FDA just approved the first prescription drug derived from marijuana: 4 outstanding questions
On Monday, the FDA approved GW Pharmaceuticals' Epidiolex, a medication that treats two rare forms of epilepsy. Made of cannabidiol (CBD), a chemical found in the cannabis plant that does not have psychoactive effects, it is the first marijuana-derived drug to receive a green light from the agency.
The approval answers one question but raises others. Here are four to watch:
How will the DEA handle CBD?
Epidiolex is derived from CBD. By approving the drug, the FDA has declared that CBD has a medical use. This runs in direct opposition to the Drug Enforcement Administration's stance, which classifies CBD, along with other marijuana components including THC, as a Schedule 1 drug, or a substance with “high abuse potential, no medical use, and severe safety concerns.”
So what happens now? The FDA “provides recommendations” to the DEA on scheduled substances, so it's likely that CBD will be reclassified as a Schedule 2 substance, opening the door for GW to market and sell Epidiolex.
GW seems confident in this interpretation. CEO Justin Gover released a statement saying he expects the rescheduling to occur within 90 days.
Does this mean the agency will reschedule marijuana?
Some have speculated that an approval for Epidiolex would open the doors for the DEA to reclassify marijuana, allowing for controlled clinical trials of CBD, THC, the main psychoactive component, and the drug as a whole. What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance.
Here's how FDA Commissioner Scott Gottlieb put it: “It's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD.”
So yeah, a blanket reclassification of marijuana looks unlikely, at least in the near future.
Will we see a flood of CBD products?
We already have, at least in the consumer space. There are already about 300 brands offering CBD products, according to AdAge. For those in the wellness space, the FDA's high-profile approval could provide a marketing boost.
That said, companies should be careful. Perhaps in anticipation of an onslaught of unfounded medical claims, Gottlieb warned that his agency will “continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims.”
How much will Epidiolex cost?
Epidiolex has been approved to treat two very rare forms of epilepsy. For GW to generate a meaningful profit on the drug, it would have to be expensive--but not too expensive, according to STAT.
In other words, GW needs to make the price high enough that it can make money on a small patient population without setting the price too high and drawing the ire of payers.