A medical cannabis research lab has filed a new federal lawsuit accusing the U.S. Drug Enforcement Administration of stonewalling its applications to import and study cannabis for potential uses in treating chronic illnesses for the past three years.
In a complaint filed Friday in Rhode Island federal court, affiliated companies MMJ International Holdings Corp. and MMJ BioPharma Cultivation Inc. said the DEA had delayed the process, tying the companies' hands, and recently have refused to give an update despite multiple prods.
"Countless patients who have been affected by multiple sclerosis and Huntington's disease and are waiting on the potentially life-restoring treatments associated with the development of these pharmaceuticals," the companies wrote in their complaint.
The companies claim they first petitioned the DEA in December 2018 for the green light to import the specific strains of marijuana needed to conduct MMJ's planned clinical trials, which had already been approved by the U.S. Food and Drug Administration.
"MMJ's research and development requires painstakingly careful control of all plant genetics in order to maintain compliance with FDA requirements regarding the consistent reproducibility of the compounds found in the pharmaceutical," the company said.
What allegedly followed was a yearslong slog whereby MMJ attempted to secure approvals from DEA to import research marijuana and manufacture its formula. The agency allegedly completed its inspection of MMJ's facilities in October but has not moved on the applications.
The company claims that in recent months it reached out to the agency director, asked its congressman to intervene and called the DEA's general customer line — all to no avail.
"Despite numerous attempts to follow up and check the status of the registration approval determinations for manufacturing and importing, DEA personnel have expressed to MMJ Cultivation that they have not yet made final determinations and they have no idea when that determination will be made," the complaint said.
Marijuana's Schedule I status has been a significant obstacle to performing the research that both advocates and opponents of legalization say is required. The University of Mississippi's National Center for Natural Products Research has been the sole grower of research marijuana approved by the DEA since the early 1970s. The agency only began receiving applications for new growers in the last few years.
Legislation pending in Congress would allow scientists to perform studies on cannabis sold in regulated stores in states where it is legal, but critics say it does not do enough to fund or incentivize new cannabis research.
The company is seeking a declaration that the DEA violated the Controlled Substances Act and Administrative Procedure Act and an order requiring the agency to move on the applications within seven days.
Counsel for MMJ did not immediately respond to a request for comment Wednesday. A spokesperson for the DEA declined to comment on pending litigation.
MMJ is represented by Megan E. Sheehan of Sheehan & Associates Law.
Counsel information for the DEA and other government parties was not immediately available Wednesday.
The case is MMJ International Holdings Corp. et al. v. Merrick Garland et al., case number 1:22-cv-00152, in the U.S. District Court for the District of Rhode Island.
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