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The Coexistence of FDA Approved Cannabis-Based Drugs and Medical Marijuana Provided through State-Licensed Businesses

 

The difference between marijuana and cannabis often leads to confusion. Technically, the correct botanical name for the plant is cannabis. However, it is commonly referred to by a variety of slang or local names,  depending on the country or region.

 

The word marijuana only entered America’s popular vocabulary in the early 1900s and then began to refer to the cannabis plant that provided psychoactive effects. Today, in North America, France and parts of Latin America, the plant is commonly referred to as marijuana, but in much of the rest of the world, it is known as cannabis.

 

When referring to the plant for its medical benefits, I find it useful to refer to it as marijuana, when grown, produced or sold through state-licensed businesses. I also find it beneficial to refer to cannabis-based medicine for drugs that are seeking approval from the U.S. Food and Drug Administration (FDA).

 

My recent article regarding the impact of the Drug Enforcement Administration’s (DEA) possible rescheduling of marijuana generated more comments than any article I had previously written. Many patients relying on marijuana-based medicine voiced concern that if the DEA reschedules marijuana, that they will be deprived of their medicine. Owners and employees of state-licensed medical marijuana businesses voiced concern that a federal rescheduling of marijuana would force a closure of their businesses.  I don’t believe that either is likely.

 

Equally of concern to both patients and state-licensed marijuana businesses are the implications of the likely approval of GW Pharmaceuticals’ Epidiolex, a cannabis-based drug, by the Food and Drug Administration. Research announced by GW Pharmaceuticals indicated that Epidiolex reduced seizures in children suffering from Dravet Syndrome, a rare and severe form of epilepsy, by 39 percent.  It’s likely that GW Pharmaceuticals will seek approval from the FDA later this year to market Epidiolex, with the drug being available to consumers by the end of next year.

 

Many parents of children who have Dravet Syndrome, who rely on marijuana-based medicine are concerned regarding what happens once the FDA approves Epidiolex. Will they be forced to switch to Epidiolex, or can they continue to purchase medical marijuana from state-licensed businesses?

 

Likewise, many owners and employees of state-licensed marijuana businesses are concerned that once the FDA approves Epidiolex, as the first plant-derived, cannabis-based medicine, that their businesses will be forced to close.  

 

The Implications of GW Pharmaceuticals Obtaining FDA Approval for Epidiolex

 

If the FDA approves the marketing of Epidiolex, it will not directly affect state-licensed medical marijuana businesses.

 

I’ve been asked whether state-licensed medical marijuana businesses will be forced to employ pharmacists and whether medical marijuana will have to be produced in accordance with pharmaceutical manufacturing standards.  Neither will occur.

 

If Epidiolex is approved by the FDA, there will be a plant-derived, cannabis-based medicine available for only one initial condition, Dravet Syndrome.  Epidiolex will not be marketed or available through state-licensed marijuana businesses, but instead through normal pharmaceutical distribution channels, including pharmacies such as Walgreens and Rite Aid.  

 

I have also been asked what happens to children suffering from Dravet Syndrome, who are currently obtaining their medicine from state-licensed marijuana businesses.

 

When the Federal Food, Drug, and Cosmetic Act, a series of laws passed by Congress, was enacted in 1938, it authorized the Food and Drug Administration to oversee the safety of food, drugs, and cosmetics, including plant-based and herbal medicine. Despite the responsibility to do so, the FDA has chosen to avoid regulating some plant-based medicine, including traditional Chinese herbal medicine. The FDA has also avoided regulating state-licensed marijuana businesses, which under the Act the agency clearly has the authority to regulate. I don’t believe that the FDA has any desire to regulate state-licensed marijuana businesses. It would be a political nightmare for the FDA.

 

But, there could be ramifications from GW Pharmaceuticals obtaining FDA approval for Epidiolex. GW Pharmaceuticals could seek to protect its intellectual property, consisting of both patents and the FDA approval, by taking legal action against state-licensed marijuana businesses that are manufacturing or selling a marijuana-based medicine for Dravet Syndrome.

 

Once Epidiolex is approved by the FDA, the agency could also seek to prohibit state-licensed marijuana businesses from selling a marijuana-based formulation for Dravet Syndrome.

 

It’s important to realize that these possible actions by either GW or the FDA would likely only relate to the use of medical marijuana for one condition, Dravet Syndrome.

 

The Implications to State-Licensed Marijuana Businesses from the Rescheduling of Marijuana

 

The scheduling of drugs originated more than 45 years ago with the signing into law of the Controlled Substances Act of 1970. The Act allowed Congress or the applicable government agencies, to “schedule” substances based on their medical value, safety, as a medical treatment and their potential for abuse. Under the Act, the government assigns drugs to specific schedules and can reschedule a drug.

 

Currently, marijuana is a Schedule I substance, based on the federal government's view that the plant provides no medical benefit and has a high potential for abuse. Under federal law, no Schedule I substance, including marijuana or cannabis, can be legally purchased in the U.S.

 

The Drug Enforcement Administration (DEA) has indicated that it will rule on the rescheduling of marijuana sometime this summer. Over this past weekend, unconfirmed rumors indicated that the FDA would reschedule marijuana to Schedule 2 on August 1st.

 

Concerns have been raised that if marijuana is rescheduled by the FDA, it will result in the closure of state-licensed marijuana growers, extractors, edible product manufacturers, and dispensaries. This will not be the case. Forced closures will not occur as a result of a rescheduling of marijuana.

 

The existence of state-licensed marijuana programs is not based on marijuana's schedule.  Instead, the ability of states to allow and license marijuana businesses derives from a series of federal executive actions, the most important of which were the Cole and Ogden memoranda. These executive actions allowed state marijuana programs to exist as long as they were not at odds with certain Department of Justice objectives, including the trafficking of marijuana by drug cartels and the sale of marijuana to minors

 

The Obama administration used executive orders to allow state-licensed marijuana programs to exist by de-prioritizing the provisions of the Controlled Substances Act. The de-prioritizing of marijuana is what the Cole and Ogden memoranda accomplished.

 

I don’t foresee any impact from rescheduling on state-licensed marijuana businesses.  

 

My Conclusion

 

The rescheduling of marijuana by the DEA and the approval by the FDA of Epidiolex would both be monumental. Either of these actions will finally indicate that the U.S. government acknowledges that there are medical benefits to be derived from the cannabis plant. The actions will also bring credibility to America’s marijuana industry and result in an increase in investor interest in the industry.

 

The likely FDA approval of Epidiolex, as the first U.S. approved plant-based cannabis medicine will be very significant. It will provide formal acknowledgment by the U.S. government that there are medical benefits of derivatives from the cannabis plant, even if Epidiolex is only approved for the use of one medical condition, Dravet Syndrome. For the first time, there will be an FDA approved medicine that can legally be prescribed by doctors and which will be available at traditional pharmacies.  

 

I see the two systems; FDA approved cannabis-based drugs distributed through pharmacies; and medical marijuana sold through state-licensed businesses to co-exist for many years.  Patients who are dependent on medical marijuana should not be concerned that they will be deprived of their medicine. Likewise, owners and employees of state-licensed marijuana businesses should not worry that the FDA will force them to cease operations.  

 

Copyright 2016 Jeffrey Friedland


Jeffrey Friedland is the author of “Marijuana: The World’s Most Misunderstood Plant,” which is available in print and Kindle editions at Amazon.

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