The FDA's report calls for additional research, including extensive use of real-world data (RWD)—data relating to patient health status and health care delivery to understand potential adverse reactions to CBD better. This information, the agency says, is necessary to approve its use to treat various ailments.
"While the FDA appreciates the information and engagement from numerous stakeholders on CBD-related issues, many evidence gaps remain," the report's authors, FDA Commissioner Stephen M. Hahn and Principal Deputy Commissioner Amy Abernethy said.
"Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods," According to the report. These methods would include "better sources of RWD to provide incremental improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations."
Hahn and Abernethy add that the agency is planning to engage with various stakeholder groups to obtain the RWD necessary to understand any safety risks better. "We strongly believe that RWD, when collected and analyzed using rigorous methods, can be important for moving the science forward—including by aiding hypothesis generation and by refining the design of follow-up studies," they said.
The FDA will also be partnering with other government agencies, industry stakeholders, and members of academia to develop the foundation for CBD data collection and analysis projects. Hahn and Abernethy added that these efforts would build upon existing independent state and national quality and safety monitoring efforts, observational study data models, and novel data sources.
Simultaneously, there is a need for more than just RWD research as such observational data would be insufficient to address specific toxicological issues, they said. Using animal studies would be necessary to determine chronic, developmental, and reproductive toxicity resulting from CBD use, Hahn and Abernethy noted in the report.
The FDA is planning to apply a series of guiding principles for this work, including:
- Research projects should develop a more sophisticated data infrastructure for understanding the safety and quality of CBD products.
- These projects should yield information that helps refine future studies.
- Research projects should be designed to complement existing work by other public health agencies, such as NIH and SAMHSA, and other stakeholders, including poison control centers and emergency departments.
Potential Challenges Ahead
Regardless of the guiding principles used, the type of research undertaken, or the partners identified by the FDA, the agency sees several challenges to obtaining the safety data it needs.
First, as the report describes, the FDA needs more systematic data collection and analysis of safety risks, something more active than the prevalent method of collecting adverse events as they arise from places such as poison control centers. Researchers also need to understand better CBD use rates, including rates of use for specific CBD products. For example, what populations have the highest CBD exposure, and what products are most frequently used?
There is also a need for “longitudinal studies” that consider subjects' health over an extended period to understand CBD use's long-term health effects better. There is also a lack of specific codes to precisely identify CBD products that could hinder data collection.
Hahn and Abernethy conclude by noting that the agency, in the coming months, will develop and refine its plans for research projects to obtain additional safety data. These research projects will use a variety of strategies to get this data, including:
- Working with existing and emerging data systems enables precise identification of CBD products that may be associated with reported adverse events.
- Evaluate approaches to link adverse event data with CBD product sampling and testing data.
- Collaborate on developing and evaluating systems and methods to understand safety outcomes better and incorporate data from other sources.
- Evaluate the use of market research data and other data sources that provide insights on the use of specific CBD products in different populations.
- Evaluate the use of data linkage approaches to provide insights about safety risks that may appear across time while protecting patients' and consumers' privacy.
- Evaluate the value of combining multiple research and data approaches to synthesize an aggregate view of CBD safety and quality across the market and across time.
- Evaluate which strategies are best for safety and quality monitoring for different types of CBD products.