Encourage FDA review of psychedelics

The FDA’s thorough process for evaluating clinical data of potential medications prior to approval is essential to ensuring that FDA-approved medications are both effective and safe. Increased use of psychedelics like psilocybin or methylenedioxymethamphetamine (MDMA) in an attempt to treat mental health and substance use disorders (MH/SUDs) without such a thorough evaluation by the FDA could have deeply harmful effects, subjecting individuals to MH/SUD to medications that are not therapeutic and/or could threaten their health and safety. The FDA has already granted both psilocybin and MDMA “breakthrough therapy status,” which will facilitate FDA guidance on clinical trials and expedited reviews after completed Phase III studies.[1]

The American Psychiatric Association’s position statement on the use of psychedelics notes that there is promising preliminary research on psychedelics “for the treatment of serious and disabling conditions such as treatment-resistant depression and posttraumatic stress disorder….”[2] However, the position statement notes that the use of psychedelics is “investigational” and that they have not been fully reviewed for safety and efficacy.

Such rigor is not only important to ensure the safety and efficacy of medications, but also to ensure the health care system reimburses for demonstrated safe and effective therapeutics. Health insurance will, appropriately, refuse to reimburse for medications that have not been demonstrated by the FDA to be safe and effective.

One area where adjustments may be needed is to the standard FDA process for “maintenance of effect” studies. Such studies are important for oral or injectable medications that are taken for chronic conditions on a regular basis. However, these studies likely do not make sense for substances like psychedelics, which may only have two or three doses for an entire course of treatment (paired with integrative therapy). While long-term follow-up is essential, the FDA should ensure that trials designed for older generations of medications do not inhibit evaluation of potentially paradigm-shifting medication/psychotherapy treatments.