The story of GW Pharmaceuticals in the United States is one of firsts.
In 2018, the British company became the first to obtain approval from the US Food and Drug Administration for a product derived directly from cannabis plants. That same product, Epidiolex, a CBD formula for patients with rare forms of epilepsy, just achieved another first for a cannabis-derived pharmaceutical: total descheduling by the US Drug Enforcement Administration, meaning it is off the list of controlled substances and no longer under the agency’s purview.
“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said GW’s CEO, Justin Gover, in the announcement. “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”
Until recently, it was generally understood that cannabis and its cannabinoids, compounds like THC and CBD that are produced by the plant, were in Schedule I, the most restrictive category, reserved for substances considered to have no medical value and a high abuse potential. Pharmaceutical products containing cannabinoids were in less restrictive categories. For example, Marinol—a drug to prevent nausea or to increase appetite, which contains synthetic THC and was approved by the FDA decades ago—is in Schedule III. Epidiolex, when approved, was originally placed in Schedule V.
The 2018 Farm Bill somewhat upended that. By legalizing hemp, which is defined in the Bill as cannabis plants with less than .3% THC, the Bill essentially descheduled low-THC cannabis plants and every cannabinoid except THC. This doesn’t mean it’s a free-for-all for cannabinoids like CBD, which is why the FDA has spent months crafting regulations on just which CBD-containing products, exactly, are allowed. Cosmetics? Generally. Food and drinks? No. Or, not yet. (Catch up on Cannabis Wire’s coverage of the FDA rulemaking around CBD products.)
But when it comes to CBD-based pharmaceuticals, what’s certain is that they will no longer be scheduled.
“Since the Farm Bill pulled CBD out of the scheduling process, well, they had to move to deschedule that,” Melvin Patterson, staff coordinator at the DEA, told Cannabis Wire. “CBD products that have more than .3% THC, then that’s considered a controlled substance, if you will. Epidiolex, that’s something that has very, very little to no THC, and you can’t get high from that at all.”
GW Pharmaceuticals, via its US subsidiary Greenwich Biosciences, has been lobbying in all fifty US states, as Cannabis Wire reported. Further, when it came to federal lobbying last year, Greenwich outspent every other cannabis company or organization, according to a Cannabis Wire analysis of disclosure reports.
GW’s dominance in cannabis-based medicines is international. In late 2019, NHS England announced it would provide reimbursement for Epidyolex, as it’s known in the UK, following a recommendation to do so from the UK’s National Institute for Health and Care Excellence.
So significant is GW’s presence globally that Epidiolex is factoring into a forthcoming global vote on cannabis as medicine. As Cannabis Wire reported, a vote on whether to reschedule cannabis was set to take place in March at the United Nations Commission on Narcotic Drugs 63rd Session. To reschedule the drug would recognize its utility as a medicine. But member states agreed to delay that vote until December 2020.
One of the World Health Organization recommendations up for a vote at the United Nations session involved descheduling CBD products containing less than .2% THC. In response to a question from the US regarding flexibility in that percentage, and to a back and forth about Epidiolex, the WHO explicitly said, “The value of 0.2% for THC was specified as WHO had requests from Member States to indicate what maximum percentage was considered appropriate and to ensure that the currently registered CBD medication was exempted from control.” (Italics added.)
For companies like Biopharmaceutical Research Company, which, as Cannabis Wire reported, is seeking federal approval to cultivate and supply cannabis for research and to conduct R&D activity, GW’s announcement is good news.
“This descheduling of Epidiolex further confirms that the US DEA is adhering to the legal mandate that it doesn’t have the authority to regulate cannabidiol products produced in compliance with the 2018 Farm Bill as opposed to the Controlled Substances Act,” the company’s founder, George Hodkin, told Cannabis Wire. “It also underscores that working alongside regulators and working within the legal frameworks, despite the challenges they pose, is the way to create long-term value for patients as opposed to flouting federal law. BRC applauds the pioneers at GW for navigating the complex regulatory pathways in order to maximize the number of patients they can serve.”