Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines
Neuropharmacology August 13, 2022 Ingrid Donato, Veronica Magar, Sean J. Belouin et al. 49 citations
Psychedelic and entactogen medicines like psilocybin and MDMA, when combined with psychosocial support, show potential for safe, rapid, and durable clinical improvements. Both have received Breakthrough Therapy designation from the US FDA and may gain full approval, with similar regulatory steps in other countries. Regulatory changes are also increasing access to legal or decriminalized psychedelic use outside medical settings. This review covers historical use, current evidence, and policy considerations around standards of practice, consumer protection, community engagement, equitable access, and data standards. It suggests a public-private partnership involving diverse stakeholders to co-create best practices and public policies supporting responsible, ethical use.