FDA Nears Psychedelic Drug Approval; ‘Who Will Administer and Monitor Treatment?’ Is Key Question

The U.S. Food and Drug Administration (FDA) held a public hearing on the 15th (local time) to gather input on how psychedelic drugs would be used and monitored in practice ahead of the agency’s first approval of a psychedelic drug, Fierce Biotech reported.

Access was the hearing’s central issue. If psychedelic drugs are approved, attention will focus on whom the FDA allows to administer them and how that decision could affect patients’ access to treatment in practice.

Biotechnology companies currently developing psychedelics have adopted a supervised treatment model in which health care professionals participate as “dosing session monitors” (DSMs), rather than using the approach of adjunctive psychotherapy employed in states such as Oregon and Colorado. Compass Pathways and Definium Therapeutics are among the companies using this model.

However, many hearing participants urged the FDA to recognize psychotherapy’s role. Clinical psychologist Jeff Bash said, “I was disappointed to see the importance of the therapeutic relationship minimized in order to isolate the drug’s effects in clinical trials.”

Bash said, “There are a small number of clinical trials comparing ketamine and other psychedelics with and without therapy, but so far, the results have shown that they are more effective when therapy is included.” He added, “Sacrificing the therapeutic relationship to reduce costs is a mistake.”

Definium Therapeutics announced its third successful phase 3 clinical trial in 12 weeks, while Compass Pathways is submitting new drug applications sequentially after two pivotal trial successes related to depression.

Even if the FDA allows DSMs to participate instead of therapists, how to train and credential them remains unresolved. Psychiatrist Rajan Dunn argued, “Psychedelics used to treat mental illness require clinical oversight by a psychiatrist.”

Operators of education and credentialing services called for developing a workforce and establishing training standards for psychedelic treatment. Palliative care physician Lida Fatemi said, “Safe delivery requires prepared people and communities, not prescribing authority.”

By contrast, nurse practitioner Tina Braddock said, “There is no need to create a new workforce,” adding, “Nurses are already licensed and trained and can be deployed immediately.”

Access concerns were further highlighted when the FDA’s guidance in July stated that “if the primary monitor is not a physician, an on-call physician must be able to reach the patient within 15 minutes.”

John Dalton, president of the Nevada Psychedelic Medicine Coalition, said, “In western states such as Nevada, this requirement could exclude care at qualified clinics.” He urged the FDA to “maintain the nonphysician primary monitor model and not apply a uniform 15-minute standard.”

Meanwhile, Kevin Sabet, a former White House drug policy adviser, said, “Psychedelics should be approved through science and clinical trials, not politics or podcasters.” His comments followed President Donald Trump’s interest in psychedelics after podcaster Joe Rogan’s visit to the White House.

President Trump signed an executive order on April 18, and the FDA soon afterward issued priority review vouchers to three developers, including Compass Pathways.

Sabet said, “There is a rush to commercialize these substances on a large scale before the science is sufficiently supportive,” expressing concern that phase 3 clinical trials have small sample sizes and methodological problems.

Other safety concerns raised at the hearing included sexual misconduct by health care professionals and cardiac risks associated with psychedelic use. Susan Tamer Saggi, co-founder of a nonprofit organization, said, “My 21-year-old daughter, Shira, died after using psychedelics.”

Saggi said, “FDA approval would have enormous societal implications,” emphasizing the importance of screening patients’ health before treatment and providing effective oversight.