By Nancy Tran
In light of the ongoing opioid misuse crisis, state and federal policymakers and health care experts are searching for new ways to effectively treat the ill. One area of growing interest among public and clinical health researchers alike is cannabis for medical use.
On June 25, the Federal Drug Administration (FDA) approved Epidiolex, a cannabidiol (CBD) oral solution used for the treatment of seizures associated with two severe pediatric epilepsy disorders. This is the third cannabis-derived drug to be approved by the FDA since the approval of Dronabinol and Nabilone in 1985. Unlike the other two, which contain synthetic versions of THC, Epidiolex is the first FDA-approved drug that contains purified cannabidiol, a nonpsychoactive substance derived from cannabis.
After the approval of Epidiolex, FDA Commissioner Dr. Scott Gottlieb released a statement expressing the importance of conducting well-controlled clinical trials to prove the safe and effective medical uses for active chemicals in cannabis and its components.
Cannabis is complex because there are more than 80 active components in the plant. Gottlieb said that like any other drug, there must be comprehensive research about whether a new compound is effective, safe, properly dosed and appropriate to treat specific medical conditions.
It may be a while before other FDA-approved cannabis-derived products are on the market. For health conditions such as multiple sclerosis, anxiety and pain, the progress for clinical research on cannabis has been slow. The lack of adequate, large-scale clinical research is primarily because of the legal restrictions scientists face when they study cannabis.
A report by the National Academies of Sciences, Engineering and Medicine examines the many federal regulatory barriers researchers must comply with to research cannabis and its constituents. One issue is marijuana’s classification as a Schedule I drug. Under this classification, marijuana and all Schedule I drugs are defined has having a high potential for abuse and are not accepted for medical use. For example, the Drug Enforcement Agency (DEA) has 90 days to reschedule Epidiolex from Schedule I before it can be prescribed and sold as a pharmaceutical product.
Researchers also face barriers to cannabis supply. Since 1968, the University of Mississippi is the only contractor licensed by the National Institute of Drug Abuse (NIDA) to produce marijuana for federally sanctioned research. This means researchers do not have the option to shop around for different strains and quality of cannabis that may be necessary to address specific research questions.
The DEA changed its policy two years ago, opening its marijuana cultivation contract to other facilities. The DEA has received more than 25 applications since then but has not acted on any of them. Advocates of cannabis research are concerned that the Department of Justice (DOJ) will block the DEA from moving forward on these applications. On April 12, U.S. Senators Orrin Hatch (R-Utah) and Kamala Harris (D-Calif.), released a letter calling on the DEA to cease efforts to delay medical cannabis research.
Until more scientifically rigorous cannabis-related research can be conducted, both the risks and benefits of cannabis and its derivatives will be unclear. This leaves policymakers, medical professionals and patients without a way to make sound, evidence-based decisions on the potential benefits of medical cannabis.
To keep up with the latest marijuana policy and trends, follow NCSL’s Deep Dive Marijuana Page.
Nancy Tran was an NCSL Health and Human Services State-Federal Affairs fellow and an LSU-New Orleans medical candidate 2021.