Pressing regulatory challenges for psychedelic medicine

Over the past decade, research on potential therapeutic benefits of psychedelics has demonstrated promise and generated enthusiasm. The number of psychedelic clinical trials has grown dramatically, and there has been considerable private investment and regulatory interest in psychedelic drug development around the world. But this is a complicated moment for regulators seeking to impose a traditional regime of clinical trials and pharmaceutical premarket approval to a class of drugs already used outside the medical establishment through a patchwork of state and local regulation, Indigenous use, and “underground” consumption. It is difficult to anticipate how these approaches will intersect given the challenges of studying illicit use. Meanwhile, pressure from investors and public expectations may exceed the current reality of limited evidence regarding the clinical benefit of psychedelics. Against this backdrop, we focus on pressing regulatory issues that demand attention, creativity, and collaboration to maximize psychedelics’ therapeutic potential