Federal officials are preparing for a ramp up in cannabis-related research.
On Wednesday, researchers from the U.S. Food and Drug Administration published an article that provides an overview of cannabis research applications the agency has received over the past half century, and that looks to the future of this booming area of research. The article, titled From Our Perspective: FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development, is published in a special issue of the journal Exploration in Medicine titled Beyond Weed: Clinical Applications of Cannabis and Cannabinoids.
The overview from researchers at the Center for Drug Evaluation and Research, within the FDA, comes on the heels of the agency’s recommendation that cannabis be moved from Schedule I, a category for substances with no medical use and high misuse potential, where it has been for more than fifty years, to Schedule III. Last October, President Joe Biden called on the U.S. Department of Health and Human Services and the U.S. Attorney General to review how the federal government classifies cannabis. If the Drug Enforcement Administration agrees with the FDA’s recommendation, it would be the first change in how the federal government classifies cannabis since the passage of the Controlled Substances Act of 1970.
The article authors, Cassandra Taylor and Schuyler Pruyn, provided a summary of the hurdles they hit as reviewers of cannabis-related Investigational New Drug applications, which are submitted to the FDA by entities hoping to conduct research on humans. The challenges that the authors highlighted include “inadequate quality and manufacturing information,” “unknown safety profiles and unknown benefits/risks for emerging compounds,” and the “complex matrix effects on testing of final product formulations.”
They wrote that the FDA has received more than 800 cannabis-related IND applications submitted by academic researchers or “commercial developers” since the early 70s, They provided a breakdown of application types received to-date into four buckets: (53%) pain medicine and addiction, (19%) neurology, (14%) immunology and inflammation, and (9%) psychiatry.
Further, the authors note that cannabis product types under study have become more diverse over time, and in particular since the 2010s.
“The product types studied have expanded greatly in recent years and include a wide variety of topical, inhalable, injectable, and oral products,” the authors wrote.
The increase in the diversity of routes of administration “correlates” with the FDA approvals of Syndros in 2016 and Epidiolex in 2018, the authors wrote. Epidiolex, a CBD-based drug, was the first FDA-approved pharmaceutical containing a cannabis plant extract. The diversity also coincided with “increased availability of products in the state-level marketplace, along with the passage of the Agricultural Improvement Act (i.e., the Farm Bill).” The 2018 Farm Bill legalized hemp, defined as a cannabis plant with .3% THC or less, and, perhaps inadvertently, depending on who you ask, catalyzed the hemp-derived CBD industry.
As demand for hemp-derived CBD products soared, pressure mounted on the FDA to issue regulations and provide a legal pathway for these products for which no federal regulations currently exist. In January, the FDA announced that the existing pathways available to it, such as food or supplements, are “not appropriate” for CBD. It called on Congress to help create a new pathway for these products.
Still, the FDA has become increasingly active on cannabis and cannabinoids, often emphasizing the need for “more data.” In October 2021, the FDA announced the creation of 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.” In January, the FDA also issued guidelines for researchers, titled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.
In the article published this week, the authors also gave their thoughts on the “future of cannabis drug development,” which includes their prediction of a continued uptick in cannabis-related applications.
“As more medical and adult-use (i.e., non-medical) programs at the state-level evolve, there will likely be increased interest in clinical research to study [cannabis and cannabis-derived products] that are commonly used by consumers in state-level programs. With this, it is also expected that FDA will see new, innovative products for evaluation under INDs submitted to the Agency,” the authors concluded. Those products might include rarer cannabinoids or terpenes, for example, or edibles or “novel delivery systems.”
Finally, the authors reiterated the Administration’s previously stated stance that it believes that the drug development pathway is the “best way to ensure that safe and effective new medicines are available to patients in need of appropriate medical therapy” for drugs including cannabis or cannabinoids.
“The FDA will continue to encourage robust clinical research” of cannabis and cannabis-derived products, and “supports sound, scientifically based research into the therapeutic uses of [cannabis and cannabis-derived products] and will continue to work with companies interested in bringing safe, effective, and quality drug products to market,” the authors concluded.
