The DEA has asked the FDA to consider rescheduling marijuana.
As I write this column, the Drug Enforcement Administration (DEA) has requested that the FDA take a look at rescheduling marijuana to change its current status as a CI controlled substance. Apparently, the DEA has requested this more than once in the recent past, and each time, the FDA has decided to keep marijuana in the same class of drugs.
The FDA considers 8 factors when deciding whether marijuana should maintain a CI status or be given one of the other 4 schedules for prescription drugs:
The actual or relative potential for abuse of the drug
Scientific evidence of the drug’s pharmacologic effect, if known
The state of current scientific knowledge regarding the drug or other substance
The drug’s history and current pattern of abuse
The scope, duration, and significance of abuse of the drug
What, if any, risk the drug poses to public health
The drug’s psychic or physiologic dependence liability
Whether the drug is an immediate precursor of a substance already controlled under this subchapter
I saw quotes from some pro-marijuana enthusiasts saying that the DEA’s request was a step in the right direction. Some of them feel that the government is softening its stance on this controversial drug, but if the drug approval process is the same for all pharmaceuticals, marijuana will have several problems. One of the initial problems is how any manufacturer could provide identical potencies to satisfy the FDA. Then marijuana would have to go through all the review stages that prescription medicines must go through for approval.
If this could be accomplished, marijuana could be rescheduled. Would the schedule be CII, CIII, or CIV? Or would marijuana be a noncontrolled substance? Regardless, it would still require a prescription to be ordered by a licensed prescriber, but where would the prescription be filled? At a licensed pharmacy by a licensed pharmacist, of course. I assume that this is how it would be handled, as with all other legal pharmaceuticals in the United States today, but I never thought I would see the federal government decide not to enforce laws.
Also happening recently, New York became the proud legalizer of medical marijuana, making it the 23rd state to do so—regardless of the negative events in Colorado and California, 2 of the initial states to offer medical marijuana.
I think there is no doubt that more uses of tetrahydrocannabinol are being found every year to very possibly address a slew of diseases in humans. This is a very good thing, and something we should all support. For instance, GW Pharmaceuticals’ Sativex is a cannabinoid for treating multiple sclerosis and may have other uses, such as cancer pain management. However, none of these promising drugs can be rolled into a joint and smoked!
Be on the lookout for the 2014 Rocky Mountain High-Intensity Drug Trafficking Area report on legalized marijuana in Colorado. Scheduled for release sometime in August, it provides a summary of the collaborative damage that legalizing marijuana is causing in that state. I referenced the 2013 report that detailed the huge increase in marijuana-related fatal auto accidents in a prior column (http://bit.ly/1wc9G7G). My task force provided a contribution when 5 of our Ohio residents rented homes in Colorado and promptly became medical marijuana patients. This permitted them to each grow plants for their “medical” issues and buy surpluses from dispensaries, allowing them to send approximately 500 lb of hydroponic marijuana back to southwest Ohio for sale at $4000 to $5000 per lb, per month.
It will be interesting to see if the FDA complies with the DEA’s request this time. If the FDA does, what happens next? Don’t look for a quick decision by the FDA. The federal government moves slowly most of the time, and I don’t see this being an exception.
Cmdr Burke is a 40-year veteran of law enforcement and the current president of the National Association of Drug Diversion Investigators. He can be reached by e-mail at firstname.lastname@example.org or email@example.com or via the website www.rxdiversion.com.