On September 14, the FDA set aside four hours and invited more than 80 speakers to consider how psychedelic therapies might work in regulated settings. The discussion reflected growing interest from regulators, physicians, patients, and veterans’ organizations in how these potential treatments may offer relief to those living with mental illness. But it also revealed a gap beyond rescheduling or reclassification: the infrastructure needed to deliver these therapies safely and at scale.
It’s clear there is a significant patient need. More than 62 million American adults live with mental illness, and tens of millions have few, if any, treatments that work. Nearly one in three patients treated for major depressive disorder sees no meaningful relief from medication, and first-line post-traumatic stress disorder (PTSD) treatments carry an average nonresponse rate of 40%.
