FDA Approves CBD treatment for Epilepsy
The newly approved CBD drug (Epidiolex) is used in patients two years of age and older who suffer from seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.
In April (2018), a panel of outside advisers to the FDA had unanimously voted that the Epidiolex’s benefits significantly outweigh its risks and while FDA approval had seemed likely following that advice, the treatment has finally been approved following extensive discussions and clinical trials.
FDA Commissioner Dr. Scott Gottlieb said "This is an important medical advance. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery."
A selection of our products
This is the first FDA-approved medication derived from a cannabis plant and could prove to be a turning point in the fight to have CBD fully legitimized and legalized across the US.
Significantly, this is the first instance in which CBD will stand alongside other treatments in the American medical industry, thus helping to remove any remaining stigmas about its use as a legitimate medical treatment.
While there are many who remain skeptical about the benefits of CBD, the acceptance of a CBD treatment into local pharmacies may just start to persuade those with any lingering doubts about CBD’s validity as an accepted medical treatment.
As a consequence of the FDA ruling, it has been suggested that the DEA must now reschedule cannabis and CBD from its current scheduling as a class 1 drug.
Under the 1970’s Controlled Substances Act, the cannabis plant and its products have been labeled Schedule I substances, making them illegal in all circumstances. It was determined that cannabis has no accepted medical use; cannot be used safely, even under medical supervision; and has high abuse potential.
However, with this particular CBD treatment now given approval, there now exists a direct conflict in the legal basis for the prohibition of cannabis in the United States.
As a result, It has been suggested that a reschedule of the CBD compound is now necessary to uphold the Controlled Substance Act.
With cannabis still listed as a Schedule I drug, suggesting that it has “no known medicinal value,” it is suggested that the FDA cannot allow this newly approved CBD treatment to go to market without making a change to its classification.
Barbara Carreno, a public affairs representative for the DEA, recently told Business Insider that the agency has 90 days to put CBD into a lower classification.
"We don't have a choice on that,” she said, “It absolutely has to become Schedule 2 or 3."
Speculation Adds to the Confusion
Others have been quick to downplay the suggestion that CBD will be given any new classification in the coming months.
Shawn Hauser, a senior associate with Vicente Sederberg LLC, and director of the Denver-based law firm’s Hemp and Cannabinoid Group explained that while Epidiolex will be given a new classification, CBD will not.
“There is a misunderstanding that cannabis or CBD will be immediately rescheduled, but that is not the case; it will be Epidiolex itself. Still, the potential for cannabis or CBD is groundbreaking,”
“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. Cannabis is still a Schedule I substance; CBD is not scheduled itself, but as a substance derived from cannabis.”
Certainly, there seems to be a distinct lack of clarity on the future classification of CBD but it would appear that the approval of this CBD treatment could open the door for a whole line of potential CBD treatments to gain future FDA approval.
Reclassification Now a Must
While the lack of clarity on cannabis and CBD classification continues to cloud both our medical and justice system, the decision to approve a cannabis-derived treatment must surely force the hand of the federal government.
Since the 1970’s, federal regulators have repeatedly denied rescheduling petitions for cannabis but the decision to approve a treatment derived from cannabis has opened the door to further conversations on the scheduling of both cannabis and CBD.
With their current class 1 status continuing to prevent future research, surely now is the time for the federal government to act swiftly and sensibly to resolve a situation that continues to deprive millions of Americans the access to treatments that could change their lives.
With the FDA ruling that CBD has a place in our society as a medical treatment, it is now essential that our federal government reclassifies CBD in the DEA’s list of controlled substances.
Under the current system, cannabis used for research in the US is supplied by just one domestic source: a farm at the University of Mississippi. Just one!
This monopoly was expected to change in 2016 when the DEA indicated that it was willing to expand the number of domestic producers. However, in the past 2 years and despite dozens of applications from multiple institutions, the Justice Department has approved not a single one of those requests.
With the approval of this CBD treatment, however, it is clear that the FDA has sent out a strong message to the federal government, and more specifically, to the DEA, that medicines derived from cannabis are legitimate and should be regulated for their safe consumption within the US.
At present, hemp- derived CBD is completely legal in all 50 states in the US, while CBD that is derived from other strains of cannabis are the ones that still remain unclear of the legality. Some states do have provisions that allow for its medical use, but surely we need more consistency in the law at a both state and federal level to ensure a far greater degree of clarity.
With CBD now entering the medical industry, we hope that cannabis will no longer be subjected to this demonization and will be accepted by the mainstream.
Whether such messages are being heard in the current administration remains to be seen, but there can be no doubt that a sea of change is currently engulfing the US today, and will only continue to grow in the coming months and years with more and more people waking up to the many potential benefits of CBD.
In the future there now seems hope that cannabis and CBD could potentially be reclassified federally, to be fully legitimized and legalized. Thanks to the decision of the FDA, such a transformation may well be on the horizon.