The credibility of cannabis as a source of a legitimate pharmaceutical ingredient in prescription medications took a major step forward in 2018 when the FDA approved Epidiolex (cannabidiol) for two types of severe seizures. Epidiolex was a stellar candidate for approval. It reduced convulsive seizures by about 40% and has a good safety profile. The advisory committee’s recommendation for approval was unanimous.
Epidiolex may turn out to be the trailblazer for more FDA-approved cannabis-derived drugs. It has triggered an important regulatory change that may lead to additional changes in 2019 that will spur drug development and also fuel the retail medical pot market.
Historically, drug development with cannabis has been severely curtailed by its classification by the Drug Enforcement Administration as a Schedule 1 highly restricted narcotic. Cannabis researchers must register and be approved by the DEA, and they must account for every fraction of an ounce of the drug they use. Likewise, physicians conducting clinical trials must be approved by the DEA and register their patients. The federal government also has ridiculous bureaucratic restrictions. The DEA allows only one individual at the University of Mississippi to grow cannabis for medical research purposes.
Epidiolex’s approval created a disconnect between the FDA and DEA and forced the federal government to reconsider its ban on prescribing cannabis-based drugs. The FDA sent a letter to the DEA outlining several reasons why Epidiolex’s active ingredient, cannabidiol, should not fall under the restrictions applied to narcotics. In September, the DEA reclassified Epidiolex as a Schedule V narcotic, which allows physicians to prescribe it without registration. But the DEA kept cannabis itself on Schedule I as a restricted narcotic.
The Trump administration has been sending mixed signals about its pot policy. On one hand, former Attorney General Jeff Sessions resisted any liberalization of laws against it. On the other hand, President Trump has said that he is open to reforms, such as states individually deciding to legalize marijuana.
“Everything in the marijuana industry is a moving target,” says Josh Horn, an attorney at Fox Rothschild who represents marijuana businesses. Nevertheless, Horn believes that there will be a fair amount of consolidation in the industry as it begins to mature.
Thirty-one states have legalized medical marijuana and nine states plus Washington, D.C., have legalized it for recreational use, notwithstanding federal law and rules. Horn says the federal government could take a half-step toward consistent, nationwide liberalization by removing restrictions on just cannabidiol, the active ingredient in Epidiolex. It is a different compound, tetrahydrocannabinol (commonly know by its initials, THC) that is responsible for the marijuana high. Cannabidiol is associated with most medicinal benefits but it does not generate psychoactive effects. A narrower federal OK for cannabidiol “would open up a new industry on a national basis,” in Horn’s view, and be an incentive for the larger drug developers to get into cannabidiol products and medications, including pain medications that might be an alternative to opioids.
Federal liberalization on cannabidiol may not be so farfetched. Horn says the 2018 farm bill includes a provision that would remove cannabidiol’s designation as a controlled substance. The FDA’s letter to the DEA about cannabidiol not being a narcotic is another indication that the tide may be turning. Regardless, 2019 stands to be an interesting, and perhaps pivotal, year for the mainstreaming of marijuana for recreational and medicinal purposes.