Commenters press FDA to require common data elements and a national registry for psychedelic therapies

A recurring theme at the hearing was the need for standardized data collection and national registries to make post‑approval safety and effectiveness evidence comparable across sponsors and settings.

Multiple presenters—including Maksim Tsvetovat, Shanetha Lewis and Amber Barnato—urged the FDA to require common data elements that capture dose, formulation, setting, reason for use and standardized outcome measures so that registries and state programs can interoperate. Shanetha Lewis summarized Maryland’s consensus recommendations for interoperable data elements, saying common elements should link outcomes, access and cost measures to public-health datasets.

Justice Leak highlighted environmental and physiological variables, arguing "THE SETTING IS THE LARGEST UNMEASURED VARIABLE," and urged the inclusion of room and contextual data. Commenters proposed a national registry tied to post‑marketing tools, with pre-specified review points to relax or tighten safeguard requirements as evidence accumulates.