A company focused on developing marijuana-derived pharmaceuticals is suing the Drug Enforcement Administration (DEA) over what it calls “exponential delays” in the agency’s process for granting licenses to grow cannabis for medical research.
Rhode Island-based MMJ BioPharma Cultivation Inc. filed a petition for a writ of mandamus in the U.S. Court of Appeals for the D.C. Circuit on Friday, alleging that DEA’s yearslong licensing application process has hamstrung the company’s business and stymied innovation that could benefit patients. It’s asking the federal court to compel the agency to act.
“Despite beginning this process in November of 2017,” the company says in the lawsuit, “MMJ has been unable to conduct the research that it was created to do.”
MMJ is working to produce a gel capsule containing cannabis extracts, which it says is intended to treat multiple sclerosis and Huntington’s disease. While it previously received DEA authorization to import marijuana into the U.S. from Canada, MMJ later applied for permission to cultivate cannabis in-house for research and development purposes.
“This registration is essential to MMJ’s ability to conduct FDA-sanctioned clinical trials,” the company says, “because without the ability to cultivate their own marijuana, they are unable to produce the proper compound.”
MMJ asserts that DEA’s pre-registration investigation for the license application began in June 2021 and lasted through the following October. “At the end of the visit, the diversion investigator informed MMJ that they would return to the DEA office, ‘write up’ the report, and submit the report to their group supervisor who would then submit those findings to DEA Headquarters for a final determination,” the suit says.
But according to the petition, no final determination ever came. “Despite numerous attempts to follow-up and check the status of the registration approval determinations for manufacturing, DEA personnel have expressed to MMJ that they have not yet made final determinations and they have no idea when that determination will be made,” it says.
Hellbound and Down 