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.