It has been six days since President Donald Trump signed an executive order aimed at facilitating regulatory review of psychedelics that have shown potential as psychotherapeutic catalysts. As promised then, the Food and Drug Administration (FDA) today issued "national priority vouchers" for two psychedelics: psilocybin as a treatment for depression and methylone (a.k.a. MDMC) as a treatment for post-traumatic stress disorder (PTSD).
The FDA had previously designated both drugs as "breakthrough" therapies, meaning they "may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints." Although that designation is supposed to streamline the review process, the vouchers go further, promising an "ultra-fast timeline" of one to two months, rather than six months or more, after the requisite studies are completed.
