On Sept. 27, the Drug Enforcement Administration rescheduled Epidiolex, a cannabis-derived medication to treat seizures, so that it now is listed under Schedule V of the 1970 Controlled Substances Act. This rescheduling means that the DEA is acknowledging the drug has a low potential for abuse and has an accepted medical use for treatment.
But the CBD cannabinoid itself that is the active ingredient in Epidiolex has not been rescheduled and remains in Schedule I — which means that the DEA considers cannabis-derived CBD to have a high potential for abuse and no current accepted medical use.
The annoucement came in Thursday’s Federal Register and was affirmed by a press release from Epidiolex’s manufacturer, GW Pharmaceuticals. However, the Federal Register will remain in an unpublished form until Friday, Sept. 28, which means the specific language of the DEA has not been finalized but the message that Epidiolex and not CBD will be rescheduled remains clear.
This is the first time that the DEA has rescheduled a medication derived from cannabis itself. Previously, in 1986, the DEA rescheduled Marinol, which is derived from synthetic THC.
The rescheduling process began with the Food & Drug Administration’s June 25 approval of Epidiolex, despite the fact that the DEA considers its active component, cannabis-derived CBD, to be a Schedule I substance with no medical applications. With the two agencies now in direct policy conflict with each other, the DEA was obliged to reconsider the status of CBD — or at least Epidiolex. The product’s manufacturer announced that it expected the DEA to issue a decision within 90 days.
GW Pharmaceuticals, the British firm who manufactures Epidiolex, has made the United Kingdom the world’s biggest producer of legal cannabis. It is also one of the first businesses dealing in legal cannabis to be listed on NASDAQ, and its stocks started rising before the announcement of the Epidiolex ruling.
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with Lennox-Gastaut syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said Justin Gover, GW Pharmaceutical’s chief executive officer.
Gover said that GW Pharmaceuticals is now working to make Epidiolex available “within the next six weeks,” citing the public excitement around the new seizure medication. An annual prescription for Epidiolex is anticipated to cost patients $32,500, which GW Pharmaceuticals says is in line with other epilepsy medications.
Following the FDA’s approval of Epidiolex, the FDA’s commissioner Scott Gottlieb cautioned the DEA in his press release on the Epidiolex decision.
“It’s… important to note that this is not an approval of marijuana or all of its components,” Gottlieb said. “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. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”
So, it appears that the FDA supports the DEA’s decision to issue a narrow rescheduling on Epidiolex but not CBD. However, this could point to a slow piecemeal approach that the federal government could take to approve cannabis-derived products one-by-one moving forward — assuring that corporate control and a profit-driven system are maintained and that large pharmaceutical companies can dominate the federal medical marijuana industry. This is obviously and dramatically at odds with the ethics of self-sufficiency and self-medication that were at the root of the medical marijuana movement a generation ago.
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