DEA changes its position on CBD
For the first time in 46 years, the U.S. Drug Enforcement Agency (DEA) has changed its position with respect to cannabidiol (CBD). However, there has been some confusing reporting on last week’s change by the DEA. So before you get too excited, read on….
On July 6, 2018, we warned the Food and Drug Administration’s (FDA) approval of GW Pharma’s (NASDAQ: GWPH) drug Epidiolex would force the DEA’s hand to change its treatment of cannabis.
On July 20, 2018 edition, we asked the following question: “What if the U.S. Drug Enforcement Administration (DEA) reschedules THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) but doesn’t reschedule cannabis?” We referenced the case of opium that is a Schedule 1 drug. For many years, the active ingredients of opium have been extracted and used in pharmaceutical products such as morphine, codeine, hydrocodone and oxycodone. In other words, there is a precedent for the DEA approving the chemicals derived from a drug while leaving the source a Schedule 1 drug and federally illegal. We concluded the only resolution to many of our problems with cannabis as a Schedule 1 drug is to reschedule or de-schedule cannabis at the federal level. Unless this happens, legalization in Canada will mean more people are at risk in relationships with the U.S. and that could include Canadian government employees after October 17, 2018.
The DEA actually did less than even we had hoped. Approval of a new drug in the U.S. requires the coordinated approval of both the FDA and DEA. So after the FDA approved Epidiolex, the DEA approved all drugs approved by the FDA that contain CBD made from cannabis plants and also have less than 0.1% THC. Such drugs will be changed to Schedule 5 drugs. Under the Controlled Substances Act (CSA), A Schedule 5 drug is one that “…has a low potential for abuse relative to the drugs in Schedule 4. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in Schedule 4.” Schedule 5 is the least serious drug ranking given by the CSA and still requires a doctor’s prescription. There are currently almost 100 Schedule 5 drugs.
This was the most restrictive approval the DEA could have given. Epidiolex is currently the only FDA approved drug that contains CBD and the only non-synthetic, cannabis-derived medicine approved.
Of course, we all know FDA approval can be a long and gruelling task. So this does not mean the floodgates have been opened. For example, GWPH was formed in the UK by two doctors in 1998 to pursue cannabis-based research. Pre-clinical research and trials continued until September 2013 when an initial Phase 1 started leading to FDA approval on June 25, 2018 and DEA approval last week. From start to finish, that’s over 21 years. This is a major challenge for all medicines that need FDA and DEA approvals and the FDA has already stated the approval of Epidiolex does not mean other approvals will be easier or faster.
Another issue that might arise is off-label prescriptions. Epidiolex is approved for a specific purpose. It is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. However, doctors sometimes prescribe drugs to treat medical issues other than what a drup is specifically approved for. For example, doctors may try to treat other epileptic seizures with this drug. At an estimated cost of $32,500 a year, it seems less likely but you never know for sure.
We don’t want to diminish the importance of last week’s Federal approval. It is the first time that any form of cannabis has been removed from Schedule 1. It is the first time a non-synthetic cannabis-related medicine can be prescribed by a doctor. It is the first time a non-synthetic cannabis-related medicine can be sold legally under U.S. Federal law. It is the first time that a non-synthetic cannabis-related medicine can be sold through a traditional pharmaceutical channel such as a drug store. As long as it is part of an FDA approved drug, CBD has gone from worst to first in terms of safest drug categories.
But it resolves very little other than allowing doctors to legally prescribe Epidiolex for their patients. It doesn’t make CBD or THC on their own legal. Cannabis remains a Schedule 1 drug. It does nothing for people working in the cannabis business. After Canada legalizes, it will still create challenges for cannabis workers to travel back and forth.