On Tuesday morning, the US Food and Drug Administration released draft guidance that reflects the Administration’s “current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.”
This guidance does not “establish legally enforceable responsibilities,” but instead “should be viewed only as recommendations.” Public comment is open for 60 days.
The draft is focused on drugs for human consumption, and covers “botanical raw materials, extracts, and highly purified substances of botanical origin.” Only one such drug is approved by the FDA, and only since 2018: Epidiolex, the CBD-based cannabis extract for patients with serious seizure disorders. (Synthetic products, such as the THC-based Marinol, have been on the market for decades, and patients have long complained about their efficacy and side effects, compared to whole plant products.)
While it is often accurately noted that the 2018 Farm Bill legalized hemp, it is more specifically accurate to say that it legalized cannabis plants with .3% THC or less, and it also legalized all other cannabinoids found within the plant. The question of what to do next with these cannabis plants and derived products has fallen out of the purview of the US Drug Enforcement Administration and into the laps of the US Department of Agriculture and the FDA, respectively.
(Read Cannabis Wire’s coverage of FDA’s ongoing rulemaking deliberations for over-the-counter and retail CBD products, following the passage of the 2018 Farm Bill.)
The research recommendations in the draft guidance include:
Cannabis supply: Until the 2018 Farm Bill, only cannabis grown at the University of Mississippi as part of the National Institute on Drug Abuse’s Drug Supply Program could be used for clinical research. Now, the FDA notes, hemp can “serve as a source of cannabis and cannabis-derived compounds for drug development.” Considering that hemp cultivation licenses are widely available and for decades only one federal cultivation license has been made available for cannabis research, this promises to swing the door open to research and development on cannabis plants and cannabinoids through hemp. (As Cannabis Wire has reported, the DEA has opened an application process to consider additional federally-licensed cannabis cultivators for research, but it has been slowed by a number of delays.)
Quality control: When it comes to quality control, the FDA notes that those putting forth products for clinical research must show they can “consistently manufacture a quality product.” The FDA points toward guidance for botanical drug development, but also notes some cannabis-specific recommendations. For example, they note that “adequate characterization of cannabis and cannabis-derived compounds, for example via a chemical fingerprint, is critical to ensuring batch-to-batch consistency.”
The FDA is also seeking quantitative data beyond cannabinoids, and is suggesting that sponsors share data on “phytochemicals that are present in their proposed product, including but not limited to, cannabinoids, terpenes, and flavonoids.”
Calculating THC: It will be necessary to prove that a product contains .3% THC or less in order to fall under these research guidelines. The FDA says that those hoping to conduct research will need to provide “quantitative data, such as a certificate of analysis from a laboratory described in the USDA interim final rule, indicating the percent delta-9 THC by dry weight in their botanical raw material.” They will also need to provide “detailed descriptions of testing methods used to evaluate the level of delta-9 THC for phase 2 and phase 3 studies and marketing applications.”
