FDA Guidance on Clinical Trials with Cannabis: Same Info, Repackaged?
(Thursday, January 26, 2023)
This week’s FDA guidance on the conduct of clinical trials involving cannabis and its derivatives reminds the developers of two critical aspects of the regulation of such products by the FDA and confirms the associated regulatory processes. First, cannabis products containing greater that 0.3 percent delta-9 tetrahydrocannabinol (THC) are still federally regulated as controlled substances regulated by the Drug Enforcement Administration (DEA), and second, that such products are considered botanical drug products (BDP) when disease-specific therapeutic or preventive claims are made which are regulated by the FDA. The guidance states the obvious based on the above two aspects. Developers of cannabis products are instructed to contact the DEA to comply with the applicable DEA requirements for Schedule I cannabis-derived material. And the developers are instructed to contact the FDA and conduct development under IND applications, like other botanical drug products. This includes conducting well-controlled clinical trials using standardized cannabis-derived investigational products (CDIP). The investigational products musts be manufactured in compliance with pharmaceutical good manufacturing practices (cGMP) to ensure that the products are of consistent quality and purity. The same requirements as those for BDPs for contaminants, such as pesticides and heavy metals, as well as verifying the accuracy of the labeling and packaging, are applicable to CDIPs as well. FDA refers the developers to its previous guidance for BDPs for detailed instructions for CDIPs. For the design of clinical trials and regulatory requirements, these products will be treated the same way as any new BDPs. With the legalization of cannabis at several states, cannabis products containing higher than 0.3% THC are widely available. Acknowledging that, FDA allows sourcing of the CDIPs from any available vendor so long as they meet the GMP requirements for IND products. FDA requires that the sources of the CDIPs be DEA-authorized growers. The guidance does not present any surprises but should clarify and confirm the widely held opinions regarding the Federal regulatory requirements for CDIPs.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC