On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex, an orally administered drug derived from the marijuana plant, Cannabis sativa. The drug is approved for use for patients two years and older, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, both of which are rare and severe forms of epilepsy. It is the first drug that FDA has approved for Dravet patients.
The drug contains purified cannabidiol (CBD). In its press release, FDA points out that although CBD is derived from marijuana, “it does not cause intoxication or euphoria (the ‘high’) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.”
FDA Commissioner Scott Gottlieb, M.D. provided words of encouragement for the industry but, at the same time, expressed caution. He stressed the importance of the FDA approval process, including evaluation of data from adequate and well-controlled clinical studies. He also indicated that FDA was committed to continuing to support research on the potential medical uses of marijuana-derived products and work with product developers. However, he emphasized that FDA is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” This is consistent with FDA’s past targeting of companies marketing products as cancer cures or making other claims about the ability to treat serious and potentially fatal diseases.
With this recent drug approval by FDA, the DEA will be next in line to make a determination with regard to CBD, which is currently listed as a Schedule I substance under the Controlled Substances Act (CSA). By definition, a Schedule I drug is one with no currently accepted medical use and a high potential for abuse. Although FDA provides DEA with recommendations and prepares and transmits medical and scientific analyses of substances subject to scheduling (like CBD), the DEA makes the scheduling determinations.
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