FDA’s Relationship with Marijuana: It’s Complicated

By Elizabeth Guo

Marijuana and marijuana-derived products are top of mind for state legislatures these days. On March 10, the Virginia state legislature passed a bill legalizing cannabidiol oil, a marijuana-derived product, for patients who suffer from epilepsy. Other legislatures are actively debating measures to legalize cannabis-related products in their states, and many of these legislative proposals would allow cannabis-use for patients suffering from specific medical conditions. Last week, the Alabama state legislature debated a bill that would allow people to take cannabidiol to treat certain conditions, and Utah recently defeated a bill that would have allowed people with certain debilitating conditions to use a marijuana-related extract.

As more states pass bills allowing patients to use marijuana-derived products, will state laws clash with federal policies implemented by the Food and Drug Administration (FDA)?

Marijuana is complicated. Marijuana refers to the dried leaves and flowers of the cannabis plant. All marijuana plants contain a mixture of molecules, including cannabinoids. Different cannabinoids can have different effects, and scientists have identified more than 200 different cannabinoids from marijuana plants. Some of the most well known cannaboids in marijuana include tetrahydrocannibonol (THC), cannabidiol (CBD), and archidonoyl ethanolamide (anandamide).

Under federal law, marijuana and most marijuana-derived substances have no medical use, which is why the Drug Enforcement Administration (DEA) classifies marijuana as a Class I controlled substance. However, in recent years, research suggests that marijuana and marijuana-derived products may have medical benefits. Evidence suggests that marijuana can be an effective treatment for chronic pain, nerve pain, and muscle spasms for multiple sclerosis. Cannabidiol may also reduce seizures for children with epilepsy.

Unfortunately, few drug companies have invested the research and time to conduct large, well-controlled trials on the medical benefits of marijuana-derived products, which is why FDA has approved few marijuana-derived products to date. The lack of marijuana-derived drugs has encouraged states to take matters into their own hands. Twenty-two states and the District of Columbia have legalized medical marijuana. Sixteen other states have legalized marijuana-derived products with varying restrictions, usually reserved for individuals suffering from chronic disease. For example, Alabama allows the University of Alabama to conduct research using marijuana-derived products for treating seizure disorders. Florida, however, allows marijuana-derived products to relieve symptoms from cancer, medical condition, or other seizure disorders.

Drug companies are not far behind. GW Pharmaceuticals recently announced results from its phase 3 clinical trial that its marijuana-derived product significantly reduced the number of seizures for patients with Dravet syndrome, a rare and debilitating type of epilepsy. Insys Therapeutics has also received an orphan drug designation for its pharmaceutical cannabidiol compound to treat Dravet. If and when cannabidiol drugs hit the market, how will FDA treat marijuana-derived products already on the market that patients now use to ease their symptoms? Historically, FDA has not targeted marijuana-derived products for marketing violations, but in 2015, FDA issued six warning letters to firms marketing cannabidiol to treat disease. Recently, FDA issued eight warning letters to manufacturers marketing cannabidiol. These enforcement actions are likely to continue and may intensify once a FDA-approved cannabidiol drug reaches the market.

This is all to say that issues surrounding medical marijuana and marijuana-derived products will likely become more complicated as marijuana-derived drugs hit the market. FDA cannot force cannabidiol products off the market, but it seems unlikely that patients will stop buying cannabidiol oil once FDA approves a cannabidiol drug. States will also have to decide whether to keep its cannabidiol laws on the books once FDA approves a cannabidiol-based drug. Physicians will need to choose between prescribing cannabidiol drugs and recommending marijuana-derived products when the latter will likely be cheaper. None of these choices will be resolved any time soon.

This entry was posted in Criminal Law, Elizabeth Guo, FDA, Food Safety, Health Law Policy, Medical Marijuana, Pharmaceuticals by Elizabeth Guo. Bookmark the permalink.

About Elizabeth Guo

Elizabeth Guo is a third year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie in food and drug law, at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Elizabeth has worked at the Food and Drug Administration and at the Multi-Regional Clinical Trials Center. Prior to law school, she was a senior associate at Avalere Health, working with life science clients on health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs.