The Marihuana and Cannabidiol Research Expansion Act would promote the development of research addressing the potential medical applications of marijuana and cannabidiol (CBD) by reducing regulatory barriers to conducting research. Specifically, the bill aims to create efficiencies in regulatory pathways to research approval and broaden opportunities to cultivate and manufacture marijuana derivatives for research purposes.
The bill would accelerate the process of registering research protocols involving marijuana and CBD with the Drug Enforcement Agency (DEA) by setting strict timelines for the review of applications submitted through the current registration system. To expedite the submission of revisions in the case of a subsequent denial, the bill would also amend section 303 of the Controlled Substances Act (21 U.S.C. 823(f)) to create a new pathway for introducing supplemental information or amendments into pre-existing applications to register.
The National Institute on Drug Abuse, under the authority of the DEA, currently holds the majority of marijuana and CBD supplies for research. To improve access to research-grade strains, the bill would enable research groups and pharmaceutical drug developers to cultivate their own batches of marijuana, while reinforcing security measures in research and manufacturing facilities. As such, the bill seeks to enable the development of medicines containing marijuana and CBD that would be eligible for Food and Drug Administration approval.
The bill would finally commission the Department of Health and Human Services, National Institutes of Health, and other responsible federal agencies to produce a report with recommendations to assess current evidence on the medical risks and benefits of marijuana; persistent policy barriers to conducting research, especially in states where marijuana is legal; and ways to verify the potency and purity of marijuana-derived products within the current regulatory framework.
The introduction of the bill was followed by an announcement from the DEA promising better access to marijuana in scientific and medical research. Yet an analysis by STAT News shows that similar promises from the DEA to “increase the lawful supply of marijuana available to researchers” made in 2016 still remain unfulfilled as of September 2019.