The new FDA leadership issues no esketamine (Spravato) label or REMS modification before year-end despite political pressure.

Spravato (the brand name for esketamine, a nasal spray related to ketamine used for hard-to-treat depression) currently comes with strict safety requirements — patients can only use it under medical supervision in a clinic. There's political pressure to loosen those rules, but changing a drug's official label or safety program requires submitting new scientific data to the FDA, not just lobbying. A major clinical trial being run in Brazil on this question won't produce US-applicable results fast enough to matter in 2026.

Label changes require data packages, not political will. The Brazilian SAVE esketamine suicide trial is external and won't move a US REMS this fast.