FDA Approves Cannabidiol, But Drug Still Faces Hurdles
By David Doolittle


The U.S. Food and Drug Administration (FDA) this week approved the first medication derived from marijuana, which could be used to treat two rare forms of childhood epilepsy.

Epidiolex is an oral solution that contains a pharmaceutical-grade version of cannabidiol, or CBD. It has been proven safe and effective in treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, FDA says.

But just because FDA has approved Epidiolex doesn’t mean physicians will be able prescribe it immediately. In fact, federal and state laws restrict who can prescribe CBD and how it can be marketed. 

CBD is non-euphoric and has low levels of tetrahydrocannabinol (or THC), the psychoactive element in marijuana.

It is currently a Schedule I substance under the federal Controlled Substances Act  and therefore cannot be marketed legally. For CBD to be rescheduled, the Drug Enforcement Agency (DEA) must determine whether its medical benefits outweigh its known and potential risks. The DEA is currently reviewing CBD for rescheduling and has 90 days to complete its review, FDA officials say. 

Using marijuana is illegal under federal law, but many states have legalized it for medicinal purposes. 

Texas is among a handful of states that permit CBD use for medical reasons, but the state’s laws are very restrictive. Only three dispensaries are licensed in Texas, and only about 30 Texas physicians are registered to prescribe cannabis oil.

The Texas Legislature paved the way for dispensing cannabis oil in 2015 by passing the Compassionate Use Act, which legalized only the sale of CBD. TMA at the time requested further study on the use of marijuana products as medicine. 

TMA policy on marijuana is not “an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.”

In its statement, FDA makes it clear that it has not approved marijuana or all of its components.

“This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” the FDA said in announcing the approval. “Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”   

Last Updated On

July 02, 2018

David Doolittle


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Dave Doolittle is editor of Texas Medicine and Texas Medicine Today. Dave grew up in Austin, where he attended culinary school as well as the University of Texas. He spent years covering Central Texas for the Austin American-Statesman newspaper. He is the father of two girls, a proud Longhorn, and an avid motorsports fan.

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