Comment from Randall Simpson

**Comment on Docket No. FDA-2026-N-7542** Thank you for the opportunity to comment on the FDA's public hearing regarding the potential future therapeutic use of psychedelic drug products. My comments relate primarily to provider training, patient safety, informed consent, and the importance of precise communication. **1. Precision in Terminology** The term *psychedelic* has become increasingly imprecise in public discourse. Clinical evidence is developed for specific substances, formulations, doses, indications, and patient populations, yet public communications often refer broadly to "psychedelics" as though they constitute a single therapeutic category. This has contributed to public misunderstanding. Evidence supporting one substance is frequently perceived as applying to chemically and pharmacologically distinct substances with different histories, mechanisms, and risk profiles. I encourage the FDA to require that communications associated with regulated psychedelic drug products clearly identify the specific substance being discussed. Claims regarding safety, efficacy, adverse events, or clinical evidence should be attributed to the individual substance and approved indication rather than generalized to "psychedelics" as a whole. Precision in language is an important component of informed consent and patient safety. **2. Provider Training and the Limits of Professional Authority** Provider training should emphasize the limits of the facilitator's role. These experiences often produce insights that participants regard as deeply meaningful and personally significant. Because of the heightened suggestibility that can accompany these states, providers should exercise particular caution in avoiding undue influence. Training should emphasize psychological and physical safety, ethical boundaries, and non-directive support rather than encouraging providers to assume interpretive authority over a participant's experience. Providers should avoid leading participants toward predetermined psychological, ideological, or spiritual conclusions or implying that they possess unique expertise in interpreting another person's subjective experience. Humility regarding the limits of professional knowledge is itself an important patient safety measure. **3. Patient Safety and Informed Consent** Informed consent should accurately communicate that the subjective effects of these substances can be profound and may lead participants to reconsider long-held beliefs, relationships, priorities, or life decisions. Because these experiences may substantially influence judgment, providers should be trained to minimize suggestion and to distinguish between supporting a participant's process and directing it. Participants should understand the facilitator's role before treatment begins so they can make informed decisions about the degree of guidance they wish to receive. **4. Scope of FDA Communications** Finally, I encourage the FDA to maintain clear distinctions between therapeutic drug products under FDA review and broader categories of substances or practices that fall outside the agency's statutory authority. Doing so will improve public understanding of what the available evidence does and does not support, while reducing confusion created by the increasingly broad use of the term "psychedelic." Thank you for considering these comments.