On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention. The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals. The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found in cannabis that is not considered psychoactive. If approved, Epidiolex would have orphan drug status, meaning that it is marketed to treat rare diseases or conditions, in this instance rare forms of epilepsy. FDA is not bound by the advisory committee recommendations, but often follows them.
With Epidiolex’s approval likely looming, one question is what the impact will be on the CBD dietary supplements currently on the market. FDA has made clear that it does not believe that CBD can be legally marketed as a dietary supplement because of GW Pharmaceuticals’ initiation of investigational new drug applications for its products prior to CBD being marketed as a supplement. Further, FDA has issued numerous warning letters relative to CBD labeled as dietary supplements but that contain little or no actual CBD as well as those that feature express disease treatment claims. Will the approval of Epidiolex impact those CBD products currently sold as supplements? Almost certainly, the answer is yes. Epidiolex would be the first product determined to be safe and effective for treatment of these rare forms of epilepsy available nationwide. Currently, CBD availability is subject to a patchwork of state regulations, prohibiting access to people in states that restrict it and creating risk in crossing state lines to obtain it. While approval of Epidiolex would address that issue, its cost and prescription-only status may mean it remains out of reach for some consumers. It’s also foreseeable that, with an approved drug on the market, we see increased regulatory enforcement on other products.
Administrative and Legislative Shifts
Also under the category of expanded access, the Trump administration reportedly has reached an agreement with Colorado Senator Cory Gardner (R) to forego cannabis enforcement in states where it is legal. Last but not least, Senator Chuck Schumer (D-NY) confirmed that he is adding his name to a bill to decriminalize marijuana at the federal level. As reported by NPR, it would remove marijuana from the list of scheduled substances, establish funding for women- and minority-owned marijuana businesses, require more research on the drug’s public health impact, and maintain federal authority to regulate commercial advertising, similar to existing regulations for tobacco and alcohol. Senator Schumer did not provide a date on which the legislation will be introduced. Undoubtedly, much debate to follow.