The Food and Drug Administration hosted a hearing on Monday on psychedelic therapy, with the agency and other federal partners taking testimony from dozens of advocates, researchers and industry participants. Eighty invited witnesses were given two minutes each to summarize their stances and flag issues for federal officials.
FDA Holds Hearing on Psychedelic Therapy, Takes Testimony From 80 Invited Witnesses
The Food and Drug Administration hosted a hearing on Monday on psychedelic therapy, with the agency and other federal partners taking testimony from dozens of advocates, researchers and industry participants. Eighty invited witnesses were given two minutes each to summarize their stances and flag issues for federal officials.
Before testimony began, Marta Sokolowska, deputy director for substance use and behavioral health at the FDA's Center for Drug Evaluation and Research, said the hearing was "part of a whole of government effort to better understand the opportunities, challenges and public health considerations associated with this evolving area of psychedelic drug treatment." She said there had been growing interest and active research on the therapeutic potential of psychedelic drugs, particularly for treatment of serious mental health conditions, and that more than 1,800 people had registered for the hearing as of the weekend.
Sokolowska said the FDA has taken "a number of steps to advance psychedelic drug development" in recent years, including publishing guidance for researchers, partnering with other agencies and taking regulatory actions. She said recent actions were intended to support an executive order President Donald Trump signed earlier this year to streamline research and access into psychedelic medicine. "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," she said. "FDA remains committed to supporting innovation while maintaining rigorous scientific and regulatory standards, and for the evaluation of drug safety, effectiveness and quality."
Sokolowska said the FDA in April issued national priority vouchers to three companies studying psilocybin for treatment-resistant depression and major depressive disorder, as well as methylone (MDMC) for post-traumatic stress disorder (PTSD), and allowed an early phase clinical study of an ibogaine derivative to proceed with an Investigational New Drug (IND) submission. She also said the FDA signed a memorandum of understanding with the Department of Veterans Affairs to collaborate on research and development of psychedelic medicines for people with serious mental health conditions. She noted that last week FDA officials authored a paper in the New England Journal of Medicine laying out the agency's "new framework" for psychedelic medicines, including steps to "make psychedelic therapies available to patients more quickly, as warranted by the nation's mental health crisis."
Dayle Cristinzio, director of public engagement at the FDA, said the hearing was "not intended for the promotion of any specific drug or commercial product" and was focused on gathering information and perspectives "that may help inform continued work in this area for FDA and our federal partners." She said the agency heard perspectives on provider training and credentialing, promotion of patient safety, considerations for access, best practices for data collection and standardization, and a range of related considerations. She said people can submit comments to an FDA docket about psychedelics through October 5.
Other agencies that participated in Monday's hearing include the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, the Veterans Health Administration and the Advanced Research Projects Agency for Health. HHS Secretary Robert F. Kennedy Jr. said in a podcast released the week before the hearing that he believes there will be an "enormous demand" for psychedelic therapies as they become legally available, and he thinks Trump is unique among his predecessors in championing the issue. In April, the FDA and HHS announced steps that they said would help with "accelerating" therapeutic access to psychedelics for patients dealing with serious mental health conditions.
In the month before the hearing, the Substance Abuse and Mental Health Services Administration issued a report on recent advances in psychedelic medicine, along with recommendations for state policymakers on how to prepare for formal approval of drugs like psilocybin and MDMA. It noted that the Schedule I status of many psychedelics has hampered scientific studies on their effects for decades. In May, a bipartisan coalition of 32 members of Congress sent a letter urging the FDA to expedite ongoing reviews of psychedelic therapies. Lawmakers recently filed a bill that would require the Department of Defense to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military. A separate recently introduced bipartisan measure is intended to codify Trump's psychedelics executive order into law. An amendment adopted as part of the National Defense Authorization Act would extend a psychedelics research effort at the Department of Defense for an additional six years.
- The source does not state the exact date of the hearing beyond Monday.
- The source does not state how many of the 80 invited witnesses actually testified.
- The source does not name the three companies that received national priority vouchers.
- The source does not state the specific provisions or date of the executive order Trump signed.
- The source does not include the positions of the advocates, researchers and industry participants who testified, beyond that they summarized stances and flagged issues.
- The source does not state whether the FDA responded to the May letter from the 32 members of Congress.
- The source does not state the Department of Defense's position on the proposed psilocybin research bill or the National Defense Authorization Act amendment.
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