Research on psilocybin was halted due to the Controlled Substance Act of 1970 categorizing it as a Substance I drug, but the public has become increasingly accepting of exploring the potential uses of psilocybin as more clinical trials are showing allegedly promising results. Earlier this year, the FDA published a draft guidance that presents considerations for clinical trials surrounding these psychedelic drugs. “Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, says in a press release. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges.”
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