FDA OKs First Marijuana-based Drug


Epidiolex becomes the first-ever cannabis-based drug approved by the FDA. The drug is used for treating seizures associated with two rare and severe forms of epilepsy. GW Pharmaceuticals/Greenwich Biosciences

The slow but seemingly inexorable slog toward acceptance of marijuana in the American mainstream took a major step forward in June, when the U.S. Food and Drug Administration (FDA) for the first time approved an epilepsy drug that is derived from the cannabis plant. The FDA is part of the government that still, legally, considers marijuana on a par with heroin and LSD.

A couple days later, Oklahoma passed a voter-backed law that allows physicians to use their discretion in prescribing medical cannabis. The Sooner State became the 30th state to OK medical marijuana use.

As July dawned, Vermont became the ninth state to legalize pot for recreational use. (Washington D.C. allows it, too.) Vermont, notably, was the first to do so by an act of the legislature. Every other state so far has approved it in through a referendum of the voters, which isn't an option in the Green Mountain State.

Those were all news-breaking events in the decades-old move to legalize marijuana, but none may be more significant than the FDA's June 26, 2018 final approval of the epilepsy drug Epidiolex. The FDA authorized Epidiolex for a specific use: To treat two forms of severe epilepsy. Many see that endorsement — the first legal use of a derivative of a plant that is illegal — as a critical step, though not necessarily the final, winning move.

It is, however, a definite win for the families whose children with epilepsy have been fighting for this treatment. "This approval is the culmination of GW's many years of partnership with patients, their families and physicians in the epilepsy community to develop a much needed, novel medicine," Justin Gover, GW Pharmaceuticals chief executive officer, said in a press statement. "These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."

Paul Armentano, the deputy director of NORML, the National Organization for the Reform of Marijuana Laws said in a statement that he anticipates Epidiolex to be the first of many cannabis-based drugs approved by the FDA. "Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis — a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states."

The approval of Epidiolex, in addition to possibly paving a future for the regulation of herbal cannabis, could show more immediate results if it leads to the approval of marijuana and more marijuana-based products on the medical front. Atlanta neurosurgeon and CNN medical correspondent Sanjay Gupta points to growing research that marijuana could help break the grip of the opioid addiction. It's also a proven pain reliever. It reduces inflammation. More research is being done.

A major obstacle remains, though. Marijuana still is a Schedule I drug, which not only criminalizes its use on a national level but restricts federal money so critical to research. The hope, among those advocating for the decriminalization of marijuana, is that the sanctioning of Epidiolex will force the government to move marijuana out from among Schedule I drugs.

If the first half of 2018 is any indication, that may be just a matter of time, despite some stonewalling by those at the highest level of the government. Marijuana, once thought to be a blight on society, may yet get a chance to show its benefits to it.


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