Many psychedelics, including LSD, MDMA (known as “Molly”), and psilocybin, are federally banned. However, research suggests that some of these substances may help in alleviating treatment-resistant depression and PTSD, among other conditions. While the new executive order doesn’t fundamentally change the evidence on safety and efficacy the FDA would need to see, experts say it’s a symbolic act that signals the administration’s unusual openness to considering scheduled substances as potential treatments.
It has not always been easy to perform research on the medical uses of psychedelics; nor has pinning down a practical, evidence-based therapy using psychedelics. Two years ago, the FDA rejected an application to approve MDMA as a treatment for PTSD, asking for further study. Late last year, the FDA decided against granting accelerated consideration to Compass Pathways’ synthetic psilocybin treatment for severe depression, STAT reported.
Read More: There Are No Good Treatments for PTSD. MDMA Can Change That
On the other hand, is it a possibility that, with pressure from the White House, treatments might be rushed through approval that should not be? “That is a concern. That wouldn't be good for anyone,” says Marks. “It could really set back what progress has been made.”
What is ibogaine, and why did Trump mention it?
Ibogaine can cause fatal cardiac arrhythmias, however, and research on it was halted in the U.S. in the 1990s. Studies elsewhere in the world, including in Mexico, where ibogaine clinics operate, have been relatively small.
What will this executive order change?
The White House asked the FDA to direct their attention to determining what psychedelics might be given vouchers for accelerated consideration on the path to approval. The manufacturers of these substances would have the option of having their dossiers of supporting evidence examined by regulators within 1 or 2 months, rather than 6 to 12 months more typical of the FDA approval process.
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