This is Washington, and we do like to speak in initials. A plain English translation of the title of this piece would read “FDA ‘places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.’” DEA Final Order, Docket No. DEA-486 Schedule V drugs include cough medicine with codeine and many pain relievers that still require a prescription. So, really what this order does is allow doctors in the US legally to prescribe the recently approved epilepsy drug, Epidiolex, and allows pharmacies, rather than marijuana dispensaries, legally to sell the drug.
Why this is a big deal–this is the first time in decades that the federal government has moved any form of cannabis off of Schedule I under the Controlled Substances Act, and this could jump start more medical research in CBD which could eventually lead to a complete de-scheduling of CBD.
Why this is not a big deal–many thought that following the approval of Epidiolex, the FDA would completely de-schedule cannabis, but it did not do that. What it did, instead, was to find a narrow path to allow the legal sale of Epidiolex in the United States. The FDA approval is limited to FDA approved drugs that contain a very limited amount of CBD. At the moment, Epdiolex is the only drug that falls within that definition. Since biotech start-ups and small pharma companies usually do not have the resources to secure FDA approval of a new drug, some see this order as benefitting only big pharma. While this may be true in the short term, this order may make it easier for biotech start-ups and small pharma engaged in CBD research to attract the capital needed to get through the FDA approval process.
There still remain at least three big open questions. What about state law? Cannabis in any form is still illegal in 19 states. Since each state’s law is different, a state by state analysis will be necessary to determine if the FDA approval is enough to make the sale of Epidiolex legal in those states. A second open question has to do with insurance. According to Hemp Industry Daily, the manufacturer of Epidiolex, GW Pharmaceuticals, has announced that it will charge $32,500 for Epidiolex treatments. Will insurance companies cover the cost of these treatments? Finally, there is the question of off label use. Will doctors prescribe an FDA approved drug containing CBD for an indication other than its intended use? If so, this could increase the attractiveness for investors seeking a stake in cannabis.
As with all things cannabis, we have to wait and see how this plays out both at the federal and state levels.