A medical marijuana company that focuses on developing cannabis-derived pharmaceuticals has filed a suit against the U.S. Drug Enforcement Administration (DEA) over “exponential delays” in the agency’s licensing process for cultivating medical research cannabis. MMJ BioPharma Cultivation sued the DEA in the U.S. Court of Appeals for the DC Circuit, claiming that the DEA’s licensing process, which can take several years, has prevented innovation which could help patients and which hamper the company’s business.
The Rhode Island-based medical cannabis company asked the federal court to compel the DEA into action and hopefully streamline its licensing process. MMJ said in its suit that although it began the licensing process in late 2017, several years of licensing delays have kept it from carrying out the research it was meant to do. The company is currently working to develop gel capsules with marijuana extracts to treat Huntington’s disease and multiple sclerosis (MS).
The DEA allowed MMJ to import cannabis for research from Canada, but the medical cannabis company ran into a wall when it applied for a license to cultivate cannabis for research purposes in-house rather than obtain it from Canada. According to MMJ, granting the company in-house cultivation privileges is “essential” to its ability to run clinical trials on the efficacy of cannabis against various health conditions.
MMJ added that without the ability to grow cannabis in-house to its own specifications, the company cannot develop a proper compound.
Its petition notes that it began the preregistration process for license application in June 2021 and went through several steps before a DEA diversion investigator informed MMJ officials they needed to wait for a final determination from DEA Headquarters. The petition claims MMJ did not receive a final determination from the DEA despite numerous follow-up attempts.
Furthermore, DEA personnel told MMJ officials that the agency still hadn’t made the final determination and they had “no idea” when the DEA would make the determination. According to the court filing, DEA personnel responded to subsequent inquiries on the progress of the final determination with statements such as, “Why do you want to know?” and “We’ll get to it when we get to it.”
MMJ states that the DEA still hasn’t made a final determination on its in-house cannabis cultivation license for research purposes for “some inexplicable reason,” even though the agency granted it a research license.
Company president Duane Boise argued in a press release that the DEA had failed its legislative mandate and pledged to get to the bottom of the issue.
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