Today was a historic day with the U.S. Food and Drug Administration (FDA) announcing that it has approved Epidiolex.
The medication is an oral solution derived from cannabidiol (CBD) that treats seizures associated with two severe forms of epilepsy (Lennox-Gastaut syndrome and Dravet syndrome).
Epidiolex is the first FDA-approved drug that contains a purified substance derived from cannabis.
It is also the first FDA-approved drug that treats patients diagnosed with Dravet syndrome.
Approval of the medicine is a really big deal in many ways but a major hurdle has to be overcome before it can hit pharmacies.
DEA rescheduling is required
A press release from GW Pharmaceuticals and its subsidiary Greenwich Biosciences announced that before its products can be purchased by patients the DEA has to reschedule CBD.
The press release claimed that rescheduling of CBD is expected to occur within the next 90 days.
Until the federal government issues an announcement corroborating the claim made by GW Pharmaceuticals the 90-day timeline needs to be taken with a grain of salt.
It’s quite possible that the rescheduling occurs within 90 days, but it’s also quite possible that rescheduling comes well after the deadline has passed.
Cannabis advocates have been bemoaning cannabis’ Schedule I status for decades but moving cannabis away from the Schedule I category has proven to be extremely difficult.
Today’s approval could be the start of the end of cannabis’ current federal status, at least for CBD, Ultimately only time will tell.
How much will Epidiolex cost?
Epidiolex’s success will largely depend on how much it costs. If it is too expensive, many patients will avoid it due to not being able to afford it or choosing to continue to use less expensive medicines.
Cannabis-derived medications are particularly tricky because raw cannabis is readily available in most parts of the country either legally or illegally.
It wouldn’t take much for patients to continue to continue to acquire cannabis the way that they have been doing already.
According to a report from The New York Times Epidiolex is expected to sell for between $2,500-5,000.
If insurance companies cover the cost of Epidiolex the final cost to the patient could be reasonable, but otherwise, patients will likely pass on that price and opt for other forms of medicine.
Descheduling is better than rescheduling
Today’s announcement was celebrated by many cannabis advocates, while other members of the cannabis community expressed reservations.
Some members of the cannabis community fear that if CBD is rescheduled to Schedule II that descheduling may never occur.
The fear is well founded because it’s quite possible that rescheduling CBD, or any part of the cannabis plant, could give pharmaceutical companies the monopoly on legal cannabis.
They point out that descheduling cannabis is better than rescheduling because cannabis policy should be left completely to individual states to decide.
A bill currently in Congress, the Strengthening the Tenth Amendment Through Entrusting States (STATES) Act of 2018, would do exactly that.