Reframing psychedelic regulation: Tools, not treatments

Current regulation frameworks for medicines struggle to address the combination of pharmacological and psychotherapeutic elements in psychedelic therapy. We propose a more appropriate and advantageous approach may be to regulate psychedelic drugs as therapeutic tools or adjuncts to psychotherapy, rather than as treatments for specific mental disorders. Drawing parallels with anesthetics, which facilitate various medical procedures (through inducing a loss of sensation or consciousness) while not being treatments in themselves, we argue that a primary medical purpose of psychedelic drugs is to facilitate psychotherapeutic treatments. Reframing psychedelic regulation to accommodate this use would allow drug regulators to focus on relevant acute drug effects, rather than therapeutic outcomes that result from complex interactions between these effects and psychotherapeutic interventions; more appropriate authorities could then regulate the psychotherapy. This approach could limit the emerging trend in psychedelic drug development that views psychotherapy as a strategic liability and seeks to de-emphasize or remove it to the potential detriment of safe and durable clinical outcomes.