Any MDMA approval will carry a REMS with confirmatory-trial postmarketing requirements rather than clean approval.

If the FDA approves MDMA, it will come with a tight rulebook called a REMS (Risk Evaluation and Mitigation Strategy) — a set of safety guardrails that controls exactly who can prescribe it, where, and how. On top of that, drug makers will have to run more clinical trials after approval to keep proving it works and is safe. This is not unusual for risky drugs, but it means MDMA therapy won't spread quickly or cheaply even after approval.

Functional unblinding and abuse-potential concerns mandate risk mitigation. My division never grants psychiatric Schedule I drugs unconditional approval. Patient protection demands controlled rollout.