The Food and Drug Administration has unveiled multiple actions supporting President Donald Trump’s executive order fast-tracking access to psychedelic therapies for mental health conditions and substance use disorder (SUD). On July 14 the agency announced a public hearing to get feedback about potential psychedelic therapies, and simultaneously published final clinical guidance for developers preparing to submit investigational new drug applications (INDA). A day earlier, the Department of Health and Human Services and the Department of Veterans Affairs announced a collaboration in anticipation of the first INDA approvals.
“In recent years, there has been growing interest in and active research on the therapeutic potential of psychedelic drugs, in particular for the treatment of serious mental health conditions,” the FDA stated. “In response, FDA has made significant advances in psychedelic drug development through the issuance of scientific guidance, engagement with federal partners and the public, and regulatory actions to support drug development.”
A four-hour public hearing has been set for September 14 at the FDA campus in Silver Spring, Maryland. Requests to attend, either virtually or in person, must be submitted by August 21. The public can submit comment electronically up through October 5. Confidential submissions can also be sent by mail, as long as they’re received by the same deadline.
It’s likely that the first approvals of Schedule I psychedelics would be followed by proposals for rescheduling.
The clinical guidance is the final version of draft guidance the FDA issued in June 2023.
“Drug development programs for psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drug development programs,” the final guidance states. “However, designing clinical studies to evaluate the safety and effectiveness of these products presents a number of unique challenges.”
The agency went on to describe the potential for “intense perceptual disturbances and alterations in consciousness,” as well as “both rapid-onset and long-term benefits,” sometimes after only one dose.
“There is preliminary evidence that psychedelic therapies can rewire the brain and produce rapid improvements for people with serious mental illness or substance use disorders,” stated National Institutes of Health Director Dr. Jay Bhattacharya. “However, we still have much to learn about long-term benefits and risks, including the potential for misuse.”
A number of psychedelic substances have been heavily researched for their potential to treat conditions like SUD, post-traumatic stress disorder and major depressive disorder. These include psilocybin (the active compound in “magic mushrooms”) LSD, MDMA and ibogaine—all of which are banned under Schedule I of the Controlled Substances Act. Because the criteria for Schedule I are a “high potential for abuse” and no medical use approved by the FDA, it’s likely that the first INDA approvals would be followed by proposals to reschedule those psychedelics to a less-restrictive category, the same process by which medical marijuana was recently moved to Schedule III. The final clinical guidance states that in the event of a Schedule I psychedelic being approved for medical use, “the abuse potential assessment [from the INDA] would assist in determining an appropriate rescheduling action.”
HHS singled out ibogaine in particular.
The HHS announcement singled out ibogaine in particular. The plant-based psychedelic from Central West Africa appears to be in favor with the Trump administration, and the National Institute on Drug Abuse is currently funding research exploring it as a treatment for opioid use disorder.
On July 13, HHS also announced a new memorandum of understanding (MOU) with the VA. At publication time the VA was involved in 20 active clinical trials studying psychedelic treatments for mental health conditions.
“Under the agreement, HHS and VA will coordinate workforce training, develop evidence-based clinical protocols, support research and real-world evidence generation, and prepare the VA healthcare system to responsibly implement future FDA-approved rapid-acting psychiatric drug products as they become available,” the MOU states.
It will be in effect through 2031. The partnership will aim to increase veteran participation in clinical trials, train the health care workers involved in such trials, create public awareness materials and facilitate data-sharing that could allow the FDA to issue INDA approvals more quickly.
The HHS announcement also referenced a “separate, complementary MOU” pertaining to mental health treatment more broadly, but this appeared to be the same one announced by the FDA. That MOU is the only one recently listed in the FDA’s Domestic MOU catalog, although there its expiration date is “Indefinite” rather than the five-year term described elsewhere. The FDA did not respond to Filter’s inquiry.
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