On Monday, April 6, GW Pharmaceuticals announced that the company received notice from the U.S. Drug Enforcement Administration (“DEA”) stating that GW's drug Epidiolex was no longer subject to the requirements of the Controlled Substances Act (“CSA”).
In the company release revealing the agency decision, GW CEO Justin Gover summarized, “This notification from DEA fully establishes that Epidiolex, the only CBD medicine approved by the Food and Drug Administration, is no longer a controlled substance under the federal Controlled Substances Act.”
Initially launched by the pharmaceutical company in late-fall 2018, Epidiolex is the first and sole cannabis-derived medication approved by the Food and Drug Administration (“FDA”), utilizing hemp-derived active ingredient cannabidiol (“CBD”) to treat rare epileptic seizure disorders.
In the months and years after Epidiolex’s release, CBD has become its own unique regulatory challenge after exploding onto the consumer market in recent years. The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”) removed extracts of industrial hemp from Schedule I of the CSA, but FDA officials have failed to develop guidelines for CBD consumer products.
Currently, all non-Epidiolex CBD products are considered to be illegal by the FDA. Despite significant attempts to change CBD’s status by the industry, FDA has taken the position that CBD’s safety profile has not been established and that consumer products containing the substance are “adulterated” and “misbranded drugs.”
The Administration’s stance is outstandingly contradictory considering that in a 27-page letter to the Acting Administrator of the DEA in May of 2018, FDA officials strongly argued the lack of risk associated with CBD stating that:
"Upon consideration of the eight factors determinative of control of a substance under section 201 (c) of the CSA, FDA concludes that CBD and its salts … could be removed from under the CSA… We reach this conclusion because we find that CBD does not meet the criteria for placement in and of Schedules II, III, IV, or V under the CSA.”
With the DEA decision effective immediately, the company notes that it will now undergo the process of updating operations accordingly throughout Epidiolex’s distribution network on a state by state basis.
Upon receiving the DEA notification, GW has filed to have the FDA’s previous Schedule V designation of Epidiolex removed. The epilepsy medicine will require a doctor’s recommendation; however, prescription expiration and acceptance are expected to broaden for patients.
The information in this blog post (the "Blog" or "Post") is provided as news and/or commentary for general informational purposes only. The information herein does not, and shall never, constitute legal advice and therefore cannot be relied upon as a legal opinion. Nothing in this Blog constitutes attorney communication and is not privileged information. Nothing in the Post or on this website creates any kind of attorney-client relationship or privilege of any kind.
Originally published April 8, 2020, at https://therodmanlawgroup.com.
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