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 available online/social media platforms.”

This unprecedented step sought to capture “context directly from users regarding marijuana, including its effectiveness for several therapeutic purposes such as anorexia, anxiety, nausea, and pain; nonmedical purposes; benefits and negative effects, experiences with access,” the report highlights.

Beyond Research, Ongoing Struggle For Legalization

While the FDA submitted its recommendation to reschedule cannabis to the DEA in August 2023, a definitive decision remains elusive. Lawmakers like Rep. Earl Blumenauer (D-Ore.) recently sent a letter to the DEA’s Anne Milgram, pushing for more transparency and action on cannabis reform. He urged ‘full descheduling’ of cannabis and for the DEA to prioritize public safety rather than criminalization.

Whether the DEA ultimately adopts the FDA’s recommendation remains to be seen. However, the agency’s comprehensive analysis, encompassing scientific research and direct user voices, demonstrates the growing momentum toward a potential shift in the federal government’s approach to cannabis.

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