Francis Palumbo Co-Authors Article on Challenges of Rescheduling Marijuana

Articles / August 30, 2018

Of Counsel Francis Palumbo co-authored an article published July 12, 2018, by the Health Affairs blog. The article, “Will the FDA’s Approval of Epidiolox Lead to Rescheduling Marijuana?,” explores the Food and Drug Administration’s (FDA) recent approval of the first cannabis-derived prescription drug, which treats two rare types of epilepsy that affect children. This is the first time the FDA has found a marijuana-derived drug to have an accepted medical use, which is one of the requirements for moving marijuana from a Class I to a Class II scheduled drug under the Controlled Substances Act.

The authors examine the background of this matter, the process for rescheduling of drugs and the hurdles facing sponsors seeking FDA approval for an herbal-based drug. They conclude:

The question remains, however, whether, if new drugs based on cannabis derivatives are approved, a market for pharmaceutical cannabis preparations and a less regulated market for herbal cannabis can coexist. We believe that the most appropriate way for this brave new world of state drug regulation to coexist with federal regulation would be for Congress to reschedule marijuana and mandate that the FDA regulate the botanical under a separate regulatory scheme, as it did for tobacco.

Read the article.