FDA issues no psilocybin approval in 2026; any MDMA action requires additional confirmatory data or REMS conditions.

The FDA will not give psilocybin the green light as a medicine in 2026. For MDMA, the FDA already raised serious concerns after reviewing trial data — patients and therapists both knew who got the real drug, which may have skewed results. Before any approval, the FDA wants stronger, cleaner evidence that the treatment actually works.

Functional-unblinding and durability concerns remain unresolved. My job is patient protection, not hype response. Broad-indication efficacy signals raise placebo-expectancy flags I must rule out.