The U.S. Department of Justice and Drug Enforcement Administration announced on September 27, 2018 that Epidiolex, a cannabis-based drug approved by the Food & Drug Administration, is being placed in Schedule V of the federal Controlled Substances Act, the least restrictive schedule of the CSA. This is the first time that any marijuana-based drug has been approved by a federal agency for lawful medical use.
As we discussed in our earlier blog post, the FDA announced in June that it approved Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex contains cannabidiol (CBD), a chemical component of the cannabis plant (otherwise known as marijuana). The CBD in Epidiolex is extracted from the cannabis plant and is the first FDA-approved drug to contain a purified extract from the plant.
Under the federal Controlled Substances Act, marijuana (including CBD) currently is classified as a Schedule I drug. The CSA categorizes drugs into five categories depending on the drug’s acceptable medical use and the drug’s abuse or dependency potential. Schedule I drugs are defined as drugs with no currently accepted medical use and a high potential for abuse. Schedule I drugs are considered the most dangerous and include marijuana, heroin, LSD and Ecstasy, among others.
It is possible that the scheduling of Epidiolex as a Schedule V drug could be a first step toward the eventual reclassification of marijuana. In 2016, the DEA denied petitions to reschedule marijuana from a Schedule I drug to a Schedule II drug, because the research did not yet support a reclassification. At that time, the DEA stated that the current medical and scientific evidence demonstrated that marijuana has no currently accepted medical use in treatment in the United States. It appears that the DEA may be changing its position. In today’s announcement, the DEA stated that “marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use.”