Psilocybin is a naturally occurring compound found in over 200 species of mushroom and is currently regulated as a Schedule I drug with "no currently accepted medical use and a high potential for abuse" pursuant to the federal Controlled Substances Act (CSA). Notwithstanding that classification and description, a growing body of scientific and medical studies and trials indicates that psilocybin-assisted therapies provide benefits to those suffering from various health conditions. In fact, the U.S. Food and Drug Administration (FDA) itself has twice designated psilocybin as a "breakthrough therapy," meaning clinical evidence indicates that psilocybin therapy demonstrates substantial improvement over other available therapies for both major depressive disorder and treatment-resistant depression.  

Given these findings, an increasing number of foreign and domestic stakeholders continue to act and advocate for expanded access to psilocybin therapies. For example, Australia's equivalent to the FDA announced that medicines containing psilocybin can be prescribed for the treatment of certain mental health conditions starting July 2023, and Oregon recently began accepting applications for psilocybin business licensure. Litigation is another pathway being used to facilitate psilocybin access. In a leading U.S. case, Aggarwal v. U.S. Drug Enforcement Administration, No. 22-1718 (9th Circuit), petitioner Dr. Sunil Aggarwal seeks to secure access to psilocybin for administration to his patients by compelling the U.S. Drug Enforcement Administration (DEA) to follow protocol and properly consider rescheduling psilocybin from Schedule I to Schedule II of the CSA.