Any 2026 psychedelic approval will carry a REMS with mandated durability and responder follow-up.

If the US drug regulator (FDA) approves a psychedelic medicine, it will almost certainly attach a special safety program called a REMS (Risk Evaluation and Mitigation Strategy). This means patients and doctors can't just get a prescription like a normal drug — there are extra steps, check-ins, and tracking requirements. The FDA wants to make sure the drug keeps working safely over time and understand why it helps some people more than others.

Functional unblinding and response heterogeneity demand post-market safeguards. I won't sign off without stratification data, regardless of advocacy pressure.