Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty.

Psychedelic medicines show potential for treating serious mental health conditions, creating demand before FDA approval. Policymakers should balance evidence, patient safety, and speed by increasing research support, avoiding barriers to research, improving FDA's pre-approval access, and preventing politically driven approvals.

Study at a glance

Abstract

Psychedelic medicines hold the promise of therapeutic benefit for many suffering from serious unmet mental health needs, leading to substantial demand even before these drugs receive FDA approval based on demonstrated safety and effectiveness for particular conditions. Recognizing FDA approval as the ideal path for psychedelics intended for medical use and drawing on lessons from medical marijuana, we encourage policymakers to balance the need for evidence, the importance of patient safeguards, and the desire for speed. They should increase support for psychedelic research, reject approaches that could inhibit that research, explore improvements to FDA's existing pre-approval access pathway, and avoid politically motivated FDA approval of psychedelic medicines.