Hoosier Vapor’s Tiffany Jones talks about CBD oil. Kelly Wilkinson/IndyStar
The Food and Drug Administration on Monday approved the first-ever drug containing cannabis, potentially opening the door to another battle over the legality of over-the-counter¬†cannabidiol, or CBD, oil.
While Epidiolex received approval for treating seizures caused by two rare forms of epilepsy in patients over the age of two, doctors would also potentially be able to prescribe it for ‚Äúoff label use‚ÄĚ to address other conditions.
The drug will be available by this fall, said GW Pharmaceuticals in a statement.
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In the absence of a pharmaceutical form of the drug, the CBD oil industry in recent years has had many skirmishes with a number of states over the legality of products that contain cannabidiol derived from the cannabis plant.
Proponents say CBD oil can treat a range of conditions from epilepsy to anxiety.
In Indiana after much confusion over the legality of CBD oil, Gov. Eric Holcomb in March signed a bill allowing anyone to buy or sell the product as long as it had minimal amounts of the substance thought to produce the “high” associated with marijuana.
It was not immediately¬†clear Monday whether the FDA approval of a cannabis-based medicine would have any implications for the sale of CBD oil here.
Attorney General Curtis Hill, who issued an opinion in November deeming CBD oil illegal, welcomed Monday‚Äôs FDA decision, saying that standard scientific protocol should be followed when it comes to developing new medicines.
‚ÄúWe all long for breakthroughs in scientific research that help treat disease, illness and injury,‚ÄĚ Hill said in a statement. ‚ÄúThe appropriate path to these breakthroughs in the United States involves the FDA ‚ÄĒ¬†which approves a substance to be a medicine, outlines its legitimate prescribed use and provides guidance on proper dosage. Such a process is different from simply¬†labeling something as ‚Äėmedicinal.‚Äô ‚ÄĚ
Hill added that he would like to see any ‚Äúfurther forays‚ÄĚ into medicinal uses of marijuana to undergo the same process of review that Epidiolex underwent.¬† ¬† ¬† ¬†¬†
In a statement announcing the approval of Epidiolex, FDA Commissioner Scott Gottlieb said that his agency would continue to support rigorous research into the potential of medicines derived from¬†marijuana.
But the statement went on to say that the agency would take action if it saw illegal marketing of products with CBD oil that made unproven medical claims.
‚ÄúMarketing unapproved products with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,‚ÄĚ Gottlieb said.
Doctors welcomed the approval of another drug to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, a condition that until now has had no drugs to treat it.
Epidiolex might also prove helpful in treating¬†refractory seizures, which continue despite doctors trying at least two anti-seizure medicines, said Dr. Kelly Kremer, a pediatric neurologist with Riley Children’s Health.
Fewer than 10 of Kremer’s patients have one of the two conditions for which the drug was specifically approved but she said she has many patients who have refractory seizures for whom she might consider prescribing the drug.
While some patients with seizures may be purchasing CBD oil on their own, the new drug will come in known dosages, something that’s not guaranteed with non-FDA-approved CBD oil products, Kremer said.¬†
“This will be great,” Kremer said of the new drug. “It will remove a lot of these concerns that we have had.”
However, Epidiolex does not come without side effects. It can cause lethargy, diarrhea and elevated liver enzymes so those who take it should be carefully monitored and doctors should take the potential risks into account when deciding whether to prescribe it, Kremer said.
In addition, it’s not clear whether the drug might have cognitive affects that are unknown, she added. The drug was studied in a group of patients who have two conditions that lead to cognitive impairment, so its impact on those with typical cognitive abilities remains unknown.¬†
“It’s important for us (doctors) to make people know that it’s not side-effect free,” she said. “Part of the concern is that the appeal of the medication is the idea that it’s natural and that substances that are natural come with no side effects.”
The recently passed Indiana law requires all products sold containing CBD oil to have a QR code that links to information, such as the ingredients inside of the product¬†and the company‚Äôs name. In addition, the product must contain no more than .3 percent of THC.
Bobbie Young,¬†founder and president of IndyCann, a local group that advocates for medical marijuana, said she thought the FDA approval was both good and bad news for the budding cannabis industry and the many people who use CBD oil medicinally.
‚ÄúIt‚Äôs a win and in some ways, I feel it is a loss,‚ÄĚ she said. ‚ÄúYou realize, oh goodness, the stigma is going away. ‚Ä¶¬†But when you see Big Pharma stepping in, it kind of makes you feel that the farmers and little guys are being undercut.‚ÄĚ
Many questions remain unanswered, Young added, including whether doctors will actually write prescriptions for the drug and how much it will cost.
‚ÄúIt seems to me there‚Äôs a lot of loose ends around,‚ÄĚ she said.¬†¬†¬†¬†¬†
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