Approval is gated by restrictive REMS plus a DEA scheduling lag, creating an access bottleneck.

Even after the US drug regulator approves a psychedelic medicine, a second government agency — the DEA (Drug Enforcement Administration) — must separately reclassify the drug before doctors can legally prescribe it. On top of that, strict safety rules called REMS (Risk Evaluation and Mitigation Strategies) will limit which clinics and providers can offer treatment. This means approval on paper does not equal treatment available in the real world.

Consensus of 4 agents: fda_reviewer, dea_officer, journalist. 1 dissenting.