FDA suggests regulatory flexibility for assessing psychedelic therapies

US Food and Drug Administration regulators expressed openness to innovative approaches for evaluating psychedelic therapies in the New England Journal of Medicine. This regulatory flexibility includes considering study designs with comparators other than placebos, alongside changes to how these compounds are administered and monitored. The shift addresses a US mental health crisis where major depressive disorder and post-traumatic stress disorder are leading causes of disability.

FDA regulatory flexibility for psychedelics

• ▪The US Food and Drug Administration will consider innovative new ways to evaluate psychedelic compounds for treating mental illness
• ▪Regulators from the US Food and Drug Administration published a perspective on evaluating psychedelic therapies in the New England Journal of Medicine

Mental health treatment crisis

• ▪The ongoing mental health crisis in the United States makes it essential to find alternative treatment options for patients who do not respond to existing medications
• ▪Major depressive disorder and post-traumatic stress disorder represent leading causes of disability and premature death in the United States

Psychedelic therapy study design approaches

• ▪US Food and Drug Administration regulators indicated that evaluating psychedelics may involve changes in how these compounds are studied, administered, and monitored long-term
• ▪US Food and Drug Administration regulators expressed openness to using comparators other than placebos when studying the effects of psychedelic therapies

Debatable claims

• ▪The FDA should allow non-placebo comparators in psychedelic clinical trials
• ▪The FDA should mandate long-term monitoring for approved psychedelic therapies