The Food and Drug Administration (FDA) has issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September.
“In recent years, interest in the therapeutic potential of psychedelic drugs has been increasing,” the FDA document published on Monday says.
“Drug development programs for psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drug development programs,” the agency wrote. “However, designing clinical studies to evaluate the safety and effectiveness of these products presents a number of unique challenges.”
Psychedelics can “cause intense perceptual disturbances and alterations in consciousness that can last for several hours or days,” and can “have both rapid-onset and long-term benefits after only one or a few doses,” FDA said.
The guidance—titled “Psychedelic Drugs: Considerations for Clinical Investigations”—notes that psychedelics are an “an emerging area of drug development” and provides considerations that sponsors of research on substances like psilocybin, LSD and MDMA should take into account.
Among other areas, FDA is providing recommendations on how psychedelic studies handle issues such as chemistry, manufacturing, abuse potential and clinical pharmacology.
It notes that designing well-controlled studies on psychedelics can be particularly challenging due to the “often intense perceptual changes induced by the drugs.”
“This increases the potential for bias due to functional unblinding of patients, therapists, monitors, or raters,” the FDA document says. “Functional unblinding can lead to expectation bias in the patients who experience perceptual disturbances, or in those who observe them, which may lead to an expectation that the participant will experience clinical benefit; alternatively, those who receive a placebo and do not experience or observe a perceptual change may expect that the participant will not benefit.”
The final guidance builds on a draft version that FDA initially published in 2023 and comes months after President Donald Trump issued an executive order aimed at expanding and expediting research on the potential therapeutic benefits of psychedelics.
The agency said it took into account comments received in response to the draft version, and it is also accepting additional public feedback on the final document, FDA said in a Federal Register notice.
Meanwhile, FDA on Monday also announced that it will hold a public hearing on September 14 to “obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.”
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