By Josh Bauchner –
Maligned, stigmatized, and marginalized for decades, psychedelic drugs have long been off-limits for researchers and others who wanted to explore the potential therapeutic uses of these substances for various conditions, including PTSD, depression, substance abuse, and anxiety. Now, in a significant step that offers the promise of new medical treatments and advancements, the U.S. Food and Drug Administration (FDA) issued its first-ever guidance for those wishing to study and test psychedelics for medicinal use.
Released on June 23, 2023, the FDA’s draft guidance contains non-binding recommendations for designing clinical trials for psychedelic drugs. According to the FDA, the draft guidance aims to “advise researchers on study design and other considerations as they develop medications that contain psychedelics.” As used within the guidance, the term “psychedelics” refers to “‘classic psychedelics,’ typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, as well as ‘entactogens’ or ’empathogens’ such as methylenedioxymethamphetamine (MDMA).”
The guidance discusses basic considerations throughout the drug development lifecycle, including trial conduct, data collection, participant safety, and new drug application requirements. Emphasizing psychedelics’ potential for abuse and psychoactive effects such as hallucinations and mood and cognitive changes, the FDA notes that this creates “a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.” This includes addressing potential interactions with drugs like antidepressants or lithium and “the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.”
Outlining the needed steps for psychedelic drug testing and study, the FDA provides recommendations for nonclinical safety and toxicology studies, with examples of when extensive previous trial data could substitute typical animal toxicology testing in trials under an Investigational New Drug Application (INDA). The guidance notes that since psychedelics are Schedule I controlled substances, activities associated with investigations under an INDA must comply with applicable Drug Enforcement Administration regulations.
The FDA released its guidance days after legislation was introduced in Congress with bipartisan support directing the agency to do so. While it is unclear what the guidance will look like in its final form after the 60-day public comment period, the legislative and regulatory movement to allow for more research and testing of psychedelics for therapeutic use is a positive development for individuals seeking relief from a wide range of debilitating conditions.
If you have questions or concerns about the FDA’s draft guidance, please contact an attorney in Ansell.Law’s Controlled Substances and Regulatory Law Practice Group.
