A growing body of research suggests that cannabidiol (CBD) can reduce seizures in individuals with epileptic disorders, reducing the damage caused by these diseases as well as improving quality of life. Importantly, the drug company GW Pharmaceuticals has developed a process to extract CBD in pure form, thereby removing the psychoactive and potentially addictive effect of consuming marijuana. This CBD extract-based medication has yielded positive results in clinical trials with children suffering from forms of epilepsy such as Dravet Syndrome and Lennox-Gastaut Syndrome.
Now, the CBD extract is currently being considered for approval as a medication by the Food and Drug Administration, which would pave the path for doctors to prescribe it.
To legally approve a medicine, the FDA must have specific information on what it contains and in what specific doses. The FDA could thus never approve the whole marijuana plant as a medicine because there are many different combinations of chemicals in different concentrations from strain to strain, plant to plant, and even from one part of the same plant to another. However, a pure CBD extract that could be dosed in a standardized manner would be a different matter, and there is no barrier to the FDA going forward.
Assuming the FDA approves CBD extract as a medicine, the Drug Enforcement Administration would then have to agree to remove CBD from Schedule I of the Controlled Substances Act, which is where it now sits by virtue of being part of an illegal drug with no officially recognized medical use (marijuana). Would the DEA really consent to scheduling as a legitimate medicine an extract of a plant they have spent decades battling?
Based on a recent announcement in the Federal Register, the answer appears to be yes. The DEA is creating a separate classification for scheduling cannabis extracts, and specifically mentioned CBD as a potential example. The resulting legal framework would seem to allow CBD-derived medications to move to a less restrictive schedule while leaving marijuana on Schedule I.
Even if that were to happen, however, hurdles would remain for getting the medication into the hands of those who need it.
States would have to agree to mirror the federal schedule change in state-level drug scheduling, which could be contentious in some states and bureaucratically slow in others. One California legislator is trying to avoid those problems. Jim Wood, chair of the California Assembly’s Health Committee, has introduced legislation that would reschedule CBD medications in California the moment that the federal government does likewise.
If passed, Wood’s legislation will eliminate delays between any future approval of CBD medications and the medication’s availability to California patients. Otherwise, Wood notes “a new bill would have to go through the entire legislative process and then get signed by the Governor.” Wood doesn’t want the normal legislative grind to slow down the rate at which “doctors can prescribe and pharmacists can dispense FDA-approved epilepsy treatments derived from CBD.” The more than 5 million Americans who suffer from epilepsy would almost certainly agree.