FDA Issues Draft Guidance on Clinical Research with Cannabis and Cannabis-Derived Compounds

FDA, Medical Cannabis, Medicare Set-Aside Blog on July 28, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

Medical cannabis continues to create a host of questions as related to workers’ compensation claims, including the legality of use, particularly as guidance and policies continue to be issued.  On July 21st, the FDA issued draft guidance for clinical research with cannabis and cannabis-derived compounds. The guidance does not apply to fully synthetic versions of cannabis, which are regulated in the same manner as other synthetic, non-cannabis containing compounds.

The need for guidance on this topic was triggered by a recent change in Federal law. Since its enactment in 1970, the Controlled Substance Act (CSA) has designated marijuana as a Schedule I controlled substance. As a reminder, Schedule I controlled substances do not have any accepted medical uses and carry a high potential for abuse and misuse. Historically, the exclusive source of cannabis for use in clinical research was the Drug Supply Program (DSP), which is made available through the National Institute on Drug Abuse (NIDA). In 2018, the Farm Bill (the Agriculture Improvement Act of 2018) bifurcated marijuana into two categories, marijuana and hemp. By definition, hemp is cannabis, a cannabis derivative or a cannabis extract that contains less than 0.3% by dry weight of the compound delta-9 tetrahydrocannabinol (THC). Since THC is the component of marijuana that is largely responsible for its psychoactive effects, cannabis compounds that contain a minimum amount of THC do not have the abuse potential of those compounds with higher amounts of THC. The Farm Bill removes hemp from the definition of marijuana which means that hemp is no longer a controlled substance under the CSA. Clinical researchers using hemp are not required to use the DSP as the source of cannabis for a study or clinical trial. As a result of this change, the FDA has begun to see non-DSP sources of hemp submitted as part of clinical trial data as well as variations in the methods utilized by researchers to validate drug sources.

As clinical research to support drug development progresses from phase I to phase 2 and phase 3, the FDA requires information to validate the identity, quality, purity and potency of the drug under development. The information required for cannabis and cannabis-derived products is the same as that required for non-cannabis compounds, and can be found in already-existing FDA publications. The draft guidance reinforces the availability of this information for clinical researchers using cannabis. The FDA also encourages drug developers to calculate the level of delta-9 THC in the drug product early in the development process, to avoid the misclassification of hemp as marijuana or vice versa. The draft guidance contains a list of several reference documents which can be used to properly evaluate the level of delta-9 THC within a drug compound. The method used to quantify the level of delta-9 THC within a compound may differ slightly depending on whether it is a solid or a solution.

You can access the full-text draft guidance here. Comments regarding the draft guidance are due to CMS by September 21, 2020. As regulatory guidance continues to evolve in this area, we’ll continue to post updates here, and advise of any potential impact to claims.