Last week, the U.K. based pharmaceutial company, GW Pharmceuticals, hit a home run in terms of potential drug sales. Epidiolex, their plant-based CBD solution, was descheduled by the DEA. This removed the label of Epidiolex as a “controlled substance” and will make it much easier for prescribers and insurers to deliver Epidiolex to patients, even with a $32,500 annual price tag. Controlled medications have much more stringent rules in regards to distribution.
Plant-based CBD has gone through some major transformations in the last 22 months. Originally, CBD, the non-psychoative molecule in cannabis that has potent anti-inflammatory and other beneficial effects for the human body yet to be discovered, was scheduled as an illegal Schedule 1 substance by the federal government back in 1970.
After 80 years, this changed when Epidiolex was approved in June of 2018 for rare forms of epilepsy.
It is important to note the timing of all these events.
Epidiolex was approved in June while CBD was still scheduled as an illegal Schedule 1 drug. In the fall, CBD was then rescheduled to a legal, Schedule 5 drug. While this is going on, hemp was legalized in the United States Farm bill which became law in December of 2018.
Did you catch how that all played out?
1. CBD illegal
2. Big Pharma gets approval of CBD
3. CBD rescheduled to legal Schedule 5
4. Farm bill legalizes CBD in pharmaceutical medications only
5. CBD completely descheduled in April 2020
This does not mean CBD is now a legal substance from which everyone can benefit.
CBD is legal only when contained in product derived from hemp that has less than 0.3% THC. I find this confusing. Why is CBD being singled out? CBD is the same molecule whether derived from a plant with 30% THC or no THC. Why is the molecule itself still restricted?
Being that CBD is now considered a pharmaceutical product, it is now against the law to have CBD in drinks or food products. All of this is very confusing and if someone with a legal degree can explain this to me, I would greatly appreciate it.
This is a big move by Big Pharma. In the end, CBD is now more accessible to patients through the pharmaceutical industry but not as widely available through over the counter routes which could help to drive the price down. Like I said…..a corner piece of this massive cannabis-industry puzzle.