CDB Cannabis - FDA Health Policy Law
The US Food and Drug Administration approved the first cannabis-derived drug this week, but it can’t be sold until the Drug Enforcement Administration changes how it classifies the specific compound used. So what’s next?
Epidiolex treats serious forms of childhood epilepsy and contains the compound cannabidiol (CBD). Though CBD comes from cannabis, it won’t cause anyone to get high; it’s the compound THC that is psychoactive. But because it comes from cannabis and cannabis overall is classified as a Schedule I drug with “no currently accepted medical use and a high potential for abuse,” pharmaceutical companies aren’t allowed to sell it unless the DEA reclassifies CBD.
It is likely that the DEA will reclassify CBD in the next 90 days, says Stephanie Yip, an analyst at Informa Pharma Intelligence. (Epidiolex manufacturer GW Pharmaceuticals has said the same.) Most likely, according to Yip, it will be changed to Schedule IV or Schedule V, which are schedules that include other anti-seizure medications and anxiety drugs like Xanax and Klonopin.
This doesn’t mean that cannabis as a drug will be removed from Schedule I though. Yip points out that the FDA already approved two nausea drugs — dronabinol and nabilone — that use synthetic versions of THC. The DEA scheduled these drugs as Schedule III and II, respectively, but still didn’t reschedule cannabis. Plus, FDA Commissioner Scott Gottlieb said in a press release that Epidiolex approval “is not an approval of marijuana or all of its components.”
If these synthetic THC drugs can be approved and rescheduled, and CBD can be rescheduled, what’s keeping the DEA from rescheduling cannabis itself? “Cannabis contains so many different compounds and strains,” explains Yip. “The FDA has just approved this singular product through stringent testing and doses and specific concentrations. It’s gone through rigorous clinical reviews and FDA review, but the FDA is likely to still crack down on claims made with other products.”
To be clear, there are already plenty of CBD products easily available, from supplements to oils to various beauty products like soap. But it’s one thing to sell them as supplements, and another to sell them as drugs. “You can get vitamin C from oranges at the grocery store, or you can get a clinical preparation of vitamin C to treat a disease, and those two items are treated very differently,” says Chris Stubbs, chief science officer of hemp farming and genetics company GenCanna. Clinical CBD is much more tightly regulated.
Still, the reclassification will likely make medical cannabis more legitimate. Rite Aid, for example, has already said it will fill prescriptions for Epidiolex, which is likely to be available at pharmacies in the fall. (It won’t be available in dispensaries because FDA-approved drugs can only be sold at places with a pharmaceutical license.) And GW Pharmaceuticals is already investigating other CBD-derived drugs to treat different forms of epilepsy, as well as forms of brain cancer and schizophrenia. “This approval is definitely going to encourage other companies to investigate [other cannabis] compounds for different diseases,” she says, “from pain to Alzheimer’s to multiple sclerosis to Tourettes’. Basically a whole spectrum of diseases.”
Correction July 1, 2018 10:40 a.m.: An earlier version of this article misspelled Stephanie Yip’s last name.