FDA Releases First-Ever Draft Guidance For Psychedelics Research, Days After Congressional Lawmakers File Bill Asking For It

The Food and Drug Administration (FDA) has released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.

Two days after bipartisan congressional lawmakers filed a bill to direct the issuance of such guidance, FDA published a 14-page draft document that appears to be responsive, providing scientists with a framework to carry out research that could lead to the development of psychedelic medicines.

A notice about the move is set to be published in the Federal Register on Monday. At that point, a 60-day public comment period will open for interested parties to submit feedback on how final guidance should be shaped.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release on Friday. “Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges,” she said. “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

Interest in psychedelics has grown exponentially over recent years as cities and states across the country have moved to promote research, remove criminal penalties and regulate access to substances such as psilocybin and MDMA—both of which have already been designated by FDA as “breakthrough therapies.”

The agency’s draft guidance “describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements,” it said.

One factor that FDA said was important to note is the fact that many psychedelics produce psychoactive effects that could give them higher abuse potential. Also, entheogenic plants and fungi like psilocybin are Schedule I drugs under the Controlled Substances Act (CSA), requiring researchers to go through a more complex registration process with the Drug Enforcement Administration (DEA) in order to obtain them for study purposes.

“The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled,” FDA said. “The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.”

With respect to psychedelics in psychotherapy, that’s also the focus of a bill filed by Reps. Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) on Wednesday.

The legislation calls on the secretary of the U.S. Department of Health and Human Services (HHS), acting through the FDA commissioner, to “issue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration.”

If enacted, it would have required FDA to produce that draft guidance within 180 days. But the agency was evidently prepared to release it much sooner. The bill would also mandate FDA to finalize its guidance 180 days after the draft document’s publication, so lawmakers may still be interested in advancing the measure with that provision.

On the same day that the legislation was introduced, Crenshaw discussed it at a House Energy & Commerce Committee hearing, where he talked about psychedelics as one possible “solution” to the country’s substance misuse issues.

The congressman said that he was working on “getting clinical trial guidance for psychedelic therapies from the FDA,” adding that “this therapy will be earth-shattering. It already has been already changed dozens of lives.”

“We’re not talking about 1960s LSD trips. This therapy is supervised by a medical practitioner [and] often occurs with repeat treatments in a controlled setting,” he said. “And when it comes to the efficacy of this therapy, the proof is in the data, in the testimonies—but we need the FDA to issue clinical trial guidance for psychedelic assisted therapy so that the the industry can actually invest in this.”

“Right now, it’s difficult for researchers to pursue these trials without any direction at all from FDA,” Crenshaw said. “Without that direction, it’s even more difficult for us to conduct the research to tap into this breakthrough treatment option.”

The draft FDA guidance released on Friday notes that many psychedelics that are being developed with the intent of having them administered “while the subject is experiencing the acute effects of the drug or in a subsequent session.”

“This additional variable both complicates the assessment of effectiveness and presents a challenge for any future product labeling,” FDA said.

The agency advised, for example, that the “therapist monitoring the session can usually deduce the treatment assignment by observing the subject’s behavior,” so “it is preferable that the in-session monitor is not involved in post-session psychotherapy because their knowledge of the treatment could bias the delivery of subsequent therapy.”

FDA emphasized that after the guidance is finalized it will simply represent the agency’s “current thinking…on this topic.”

“It does not establish any rights for any person and is not binding on FDA or the public,” it told researchers. “You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

The FDA’s Federal Register filing notes that a public docket will be made available for people to submit comments on the draft guidance.

The move is timely, as lawmakers and health officials have shown serious interest in quickly expanding research into psychedelics as studies have revealed their potential in the treatment of conditions such as severe depression, post-traumatic stress disorder and addiction.

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