For the first time the FDA has issued approval of a cannabis-based medication. The drug has proven to be an effective means of treating rare forms of epilepsy.
The drug, called Epidiolex, is produced by the UK-based GW Pharmaceuticals and is made from the non-psychoactive cannabis compound CBD. While the medical applications of CBD have become increasingly accepted in the medical community, the FDA approval is a landmark moment for medical marijuana. Previously, drugs comprised of synthetic THC have been approved by the FDA but the approval of Epidiolex serves as the first of its kind for cannabis derived medications.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," said FDA Commissioner Scott Gottlieb during a call with reporters about the approval.
With FDA approval comes a couple of things. Foremost, says pediatric neurologist Robert Carson, is patient access to high-quality and consistent medications. While CBD has been widely available in dispensaries across the US, they were not subjected to the same standards that an approved medication is.
"Our biggest concerns with the artisanal [or supplement] versions of CBD were related to the consistency," Carson says. "We can't guarantee the consistency."
Carson says Epidiolex is a drug he is prepared to prescribe to epilepsy patients moving forward. "I'm always excited about the potential for a new therapy that has been well-studied and has a great potential for benefit."
Of course, there is one other massive change that comes with FDA approval: DEA rescheduling. Cannabis is currently classified as a Schedule I substance—a drug that has no medical use and high abuse potential—and sits alongside the likes of heroin. As Douglas Throckmorton, the deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research, says FDA approval of Epidiolex means the DEA will be forced to change the scheduling of CBD.
"The DEA will need to make a different scheduling decision for CBD...because it now has an accepted medical use."
While the whole cannabis plant will continue to be a Schedule I substance for the time being, the medical acceptance of CBD by the federal government is a step in the right direction for cannabis reform.