FDA hearing shifts the psychedelic approval debate toward who must deliver treatment and what training, oversight, and safety infrastructure are required

The FDA's September 14 public hearing exposed a fundamental disagreement over who must be present when an approved psychedelic is administered. Psychiatrist Rajan Dunne argued that psychiatric treatment should require psychiatrist oversight, while other speakers supported interdisciplinary teams involving nurses and therapists, trained non-physician facilitators, or state-licensed providers. Testimony also distinguished FDA-regulated supervision during acute drug effects from psychotherapy, preparation, integration, and informed consent, which involve separate competencies and state scope-of-practice rules. Lisa Ginzburg cited an Oregon cohort of 346 participants across 24 service centers, where four serious behavioral reactions were identified but only one was recognized as serious in real time, supporting both acute monitoring and longer-term surveillance. FDA panelists asked none of the twenty speakers questions and stated no preferred model, so the hearing reveals stakeholder positions rather than agency policy. The unresolved framework could affect access, costs, workforce supply, state licensing, and commercial rollout timelines for psilocybin and methylone programs.