Much of the information coming out of the U.S. Food and Drug Administration about CBD in recent months and years has been, basically: we need more info.
The FDA is charged with creating the regulations for cannabidiol (CBD) and other cannabinoids from cannabis after the 2018 Farm Bill legalized hemp, defined as cannabis plants containing .3% THC or less. The agency is making strides on collecting that data. They’ve announced “accelerated” collection proposals, for example, and plans for partnerships. Still, whenever someone from the FDA speaks these days, it seems like the cannabis industry pays particularly close attention, perhaps looking for tea leaves to read.
Two weeks ago, the Council for Federal Cannabis Regulation (CFCR) hosted a webinar called “The Endocannabinoid System: Implications for Research and Regulatory Science” that included Cassandra Taylor, a chemist at the FDA within the Center for Drug Evaluation and Research (CDER), and Dan Mellon, the FDA’s Deputy Director for the Division of Pharmacology Toxicology for Neuroscience, among others. CFCR is a newly-formed national group focused on federal cannabis regulations.
For people who are new to the FDA’s many pathways to product approval, Taylor recommended a “pre-IND” (investigative new drug) meeting with someone from the agency to drill down on specifics. One repeated point was that each FDA applicant is unique. So while the two FDA speakers gave birds’ eye insights on the process, they often encouraged attendees to first peruse existing resources on the FDA’s site.
For example, if a cannabis product required a smoking device, an applicant would have to look at the FDA’s Center for Devices. Generally, the device itself would become part of the overall application.
“A lot of these devices may have heating elements. They may have various materials that are part of the container closure system. All of that is part of the evaluation that is done for any drug product and would be done as well for botanical products,” Mellon said.
Mellon spoke about how any botanical product, cannabis or otherwise, is the sum of its parts. Or, as Mellon put it, a “mixture” of all of the compounds within the plant, which are different from isolated compounds, like THC or CBD alone. This plays into botanical drug development, because “a mixture may also have a very different safety profile.”
“One of the biggest challenges is trying to really bridge the knowledge that we have on those particular compounds in that particular mixture, from one product to another, or trying to leverage data that perhaps may not have been generated with that particular compound,” Mellon said. “I think it’s very important to think about those things as anybody starts trying to think about how they might try to develop products of this nature.”
Another topic that came up several times during the webinar was “real world data.” Those words have been a focus for the FDA because the agency wants more specifically on the highly-popular-but-federally-unregulated cannabidiol, or CBD. (CBD can be derived from hemp, and hemp is now federally legal.)
“We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding,” former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy wrote in a “Voices on Policy” update last year. They emphasized that real-world data “may identify new potential adverse events or subpopulations of CBD users that should be the focus of follow-up studies.”
One example of the type of data that the FDA isn’t looking for: 10,000 people have used our CBD product “and nobody’s had a problem,” Taylor said.
That won’t come close to cutting it for the FDA.
“That’s very different than a careful analysis of say, blood draws monthly, to look for specific changes in liver enzymes or in kidney function or something else, or how fast these products are metabolized or excreted,” Taylor said. “Those are very important components that go into the assessment, and what I would call creating real world evidence, as opposed to just capturing data.”
The Administration has been persistent about this need. Last October, the FDA released the “Cannabis-Derived Products Data Acceleration Plan” because the growth of the U.S. cannabis product market “continues to outpace the growth in the science and our understanding of the public health implications of these products.”
During the webinar, Taylor emphasized the importance of clinical trials when it comes to data collection, too. Without those, it’s “very hard for us to get an understanding of what those safety concerns could be.”
