The Food and Drug Administration recently offered a glimpse into its comprehensive analysis justifying its recommendation to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act.
CDER director Patrizia Cavazzoni explained that as part of the FDA’s “directive to explore whether marijuana should remain listed as Schedule 1 under the Controlled Substances Act,” the FDA conducted “an expansive review of numerous data sources.”
The 2023 fiscal year Drug Safety Priorities report reveals a multi-pronged approach employed by the FDA’s Center for Drug Evaluation and Research (CDER). At the core was an eight-factor analysis (8FA) drawing upon “numerous data sources,” as stated in the report, noted Marijuana Moment. However, their methods extended beyond traditional research, delving into the lived experiences of cannabis users themselves.
“As part of CDER’s cross-center evaluation of marijuana,” the report details, “the CDER Office of Surveillance and Epidemiology (OSE) completed a review of epidemiologic and pharmacovigilance data sources to inform the 8FA provided to DEA.” This scientific evaluation was accompanied by a unique social listening initiative.
For six months, a team of social scientists immersed themselves in “a detailed qualitative analysis of online and social media conversations occurring about marijuana,” states the report. Their approach involved “manually analyzing hundreds of posts on publicly…
