This is just a glimpse. Want to receive every issue of Cannabis Wire Daily, our newsletter that is sent to subscribers each weekday morning, and unlimited access to cannabiswire.com?
U.S. FDA touts cannabis scheduling work in report on priorities.
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research released a report this month titled “Drug Safety Priorities Fiscal Year 2023.”
Throughout the report, the Center repeatedly references its work that led to the recommendation by the U.S. Department of Health and Human Services that cannabis be moved from Schedule I to Schedule III.
In the report introduction, Patrizia Cavazzoni, the director of CDER, wrote:
“In response to the Administration’s directive to explore whether marijuana should remain listed as Schedule I under the Controlled Substances Act, we conducted an expansive review of numerous data sources to inform a scientific and medical assessment called an Eight Factor analysis (8FA). This review informed FDA’s recommendation to the Drug Enforcement Administration (DEA) to down-schedule marijuana to Schedule III. We also completed an assessment of the capabilities and usefulness of a variety of epidemiologic, pharmacovigilance, and drug utilization data sources for monitoring the safety of unapproved cannabis-derived products.”
Later in the report, in a section on “pharmacovigilance,” CDER wrote that as part of its “cross-center evaluation of marijuana, the CDER Office of Surveillance and Epidemiology (OSE) completed a review of epidemiologic and pharmacovigilance data sources to inform the 8FA provided to DEA. We also coauthored published articles in peer-reviewed scientific journals about safety issues with various drugs, including those involving products that include or are related to cannabidiol.”
And again, in a section titled “Proactive Pharmacovigilance Through Social Media Monitoring and Analysis,” CDER wrote that its researchers “completed a detailed qualitative analysis of online and social media conversations occurring about marijuana as one of several research studies CDER conducted to address the administration’s directive to explore whether marijuana should remain listed as Schedule I under the Controlled Substances Act. This six-month study involved manually analyzing hundreds of posts on publicly available online/social media platforms to provide 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.”
Clinical trial will explore alcohol and cannabis co-use.
Colorado State University researchers are conducting a clinical trial that will “explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics.”
Eligible participants will be randomized into groups (alcohol, cannabis, or both) for study sessions in a mobile lab.
The study will be completed in 2026.
In Ukraine, President Volodymyr Zelensky signs medical cannabis bill into law.
President Volodymyr Zelensky signed a limited medical cannabis bill into law this week, and it will go into effect in six months. The bill gained traction amid the war with Russia, as lawmakers argued that those with PTSD stand to benefit.
