- The nation’s top drug regulator has officially changed how it regulates CBD, a marijuana compound in a new epilepsy drug called Epidiolex.
- This is the first time the Drug Enforcement Administration has shifted its stance on cannabis in 46 years.
- The DEA’s move comes nearly 90 days after Epidiolex was green-lit by another government regulator at the end of June.
- Experts say the approval will galvanize research into other marijuana-based drugs.
A new marijuana-derived drug has led to a landmark change in the US government’s stance on cannabis.
After getting green-lit as the first federally-approved cannabis-based medication at the end of June, the drug has triggered the nation’s top drug enforcer to change how it regulates marijuana. It’s the first time the agency has shifted its stance on a marijuana compound in 46 years.
The drug is called Epidiolex and it 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 that patients can now access the drug with a doctor’s prescription — although it won’t be cheap.
The Drug Enforcement Agency announced the change to its classification of FDA-approved drugs containing CBD on Thursday, nearly three months after the Food and Drug Administrationapproved Epidiolex as a medication.
Some researchers expected the agency to reschedule CBD entirely. Instead, the DEA rescheduled FDA-approved medications which contain the compound.
Still, experts say the approval could unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.
‘We don’t have a choice on that’
When the Food and Drug Administration approved Epidiolex in June, it triggered a countdown clock for action from the Drug Enforcement Agency to change its stance on marijuana.
“We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider just after the FDA approved Epidiolex. CBD, she said, “absolutely has to become Schedule 2, 3, 4, or 5.”
That’s not exactly what happened. Instead of rescheduling CBD, the agency chose to only reschedule drugs containing CBD which the FDA has already approved. At the moment, the only drug that fits the description is Epidiolex.
For comparison, popular ADHD medication Adderall is classified one step down from marijuana in Schedule 2. That means that while it can be legally prescribed by a doctor, it still is considered to have “a high potential for abuse” or harm. Schedule 5 drugs are those considered to have the lowest abuse potential and include drugs like cough syrups made with codeine.
Since 1972, the DEA has kept a tight lid on cannabis. That year, Nixon-era Attorney General John Mitchell named it a Schedule 1 drug “with no currently accepted medical use” — making all of its components, from psychoactive THC to non-psychoactive CBD, illegal.
But after the FDA green-lit Epidiolex, the Drug Enforcement Agency had 90 days to shift its position.
Carreno previously told Business Insider that the change would trigger what she called a “sea change” for CBD manufacturers and the industry as a whole, which up until now has existed in a kind of legal grey area with some manufacturers selling marijuana-derived CBD products only in states where marijuana had been legalized. It’s unclear whether that will happen now with the agency’s move.
Epidiolex vs. other CBD products
Scientists and advocates representing families of patients with epilepsy have hailed Epidiolex’s arrival as a long-awaited treatment.
But they are also aware that desperate patients — especially parents of young children — may actively seek alternate sources of CBD that may be cheaper and don’t require a doctor’s prescription. In August, GW Pharmaceuticals, the company that makes Epidiolex,announced on a call with investors that the drug would cost roughly $32,500 per year.
In states where marijuana is legal (or in states with laws that had made CBD legal before the DEA rescheduled it), less expensive CBD-based oils and salves are widely available. But experts caution that these products may not be what they seem.
“What’s different with [Epidiolex] is that this is a well-studied and well-controlled product,” Lubbers said.
By contrast, most dispensary-grade CBD products are not well-studied or well-controlled.
For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 products purchased from 31 different online CBD sellers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items they tested, roughly half of the items had more CBD than was indicated; a quarter had less. And 18 of the samples tested positive for THC, despite it not being listed on the label.
“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, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine, told Business Insider in June.
A catalyst for more research into marijuana-derived drugs
Epidiolex’s approval could also be a powerful catalyst for deeper research into other marijuana-derived medicines. Cannabis has more than 400 compounds. CBD and THC are two of those compounds, and researchers think the others could hold promise as well.
Apart from CBD, researchers are also actively studying THC and other marijuana compounds for a range of potential medical uses, from relieving pain to soothing severe nausea. 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 lab-made version of THC, for example.
In the meantime, experts look forward to seeing Epidiolex made available to patients in need.
“I’m not currently aware of any other major new drugs that are close to being where this drug is,” Shinnar said.