In late June 2018, the Food and Drug Administration (FDA) approved Epidiolex for sale in the U.S. It is the first prescription drug derived from the marijuana plant. The drug is designed to treat seizures for two rare forms of epilepsy: Dravet Syndrome and Lennox-Gastaut Syndrome. “Fast-track” designation was given to the drug during its approval process because it was the first FDA approval of a drug for the treatment of patients with Dravet Syndrome.1 “Orphan drug” designation (special status given to a drug that treats a rare condition or disease) was also given to the drug for use as a treatment for both Dravet Syndrome and Lennox-Gastaut Syndrome.
While synthetic THC-derived drugs such as Marinol/Dronabinol have already been on the market in the U.S. for decades, Epidiolex’s active ingredient is unique in that it is a “formulation of CBD. What sets the drug apart is that it is based on the plant itself rather than a synthetic compound.”3 Several states have legalized CBD oil for the treatment of epilepsy, but it is not legalized at the federal level.4
The issue surrounding Epidiolex is that it cannot yet be marketed in the U.S. because marijuana is classified under the Controlled Substances Act (CSA) as a Schedule I substance. Schedule I substances are deemed to have no medical value and a high potential for abuse and therefore cannot be an ingredient in a prescription medication.5
Despite this hurdle, Epidiolex’s U.K.-based manufacturer, GW Pharmaceuticals, expects to make the drug available in the U.S. after the Drug Enforcement Administration (DEA) assigns it a new controlled-substance classification; the decision is expected by late September.6 DEA public affairs officer Barbara Carreno told Business Insider in a recent interview that CBD will soon be categorized as a Schedule II or III drug.7
The FDA approval/DEA reclassification process works as follows: the FDA provides recommendations to DEA regarding controls under the CSA; once DEA receives such a recommendation, DEA is “required to make a scheduling determination.”8 While the scheduling determination does lie within the control of DEA, it appears highly unlikely that DEA would refuse to change a scheduling once the FDA has approved a drug. GW Pharmaceutical’s CEO Justin Gover expects that rescheduling will be completed within 90 days from FDA approval, which he says is the standard time window for DEA to make a rescheduling decision after FDA approval has been issued.9
What does this mean for employers?
Many employers are asking how a first marijuana-based prescription drug will impact employee drug testing. If you have an employee taking Epidiolex, how should you treat a positive marijuana result?
Unfortunately, the answer isn’t quite clear. When/if the DEA re-schedules Epidiolex, we’ll have to see if they provide guidelines for employers. We’re in new territory here, and so far, there has been no clarification as to how this would impact employers from the DEA. If the DEA reschedules CBD, then this specific drug, as one that is approved by the FDA, would likely be included as a protected prescription. Despite Epidiolex already being approved by the FDA, it is in a legal gray area because CBD is still a Schedule I drug.
As laws continuously change regarding the legalization of marijuana and CBD substances, it is absolutely vital for employers to remain in-the-loop as possible regarding these substances and the laws impacting them. If the DEA reschedules, and if they issue guidance for employers, DISA will continue to keep our customers updated with the latest drug testing related news.
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