Optimizing real-world benefit and risk of new psychedelic medications: the need for innovative postmarket surveillance

Introduction

Psychedelic drugs constitute a chemically heterogeneous group that alter behaviour, mood, thought and perception; the term is used in this Perspective to encompass serotonergic, entactogenic and dissociative substances. Black and colleagues note that while some compounds have long historical use and others are newly developed by industry or illicit synthesis, regulatory classifications (for example US Schedule 1) have been shifting alongside a growing international research effort. Late-stage clinical trials have reported positive results for indications such as major depressive disorder, treatment-resistant depression (psilocybin) and post-traumatic stress disorder (MDMA), and an MDMA new drug application has been submitted to the US FDA, but the FDA has issued draft trial guidance without parallel guidance for postmarket surveillance. This paper sets out to define the surveillance needs specific to psychedelic medications as they move into real-world clinical use. The authors argue that existing surveillance systems are poorly matched to the distinctive pharmacology, care models and socio-environmental influences surrounding psychedelic-assisted psychotherapy, and they propose a purpose-built, multi-component ‘‘mosaic’’ of data systems and measurement approaches to monitor real-world effectiveness, safety and equitable access.