The first FDA-approved, cannabinoid-based pharmaceutical drug is now for sale in the U.S. After clearing all regulatory requirements, GW Pharmaceuticals’ CBD-based drug Epidiolex is now available in all 50 states. Although the U.S. government is now allowing this drug to be sold, the federal government still classifies actual cannabis as a Schedule I illegal substance.
Epidiolex is a seizure medication derived from cannabinoids that are naturally occurring in the cannabis plant. In particular, the drug is designed for patients 2-years-old and up. It is meant to treat two specific types of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.
Now that Epidiolex has received all necessary approvals, it is essentially treated as any other pharmaceutical drug. That means that patients with a prescription will be able to buy it. And GW Pharmaceuticals expects the drug to be covered by most insurance plans.
Notably, the drug will now be available to all patients regardless if they live in a medical marijuana state.
This is not the first time Epidiolex has made headlines. In fact, the drug’s move through the regulatory process has attracted a decent amount of attention.
For starters, an advisory committee recommended Epidiolex for approval back in April. That approval came relatively quickly when the FDA approved it in June.
Then, Epidiolex cleared the last remaining roadblocks in September. That month, the U.S. Department of Justice and the DEA both gave the drug the approvals needed to move it into the market.
In particular, the law enforcement agencies classified Epidiolex a Schedule V drug. Under that classification, the product is allowable as a prescription drug.
Interestingly, while Epidiolex was given Schedule V status, actual marijuana–from which Epidiolex is derived—remains a Schedule I drug. That category is reserved for “drugs with no currently accepted medical use and a high potential for abuse.”
Raising Questions in Medical Marijuana Community
For many in the medical marijuana community, Epidiolex’s relatively quick move into the market is not necessarily a thing to be celebrated. For starters, there are a lot of questions about why this pharmaceutical drug is approved as legal while actual cannabis—including THC and CBD—remains illegal.
Similarly, many have concerns over the price of the new drug. According to CNN, Epidiolex will cost $32,500 a year. And while GW Pharmaceuticals insists that price is in keeping with other anti-seizure medications, many are concerned by the high price point especially compared to regular medical marijuana.
In particular, Epidiolex has become a moment to question why marijuana—which can be grown and produced for much cheaper than an expensive pharmaceutical drug—is still illegal.
For some, the government’s willingness to approve a much more expensive pharmaceutical drug has the appearance of corporate favoritism.
And this is not the first time that there has been tension between pharmaceutical companies and the marijuana legalization movement.
Last year, Insys Therapeutics received DEA approval to develop its own synthetic marijuana drug. The part that really rubbed the medical marijuana community the wrong way is that Insys was also one of the largest single donors to a campaign to keep marijuana illegal in Arizona.
In both of these cases, there are suspicions about the seeming collusion between government agencies and “big pharma.” Simply put: the government seems much more willing to let large pharmaceutical companies like these push their marijuana-based drugs onto the market instead of simply allowing patients to access medical marijuana directly.