In 2016, the Drug Enforcement Administration (DEA) announced that it would be adopting a new policy designed to increase the number of entities that could manufacture marijuana for the use in federally approved research. However, despite receiving at least two dozen applications to grow research marijuana since that announcement, to date the University of Mississippi still holds the only license to manufacture marijuana for research in the United States. Although, that may finally be about to change.
Last month, the Scottsdale Research Institute, LLC (SRI) filed a petition for a writ of mandamus in the U.S. Court of Appeals for the District of Columbia Circuit against the DEA. The petition sought to force the DEA to respond to SRI’s application to manufacture marijuana for research purposes, which SRI filed in 2016. The petition further asserts that the DEA has failed to comply with certain statutory deadlines regarding clinical research-based manufacture applications, causing an unreasonable delay in the processing of SRI’s application. SRI argues that the “DEA’s delay in noticing or responding to SRI’s application is unlawful, unreasonable, and egregious. It contravenes the letter and spirit of the [Controlled Substances Act], seriously harms SRI, and hampers SRI’s efforts to help suffering veterans through clinical research.”
This week, in what could be classified as a procedural win for SRI, the court ordered the DEA to file a response to SRI’s petition within 30 days. The court order will come as good news to the multiple other research-grade marijuana manufacturers that have submitted applications. In its petition, SRI outlines multiple attempts by SRI, congressional representatives, and senators to obtain status updates on the marijuana research applications from the attorney general and the DEA only to receive no coherent response. With this recent order, there is now some hope that the DEA will have to articulate some rational response for the delay in processing the applications. Ultimately, this lawsuit will not result in the grant or denial of SRI’s application, as that authority still remains with the DEA, but it may prompt the DEA to take some action on SRI’s application and the twenty-some others it has received.
With government regulations and action seemingly lagging behind public opinion and progress in the cannabis sector, SRI’s lawsuit could prompt similar litigation against federal and/or state agencies to stay up to speed in their dealings with the cannabis industry. For example, depending on the outcome of SRI’s lawsuit, this may open the door to lawsuits from other research-grade manufacture applicants in order to push their applications along. Notably, the DEA is also currently facing a separate lawsuit filed by a coalition of patients and advocates regarding the DEA’s delay in addressing marijuana’s schedule I status. It is also foreseeable that similar litigation could impact the FDA’s approval of marking applications for CBD for the treatment of disease and/or CBD derived drug products. As always, we will continue to monitor this case and its potential influence on future litigation.