As previously reported by CNBC and Business Insider, a new drug derived from cannabis has led to a landmark change in the U.S. government’s stance on marijuana.
CBD Drug Treats Childhood Epilepsy
The drug, Epidiolex, is designed to treat two rare forms of childhood epilepsy using cannabidiol, or CBD, the compound in marijuana not responsible for a high. The latest move means people can now access the drug with a doctor’s prescription.
Epidiolex was greenlit by the FDA as the first federally-approved cannabis-based medication at the end of June. This triggered the nation’s top drug enforcer to change how it regulates marijuana.
It’s the first time in 46 years that the agency has shifted its stance on a marijuana compound.
90-Day Countdown Expired
The Drug Enforcement Administration announced the classification changes of Food and Drug Administration-approved drugs containing CBD on Thursday, roughly three months after the FDA approved Epidiolex as a medication.
When the FDA approved Epidiolex in June, it triggered a 90-day countdown clock for the DEA to change its stance on marijuana.
Reschedule? “We Don't Have a Choice”
When asked about the rescheduling of Epidiolex and other FDA-approved CBD drugs, DEA public-affairs officer, Barbara Carreno told Business Insider that, "CBD, absolutely has to become Schedule II, III, IV, or V." She went on to tell Business Insider that, “We don’t have a choice on that.”
Some cannabis researchers expected the DEA to reschedule CBD completely, but that’s not exactly what happened. Instead, the DEA chose to reschedule drugs containing CBD that the FDA has already approved; those drugs will now be classified as Schedule V.
Though the DEA typically does not pursue or enforce the law, individual users, popular CBD balms, oils, lotions, and salves are still Schedule I drugs and therefore illegal under federal law, a DEA spokeswoman told CNBC.
Schedule 5 drugs are those considered to have the lowest abuse potential and include drugs like cough syrups made with codeine. This would put CBD four rungs lower than its source plant, cannabis, which is still classified as Schedule I.
Since the FDA has only approved one CBD drug, at the moment, the only drug that fits the description is Epidiolex.
Potential Avalanche of New FDA Applications
Industry experts say the approval could unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.
In a previous interview, Barbara Carreno told Business Insider that a rescheduling would trigger what she called a “sea change” for CBD manufacturers and the industry as a whole.
As new CBD medications apply for approval, they may find that FDA testing is quite rigorous. “The main thing is that CBD, as approved by the FDA, is pharmaceutical-grade CBD. It’s manufactured under stringent standards, the same as other FDA-approved drugs,” Shlomo Shinnar, president of the American Epilepsy Society, told Business Insider.
More Research into Cannabis
Epidiolex’s approval could also be a powerful catalyst for deeper research into other marijuana-derived medicines. CBD and THC are two of the more than 400 known compounds in cannabis, and researchers think the others could hold promise as well.
Although Epidiolex is the first marijuana-plant-based drug to land FDA approval, the agency has already given the green light to drugs whose active ingredient is a synthetic, lab-made version of THC.