Sam Harris (Making Sense)

Is Psychedelic Therapy Ready for FDA Approval?

The conversation with UCSF neuroscientist Robin Carhart‑Harris examines whether psychedelic‑assisted therapies are poised for FDA approval. He frames the treatment as a combination of a drug that opens a "plastic" mental state and a carefully managed therapeutic context that must shape that plasticity. Carhart‑Harris describes a field that rode a hype wave after Michael Pollan’s bestseller, then suffered a market correction when MAPS’s MDMA‑for‑PTSD application was rejected. Despite the setback, publication rates have surged, with dozens of small trials and a handful of larger phase‑2/3 studies—most notably Compass Pathways’ psilocybin program for treatment‑resistant depression—pushing the evidence base toward regulatory readiness. Key examples illustrate the nuance: he likens music to a "hidden therapist," and stresses that set (mindset) and setting (environment) are integral to outcomes. He also recounts a troubling case where a therapist’s strong belief in recovered memories may have steered a patient’s experience, underscoring the need for strict therapist training and bias mitigation. The implications are clear: FDA approval will depend not only on drug safety and efficacy data but also on standardized, high‑quality therapeutic protocols. Investors, clinicians, and policymakers must watch how the industry addresses context control and ethical safeguards, as these factors will shape the next wave of psychedelic medicine commercialization.