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Getting to Plan B for psychedelic medicine: Lessons from reproductive health

Harvard Psychedelics News · Aug 11, 2024 · Susannah Baruch
Open on statnews.com
TL;DR

Psychedelic medicine can follow an approval path similar to reproductive health care, using evidence, careful regulation, and community support to overcome stigma and restrictive laws, Susannah Baruch argues. Baruch compares the FDA decision not to approve Lykos Therapeutics' MDMA plus therapy for PTSD with the long, politically tangled route to making emergency contraception (Plan B) and mifepristone broadly available. In her view, both areas face gaps between public demand and legal restrictions, with enforcement and resource disparities hitting marginalized people harder. Drawing lessons from contraception and abortion care, Baruch emphasizes high-quality evidence of safety and effectiveness, transparency about risks, and practical access infrastructures like accurate public information, reduced medically unnecessary barriers, and confidential support. She also links upcoming psychedelic regulation to concerns raised during the MDMA review process, including adverse event reporting, research bias, and functional unblinding in trials.

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Published Aug 11, 2024 · Added Mar 6, 2026