Medical milestone: US OKs marijuana-based drug for seizures

say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

The immediate impact of Monday’s approval on these products is unclear.

FDA’s Gottlieb warned about the use of CBD products with “unproven medical claims.”

“The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” Gottlieb said.

The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer’s. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

Industry supporters downplayed the impact of the FDA approval.

“I don’t know a mom or dad in their right mind who is going to change what’s already working,” said Heather Jackson, CEO of Realm of Caring, a charitable group that supports access to CBD. “I really don’t think it’s going to affect us much.”

Jackson’s group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few effective treatments. Patients experience frequent, severe seizures, in some cases more than 100 per day.

But doctors will have the option to prescribe it for other uses.

The new medication enters an increasingly complicated legal environment for marijuana.

Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

That decision is expected within 90 days.

GW Pharmaceuticals makes the drug in the U.K. from cannabis plants that are specially bred to contain high levels of CBD. And the company plans to continue importing the medicine, bypassing onerous U.S. regulations on manufacturing restricted substances. European approval is expected in early 2019.