The purpose for the FDA’s recent publication is public safety.
Last week, the U.S. Food & Drug Administration (FDA) published its current thinking on the research and approval process for cannabis-related drugs. The publication, which among other things recognizes the “increasing interest in the potential utility of cannabis for a variety of medical conditions,” contains critical information for businesses and consumers in the cannabis market—including those wishing to develop new cannabis-related drugs.
For years now, companies have sought to capitalize on widespread consumer interest in cannabis, selling products infused with the psychoactive chemical in cannabis, delta-9 tetrahydracannabinol (THC), or products that are THC-free or low in THC, but are infused with cannabidiol (CBD), which is thought to provide therapeutic benefit. Such products range from “bath bombs” and lotions to gummy bears and tinctures, and are often marketed as therapeutic, with companies touting the ability of THC or CBD to treat a wide range of symptoms and ailments.
But as the FDA, which regulates the marketing and sale of food, drug products, medical devices and cosmetics in the United States, explains in its recent publication, the FDA has approved only one cannabis-derived drug product. Epidiolex (cannabidiol) is FDA-approved to treat seizures associated with two severe forms of epilepsy. In addition, the FDA has approved three synthetic cannabis products: Marinol (dronabinol), Syndros (dronabinol) and Cesamet (nabilone), each of which is approved by the FDA to treat or prevent nausea or vomiting caused by certain cancer treatments.
The purpose for the FDA’s recent publication is public safety. Because of the federal legalization of hemp, which is low in THC but produces CBD, the number of THC- and CBD-infused products being manufactured and sold throughout the U.S. has increased exponentially. To the extent those products are marketed as providing therapeutic benefit, the FDA wants manufacturers and consumers alike to know the difference between a “drug” that has been approved by the FDA as providing a health benefit, and a product a manufacturer claims is therapeutic even though it has not received the imprimatur of the FDA. As the FDA notes, “[c]aregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market.”
Rather than simply warning against the continued marketing of cannabis-related drugs absent FDA approval, the FDA has taken a proactive, helpful approach by explaining precisely how businesses interested in legally developing cannabis drugs can go about doing so, and where interested consumers can learn more about cannabis-related drugs.
For example, the FDA specifically recommends that researchers interested in developing a cannabis-related drug should refer to the Botanical Drug Development: Guidance for Industry and request a Pre-Investigational New Drug application meeting to discuss cannabis-specific issues. In addition, last week’s publication explains that those who are interested in cannabis-related drugs should contact the Center for Drug Evaluation and Research (CDER).
Further, the FDA explains how potential researchers can actually get started on cannabis-related drug research by laying out two pre-study processes for cannabis-related drugs: a five-step process for cannabis study drugs containing hemp (with no more than 0.3% THC) and a seven-step process for cannabis study drugs controlled under the Controlled Substances Act (containing more than 0.3% THC). As the FDA explains, given that the 2018 Farm Bill removed hemp from controls under the CSA, research involving hemp—rather than marijuana—“may result in a more streamlined process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp[.]”
As the market for cannabis (THC, CBD and other cannabinoids) continues to expand, the potential medical benefits of cannabis—both marijuana and hemp and their respective derivatives—remain a primary focus of the industry. Because products routinely enter the marketplace boasting various health benefits, the step taken by the FDA is an important one. The FDA seeks to educate consumers on the realities of cannabis-related drug regulation and to identify a pathway to approval for cannabis-related products, notwithstanding marijuana’s current classification as a federally unlawful controlled substance.
For Further Information
If you have questions about this Alert, please contact Justin M. L. Stern, Frederick R. Ball, Seth A. Goldberg, Jennifer Briggs Fisher, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our or Cannabis Industry Group or the attorney in the firm with whom you are regularly in contact.
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