The U.S. Food and Drug Administration (FDA) last week made history: By giving approval for U.K.-based GW Pharmaceuticals PLC-ADR GWPH application to market Epidiolex (to medically treat severe forms of epilepsy), it marked the FDA's groundbreaking admission that cannabis has medical value.
That said, despite some companies trying to leap into the fray of a perceived new CBD market, nothing else has (yet) changed. Cannabis and raw CBD remain federally illegal. For now, Epidiolex itself remains illegal for sale, pending the DEA's scheduling decision (likely as Schedule IV), due by September 23.
"There is misunderstanding that cannabis or CBD will be immediatelyrescheduled, but that is not the case; itwill be Epidiolex itself. Yet the potential for marijuana or CBD is groundbreaking," explained attorney Shawn Hauser, senior associate with Vicente Sederberg LLC, and director of the Denver-based law firm's Hemp and Cannabinoid Group. "What is getting scheduled is the Epidiolex itself, pursuant to the new drug application, relating to its medical efficacy and low potential for abuse," she said. "That will inform the federal law for the future. Marijuana is still a Schedule I substance; CBD is not scheduled itself, but as a substance derived from marijuana."
The DEA has said that it has no plans to reschedule or deschedule cannabis per se, but that there is "discussion" about rescheduling CBD. Neither is likely to be changed with Epidiolex's approval since individual drugs often receive their own schedule. Nevertheless, for the federal government to acknowledge the medical applications is huge.
Research scientists, doctors, and hospital administrators are governed by federal — not state — law, which has made the study of cannabis a risky, time-consuming endeavor. That's now about to change, once the DEA schedules Epidiolex. Preliminary evidence suggests that CBD has use not just for epilepsy, but a whole host of neurological diseases, from Alzheimer's and Parkinson's, to multiple sclerosis, and some forms of brain cancers. Neuroscientists are anxious to examine the potential and parameters for cannabis' medical applications; they will finally be at liberty to do their work.
"It will have a positive impact on the industry as a whole while providing patients with treatment for a severe form of epilepsy," Hauser added. The approval also serves as a reminder that itis important for marijuana and hemp businessesnot to make unlawful drugclaims. Businesses should be aware that's illegal and creates significant risk."
As an FDA-approved pharmaceutical, Epidiolex can only be sold in licensed pharmacies, not dispensaries. Conversely, dispensaries are licensed by state agencies, and can only sell products authorized within a state program. Meanwhile, Epidiolex will likely be more expensive than CBD treatments within a state medical program, which typically cost $200 to $500 a month. But as an FDA-approved drug, Epidiolex can be covered by insurance, while state-authorized medical cannabis is not.
The dynamic begs the need for regulated standards. For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 products purchased from 31 different online CBD sellers. About 70 percent of them had different levels of CBD than labeled, with nearly 50 percent having more CBD than indicated, and 25 percent having less. And 18 (or 21 percent) of the samples tested positive for THC, though not listed on the label.
"Hopefully we will see an expansion of research and other legitimatepharmaceutical medicines," Hauser concluded. "There is a need for development of cannabis-based medicines, and forpatients to have access to cannabis as medicine. This could be a milestone that allows for more opportunities for research into cannabis; we as a country have been behind Israel and countries with fewer barriers on research into marijuana. I do not think that there will be any immediate avalanche effect on federal legislation, but I think it is generally positive for the industry to have a pharmaceutical lane for cannabis in addition to adult-use and nutraceutical lanes."
J.J. McCoy is Senior Managing Editor for New Frontier Data. A former staff writer for The Washington Post, he is a career journalist having covered emerging technologies among industries including aviation, satellites, transportation, law enforcement, the Smart Grid and professional sports. He has reported from the White House, the U.S. Senate, three continents and counting.
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