MDMA-assisted therapy for trauma (PTSD) already got rejected once by the FDA and is going through a second review — but regulators say they still need better evidence before they'll approve it. Specifically, they want researchers to solve two problems: participants in trials can easily tell whether they got the real drug, which can skew results, and the long-term effects aren't well enough documented. Political pressure won't speed this up.
My division requires resolved functional-unblinding and durability data before approval. Nothing today changes the evidentiary bar. Political noise doesn't move review timelines.
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