How FDA Approved Cannabis Products Could Affect CBD Distribution Channels

Last week, GW Pharma (NASDAQ: GWPH) scored a milestone victory, as the thirteen-member panel at the Peripheral and Central Nervous System Drugs Advisory Committee, which met on April 19th to consider the safety and efficacy of Epidiolex, its CBD-based product, and pass along its conclusions to the FDA, gave it a unanimous decision in favor of Epidiolex. The committee, which referred to Epidiolex as “Cannibidiol Oral Solution” (CBD-OS), saw it as safe and efficacious in treating seizures in patients 2 years of age and older suffering from Lennox-Gastaut syndrome and Dravet syndrome. The FDA is expected to complete its review process of the Epidiolex New Drug Application by June 27th. If approved, Epidiolex will be the first cannabis-derived FDA-drug approved.
Clearing a Big Misconception

Many are curious about how FDA approval of a cannabis-derived medicine will impact scheduling of cannabis, which is a Schedule 1 controlled substance having “no currently accepted medical use and a high potential for abuse,” according to the Drug Enforcement Agency (DEA). While the approval of Epidiolex will certainly lay the foundation for a challenge to the DEA scheduling of the underlying plant from which CBD is derived or even CBD itself, the DEA can schedule it differently from cannabis itself. GW Pharma expects the drug, if approved, to be Schedule 4, similar to many sleep or pain medications. The DEA will have up to 90 days upon FDA approval to schedule Epidiolex, assuming Health and Human Services provides it with a recommendation concurrently with the FDA approval.

The law further states that the 90-day time-frame starts the later of (1) the date DEA receives the HHS scientific and medical evaluation/scheduling recommendation or (2) the date DEA receives notice of the NDA approval by HHS. In addition, the law specifies that the rule-making shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause therefor.

Most recently, the DEA took more than 90 days to schedule Syndros, a synthetic THC oral solution developed by Insys Therapeutics, that was approved by the FDA on July 1, 2016. The DEA issued an interim ruling on March 23, 2017 that was finalized in late 2017, though this delay was likely because of the abuse potential of Syndros, a rapid-acting product, that required additional information.

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