MAPS's Message to the FDA After Last Week's Hearing: The Drugs Are Ready. The Systems Aren't.
Three days after the FDA's psychedelic-drugs hearing drew over 1,800 registrants, MAPS put its reaction on the record. Co-executive director Betty Aldworth: "The importance of therapy to these treatments cannot be understated — and it wasn't." Co-executive director Ismail Ali, J.D., was more direct: "Breakthrough clinical findings are promising, but mean little if the systems around them are not prepared to deliver them to patients." MAPS says it will submit formal written testimony to the FDA's public docket (open through Oct 5) addressing three specific gaps: systems readiness, therapist training capacity, and patient access — echoing the same provider-training and access themes the hearing itself surfaced. Separately, MAPS shared its recently published, open-science Ibogaine Investigator's Brochure directly with HHS, FDA, and the VA — a concrete document handoff, not just commentary. None of this changes the regulatory timeline on its own, but it's a marker of who's showing up to shape it: MAPS has pushed psychedelic policy since 1986 and has deployed over $150 million in philanthropic funding toward exactly this kind of infrastructure question.
Read at MAPS