FDA Approves First Cannabis-Derived Pharmaceutical
Last week the U.S. Food & Drug Administration (FDA) approved the first cannabis-derived pharmaceutical known as Epidiolex. Created by London-based biopharmaceutical company, GW Pharmaceuticals, and in conjunction with its U.S.-based subsidiary, Greenwich Biosciences, Epidiolex will be sold and used exclusively for the treatment of two rare and severe forms of epilepsy: Lennox-Gastaut and Dravet syndromes.
The fact that the FDA has approved Epidiolex is further evidence of the benefits of cannabis-derived products, supplements, and therapeutics. But where does this approval leave the classification of other cannabidiols, like PMB’s Nano-Enhanced Hemp Oil? It’s likely that with Epidiolex’s approval by the FDA, the DEA will have to reclassify the scheduling of cannabidiol under the Controlled Substances Act (CSA), potentially within the next 90 days. Rumor has it cannabidiol could be changed to a Schedule IV or Schedule V on the CSA, the same scheduling classification as anxiety drugs like Xanax and Klonopin, and other seizure medications.
According to cannabusiness law firm Hoban Law Group, the FDA’s approval of Epidiolex has no immediate impact on the laws that currently surround industrial hemp or the recent positive rulings by the Ninth Circuit Court in the Hemp Industries Association vs. DEA case—that state the Farm Bill “preempts” the Controlled Substances Act and where the DEA conceded is does not “seek to control cannabinoids.”
Representing attorneys at Hoban Law Group expect the DEA to undertake a process about how to evaluate Epidiolex and schedule the new drug under the CSA. HLG also points out the FDA’s position concerning the CBD market remains unchanged, as the Epidiolex approval was based solely on an Investigational New Drug (IND) application that was submitted years ago.
Hoban Law Group has informed PMB they will be evaluating options and will stand ready to overturn the FDA’s position toward cannabidiol to ensure hemp-derived supplements and similar products are protected under the FDA’s new regulatory framework. HLG is also committed to making sure the DEA stands by its statements in a directive to federal agencies released in May that states cannabinoids are not controlled substances unless they fall under the definition of marijuana, and “the mere presence of cannabinoids” in any product or derivative does not render it a controlled substance.
We will be sure to keep you updated on further announcements and updates by the FDA, DEA, and Hoban Law Group.