FDA’s Draft Guidance for Psychedelic Research Could Pave Way for More Widespread Adoption

The FDA is looking to hammer out a new pathway for studying the use of psychedelic drugs to treat behavioral health conditions.

Specifically, the agency recently released a new draft guidance for the clinical development of psychedelic drugs.

Although psychedelic drugs have shown promise in treating various mental health and substance use disorders, researchers have faced barriers in setting up clinical studies to evaluate the substances. In turn, providers have been limited in the use of these drugs to treat patients.

These draft guidelines outline the consideration for drug development programs, clinical trials and marketing authorizations, plus safety and abuse protocols.

In the guidance, the FDA noted that psychedelic research has several nuances that must be considered.

“Some drug development programs incorporate a psychological or behavioral intervention. Investigators hypothesize that psychedelic drugs have both rapid-onset and long-term benefits after only one or a few doses,” the FDA wrote in the draft guidance. “These and other unusual characteristics should be considered when designing clinical studies so that the results of those studies can be interpretable.”

Additionally, psychedelics’ ability to cause “intense perceptual disturbances” and alter consciousness for several hours creates a notable difference from other substances, according to FDA.

While this guidance is a start, some call for the agency to do more.

“The FDA guidelines are the first step in the right direction for the organization as it recognizes that these compounds are going to make an impact on the way we think about treating a variety of mental health disorders,” Dr. Stephen N. Xenakis, executive director of the American Psychedelic Practitioners Association (APPA), wrote in an email to Behavioral Health Business. ”What the guidance doesn’t acknowledge, however, is the unique features and innovative modalities that psychedelic-assisted therapies and treatments have highlighted.”

The guidelines cover the chemistry, manufacturing and controls of psychedelics. They cover non-clinical use, clinical pharmacology and abuse protocols.

“The coming psychedelic revolution will necessitate a fundamental change in how mental health inputs and outputs are measured and therefore how we train people to deliver those therapies will also need to change,” Xenakis said. “There is also a large section in the document that focuses on abuse potential and harm of the medicines, [which] we fear is an unfounded bias against these compounds that could be a holdover from the War on Drugs.”

Industry stakeholders have until Aug. 25 to submit feedback on the new guidelines.

In the future, the APPA is also encouraging other agencies to get involved.

Another possible consideration should be the U.S. Department of Health and Human Services (HHS) developing a public-private partnership (P3) text for draft recommendations, Xenakis said.

“For the past 20 years, HHS has sponsored P3s for complex issues like this one,” he continued.

The FDA isn’t the only organization looking to update its psychedelics consideration.

The American Medical Association released its new CPT code for psychedelic therapies in May.

Despite national interest in psychedelics for behavioral health, it has been a bumpy year for the sector as a whole.

Ketamine-assisted therapy provider Field Trip sold for parts after experiencing financial troubles earlier this year. Additionally, Ketamine Wellness Centers, which claimed to be the largest ketamine provider in the country, closed its operations in nine states and appears to be on the market.

Companies featured in this article:
American Psychedelic Practitioners Association

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