04/19/2026
Lots of ways to interpret the Executive Order focused on psychedelics the President signed yesterday. Let’s approach with a rational mind from a grounded placed and break it down: ✨ ✨ ✨
The EO is pretty significant and multifaceted. It accelerates approvals for M**A, psilocybin, deuterated psilocybin, L*D d-tartrate, and S-ketamine.
✨Orders FDA/DEA to follow the Right to Try Act, even for scheduled substances (been a huge issue).
✨Orders HHS/FDA to sign data-sharing from VA to FDA/HHS so that FDA can accept clinical trial data derived from VA studies when considering drug approvals, and HHS can consider that data during drug rescheduling. One of FDA’s biggest concerns about M**A was the small amount of safety data — it’s very safe, but was only shown in only hundreds of patients. That’s the number of patients the FDA had asked to study M**A safety in, but later they rejected the NDA because different reviewers thought that was too small. Adding VA trial data would rapidly increase the size of the safety database for M**A (and for other psychedelics that VA may be studying), without having to do new studies. This may trigger rapid approvals.
✨Section 5 orders the AG/DEA to promptly reschedule any product in Schedule 1 that has “successfully completed Phase 3 clinical trials for a serious mental health disorder”. As written, this rescheduling process should happen *before* FDA approval, for products that “are ultimately approved.”
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