A Strategy for Rescheduling Psilocybin
Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a stream. But despite increasing acceptance by the public, and commercial investment in psychedelic therapies, aging federal laws stem the flow of vital research.
Psilocybin, a compound produced by many species of fungi, is one of the most well-studied psychedelics. To acknowledge its impressive safety record and potential for treating depression more effectively than existing therapies, the Food and Drug Administration designated psilocybin a breakthrough therapy in 2018 and 2019 for treating drug-resistant depression and major depressive disorder.
Despite these developments, most psilocybin research is still conducted overseas, and FDA approval remains years away. Psilocybin’s federal status as a Schedule I controlled substance is to blame. Despite overwhelming evidence that psilocybin is misclassified, this barrier restricts research, stifles competition and innovation, and inhibits access. Amid a worsening mental health crisis, the dam preventing scientific progress must be broken.
For two decades, U.S. suicide rates have steadily increased, and drug overdose rates have skyrocketed. The COVID-19 pandemic made things worse. Since 2019, anxiety rates tripled, and overdose rates surged. Meanwhile, innovation in mental health care has stagnated. Most new drugs for