregon and Colorado’s 2025 regulatory framework for facilitation and clinical therapy present significant barriers,” she said. “These models impose excessive fees on providers, driving up the cost of sessions.” Troxell added that a recent CU Denver study “highlights that [Colorado’s] model is set to fail BIPOC communities and low-income individuals.”
While plenty of frustrations and differing opinions were aired, nobody can know exactly how things will turn out for US psychedelic access and PTSD care. What is clear is that both the federal and industry landscapes are rapidly evolving, alongside states’ laws.
Lykos Therapeutics has been restructuring in the wake of its FDA rejection: Longtime CEO Amy Emerson resigned earlier in September, following a 75 percent staff reduction and the departure of MAPS founder Dr. Rick Doblin from the Lykos board.
In August, as Filter previously reported, the Drug Enforcement Administration (DEA) scheduled a 10-day public commentary period around its longstanding attempts to classify two widely-utilized psychedelic research chemicals as Schedule I drugs.
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