Cannabis and its derivatives have become a major industry in the U.S. and the U.S. Food and Drug Administration (“FDA”) is coming under increasing pressure to regulate this growing market. As a first step, FDA is on the hunt for data on the safety and efficacy of cannabis and cannabis-derived products. On May 31, 2019 the FDA held a public hearing to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” The problem is that regulatory barriers make it difficult to access raw materials and to perform the research FDA now seeks.
Although under pressure to implement regulatory changes, FDA seeks data to ensure that it is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives before doing so. Acting Commissioner, Dr. Norman (“Ned”) Sharpless, opened the May 31 hearing by referring to some of the legal complexities surrounding cannabis: (i) at the Federal level, marijuana (the drug class parts of the cannabis plant are classified under) is included in Schedule I of the Controlled Substances Act (“CSA”), due to its potential for abuse and the absence of a currently accepted medical use in the U.S.; (ii) the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) removed hemp (cannabis or derivatives of cannabis with a not more than 0.3% THC content by dry weight) from the CSA’s definition of marijuana, so it is no longer a controlled substance under Federal law; and (iii) at the state level, there is a patchwork of laws whereby some states allow for the medical use of marijuana or its derivatives and have decriminalized recreational marijuana possession or allow recreational marijuana use.
Dr. Sharpless gave no indication of any new FDA thinking regarding cannabis-related regulation, but stated that substances derived from cannabis are subject to the same authorities as any other substance marketed as a drug, a cosmetic, a dietary supplement or a food. FDA has only approved a few drug products that contain compounds found in cannabis, most recently EPIDIOLEX (a CBD-containing drug for the treatment of severe seizures in pediatric patients). After the approval of Epidiolex in June 2018, the then-FDA Commissioner, Dr. Scott Gottlieb, released a statement stressing the importance of conducting well-controlled clinical trials to prove the safe and effective medical uses for active chemicals in cannabis and its components.
During the recent hearing, FDA panel members questioned presenters on cannabis and cannabis derivative dosing, different routes of administration, interactions with other drugs, side effects, adverse events, and effects on special populations. A number of speakers expressed a desire to provide the data sought, but explained that the regulatory environment, stemming from cannabis’ Schedule I categorization, means that there is a lack of adequate, large-scale clinical research on cannabis and its derivatives.
To illustrate, one important barrier encountered by scientists is that the cannabis supply to researchers is restricted. For decades, the University of Mississippi has been the sole contractor licensed to produce marijuana for federally sanctioned research. As such, researchers only have access to certain strains and quality of cannabis, which are not necessarily representative of those available to the public. In August 2016, the U.S. Drug Enforcement Agency (“DEA”) adopted a new policy designed to increase the number of entities registered under the CSA to grow marijuana to supply legitimate researchers in the U.S. The DEA has received more than 25 applications, but no new contractors have been approved.
Additionally, in order to conduct trials on marijuana or its derivatives, researchers must obtain a number of approvals from federal, state, and/or local institutions. Such approvals, designed to prevent the acquisition of controlled substances for non-research purposes, include: (i) investigator registration and site licensure from DEA; (ii) a letter of authorization from the National Institute on Drug Abuse, in order to obtain research-grade cannabis from an approved source (University of Mississippi, for now); (iii) submission of a research protocol to the DEA detailing security provisions for storing and dispensing controlled substances; and (iv) in some states, controlled substance certification or registration from a state board of medical examiners or a department of the state government.
On June 19, Dr. Amy Abernethy (FDA’s Principal Deputy Commissioner) and Lowell Shiller (FDA’s Associate Commissioner for Policy), co-chairs of FDA’s CBD working group, released a statement titled “FDA is Committed to Sound, Science-based Policy on CBD“. This statement expressly acknowledged concerns aired at the May 31 hearing about the challenges in conducting research with cannabis and CBD, but did not offer any indication of how these issues may be resolved. FDA did however take the opportunity to remind readers to submit comments to the public hearing docket (docket number FDA-2019-N-1482). If you have any observations or data that you would like to contribute to FDA, the deadline for submission is July 16, 2019 (extended from July 2).