• Randy Shaffer

FDA-approved Marijuana Drug May Pave the Way for DEA Rescheduling


In June, the FDA approved the first-ever marijuana-derived drug for use with two rare forms of childhood epilepsy. The medicine, Epidiolex, uses a cannabis compound called Cannabidiol, otherwise known as CBD. Unlike current CBD products for sale on the market, which derive their CBD from hemp, Epidiolex sources its CBD from cannabis, though THC is still filtered from the drug, meaning the drug will not create a "high" in its user. The downside, however, is that this drug won't be cheap.


Business Insider reports that GW Pharmaceuticals, the British-based company who makes the drug, said Epidiolex would cost roughly $32,500 per year for patients to obtain. This is no small amount, even for the super rich. But GW spokesperson, Julian Gangolli, suggested that the price point is set to remain competitive with other epilepsy drugs currently on the market.


That said, it's not very likely a CBD drug would cost $32,500 to manufacture considering holistic shops are already selling hemp-derived CBD drops and tinctures for around $100. That's roughly a 31,900% markup, or 320x the asking price of holistic CBD. It remains to be seen whether quality matches the price tag.


So how can a cannabis-derived drug be approved by the FDA when the Drug Enforcement Agency still lists cannabis as a Schedule I narcotic? To even get on the Controlled Substances Act Schedule I list, the drug must meet the following criteria:

  1. The drug or other substance has a high potential for abuse.

  2. The drug or other substance has no currently accepted medical use in treatment in the United States.

  3. There is a lack of accepted safety for use of the drug or other substance under medical supervision

Of course, there's been a lot of research to suggest for some time that marijuana should NOT be considered a Schedule I drug. Killer opiod drugs like Fentanyl, for example, are only listed as Schedule II drugs, which would allow them to be used for medicinal purposes.


At the very least, marijuana should be classified as a Schedule II drug. This would allow for better Federal regulation of the drug in states where it has been approved for medical purposes, potentially freeing up insurance companies to finally cover medical marijuana, allowing companies that sell marijuana to access banks and file taxes easier, and workplaces to loosen their restrictions making it illegal for an employer to fire someone who's prescribed marijuana by a doctor ... just to name a few.


But Epidiolex may have started a wave that won't wash away so easily, and though the drug is expensive, it could finally lead to marijuana rescheduling, a game changer for the medical marijuana industry. "We expect to make Epidiolex available to U.S. patients this fall, following rescheduling, which is expected to occur within 90 days of FDA approval," said GW Pharmarceuticals' CEO Justin Gover in a call to investors in June. "We have been building commercial inventory in recent months and are in a position to ship product into the U.S. supply chain, once rescheduling is complete."


DEA public affairs officer Barbara Carreno echoed this sentiment when speaking with Business Insider in June, "We don't have a choice on that. [Marijuana] absolutely has to become Schedule 2, 3, 4, or 5."


So will marijuana finally be removed from Schedule I, and placed further down the channel, perhaps to Schedule 2 or 3 (or lower)? That remains to be seen, but the 90-day deadline for the DEA decision will hit in September. Stay tuned to this space for future updates! In the meantime, find out how our doctors can help you get your medical marijuana card in Ohio.