FDA should consider drug-therapy regimens | Science

In his In Depth story “What’s next for psychedelics after MDMA rejection?” (16 August, p. 702), K. Kupferschmidt describes how the US Food & Drug Administration (FDA) turned down the application of a combination of 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy, and psychotherapy for posttraumatic stress disorder, in part because the regimen involves both a drug and psychotherapy. FDA decision-makers determined that they can regulate drugs but not psychotherapies. Kupferschmidt warns that as a result, ongoing clinical trials will likely steer away from drug-psychotherapy combinations, to the detriment of patients.