In what many are viewing as progressive – albeit hypocritical – the U.S. Food and Drug Administration approved Epidiolex, a CBD-based medication produced by GW Pharmaceuticals and used to treat certain epilepsy disorders.
What’s problematic about this is the fact that all other CBD based products are still categorized as Schedule 1 drugs. The rescheduling order, which was released last week and published in the Federal Register, simply states that “this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V.” Note, only FDA approved drugs.
So instead of clearing all products containing certain quality and levels of CBD, each individual product will be subject to the FDA’s approval process, which is expensive, time-consuming, and often biased. The FDA advisory committee frequently shows favoritism for the companies that sponsor them.
Also concerning is that, with only one CBD medication currently approved, GW Pharmaceuticals has a monopoly over the industry. For reference, Epidiolex is expected to cost $32,000 per year and may or may not be covered by insurance. Although this is relatively standard pricing for epilepsy medication, it’s tens of thousands of dollars more than even the most high-end CBD products available for purchase online.
It’s a tough blow for patients who are looking for alternative treatment options but don’t want to be forced into the black market. Common side effects associated with regular anti-seizure medication include dizziness, nausea, headache, vomiting, fatigue, vertigo, ataxia, blurred vision, and ironically tremors. CBD has no side effects… Naturally, people are interested in something that’s natural and not so debilitating.
It’s fantastic that the FDA is beginning to approve CBD-derived medications, but they shouldn’t be regulated to the point that patients can no longer access these products easily and affordably. Cannabis has been used for thousands of years and has proven itself to be safer and more effective than many standard treatment options. Regardless, we’ll keep looking at this as a step in the right direction and hope for the best when it comes to CBD industry regulation.
According to GW Pharmaceuticals, they anticipate Epidiolex to be available in about six weeks.
(image credit: GW Pharmaceuticals plc)