The Food and Drug Administration’s approval of a new prescription anti-seizure medication derived from cannabis just might be the nudge another federal agency needs to reclassify marijuana and allow much more research into its potential benefits — and any risks.
After extensive clinical trials, the FDA on Monday approved the new drug, Epidiolex, to treat two rare forms of epilepsy that cause severe seizures that are resistant to existing anti-seizure medications. The medication contains cannabidiol (CBD), one of the two main components of cannabis. The other, delta-9 tetrahydrocannabinol (THC), produces the “high” sought by recreational marijuana users. CBD does not.
Despite this step by the agency responsible for regulating prescription drugs in the United States, the Drug Enforcement Agency continues to list marijuana as a Schedule 1 controlled substance, on the grounds that it has a high potential for abuse and no known medical use.
Now, there is a known medical use, at least for CBD derived from marijuana. Before the new drug can be sold in the U.S., the DEA must reclassify CBD, at least to Schedule 2, which includes methamphetamine, cocaine and opioids, all of which have known medical uses along with their high potential for abuse.
The agency has 90 days to decide. It could declassify marijuana in general, or approve only CBD oil for pharmaceutical but not recreational use.
A great deal of money rides on the decision. Estimates of the new drug’s retail price range from $2,500 to $5,000 a month.
It should not escape the Trump administration’s notice that the profits from the new drug would go not to an American company but to GW Pharmaceuticals, the British firm that developed it. The marijuana it was derived from was grown in the United Kingdom with that government’s blessing.
The reality is that American drug manufacturers cannot do the kind of research and development of potential marijuana-derived drugs that GW did because federal law bars them from growing marijuana for research purposes. Reclassifying marijuana would remove that restriction.
Although 29 states have legalized medical marijuana and nine have legalized recreational use by adults, much is unknown about marijuana’s effects and its medical potential, largely because research is so tightly restricted. The DEA should reclassify marijuana and allow this country’s scientific and business communities to find the answers to those questions.