PROVIDENCE, RI / ACCESSWIRE / June 9, 2020 / https://vimeo.com/715029558
MMJ companies is building a center of marijuana excellence in Rhode Island and has filed for FDA sanctioned clinical trials in Multiple Sclerosis and Huntington’s Disease. MMJ was awarded the much coveted Orphan Designation from the FDA for its planned Huntington’s Disease trials. MMJ has also received a DEA schedule 1 analytical cannabis lab license but the company is still awaiting the final DEA award to cultivate its strain specific marijuana as a pharmaceutical to supply these clinical trials.
The MMJ Companies have recently filed a “WRIT OF MANDAMUS” against the U.S. Drug Enforcement Administration. The DEA has urged a Rhode Island federal judge to dismiss a medical cannabis research lab’s suit accusing the agency of stonewalling its efforts to import and study marijuana, saying the court lacked jurisdiction.
In a reply brief filed on Monday, the DEA said that federal courts of appeal had exclusive authority to hear cases challenging the attorney general’s actions under the Administrative Procedures Act, and any injunction granted by the district court would have unintended ramifications.
“Were the district court able to review such claims, a decision to accept jurisdiction would infringe on the courts of appeals’ future exclusive jurisdiction,” the government wrote in its brief.
The government added that the affiliated companies that brought the action – MMJ International Holdings Corp., MMJ BioPharma Cultivation Inc. and MMJ BioPharma Labs Inc. – could refile their action in the U.S. Court of Appeals for the District of Columbia “or other appropriate geographic courts of appeals,” which have jurisdiction for “exclusive review of DEA’s actions.”
“Permitting another court to review the case not only goes against congressional intent, but interferes with the future jurisdiction of the D.C. Circuit or the First Circuit,” the government wrote.
Duane Boise, president of MMJ, told Law360 on Tuesday that the DEA’s brief was the latest in a long series of delay tactics used by the agency to stymie the companies efforts, and said that he expected the court to rule in the its favor on the jurisdictional issue.
‘Why these people are blocking us is incomprehensible,” he said. “It’s just an egregious dereliction of duty.”
MMJ sued the DEA in April, alleging that the agency had been stonewalling its applications to import and study cannabis for potential uses in treating chronic illnesses for the past three years, even though the planned clinical trials had already been approved by the U.S. Food and Drug Administration.
According to court documents, the DEA allegedly completed its inspection of MMJ’s facilities in October but has not moved on the applications. MMJ said that, in months prior to filing the lawsuit, it had reached out to the agency director, asked its congressman to intervene and called the DEA’s general customer line – all to no avail.
In May, MMJ asked the court for an injunction ordering the DEA to make a final determination on an application to import, study, and develop a cannabis pharmaceutical, saying the agency was in violation of its own rules by holding up the process.
That motion said the DEA has 90 days to make a final determination after the public comment portion of the application process is done; those portions finished in December 2019 and November 2020, and yet the DEA still hasn’t given its final say.
In a motion to dismiss, the DEA opposed the motion for an injunction, arguing that the MMJ companies haven’t stated a claim and are unlikely to succeed on the merits. The DEA had also argued that the companies’ business plan included activities beyond clinical trials, and that they didn’t identify themselves as applying in the narrow field of medical research.
Boise characterized the spat with the DEA as originating with an agency investigator’s misunderstanding, and said the agency had resisted all efforts to resolve the issue before MMJ turned to the courts.
Boise further stated. that” MMJ has developed four years of extreme science and product development, and we expected we were going to get the green light,” he said. “We’re doing this the right way, and they are hassling us. I don’t understand it.”
A spokesperson for the DEA did not immediately respond to a request for comment on Tuesday.
MMJ is represented by Megan E. Sheehan of Sheehan & Associates.
About The Company:
Cannabis Pharmaceutical development is growing and MMJ is changing it for the better. Our mission is to improve the lives of patients. At MMJ we all are united around that common mission – to help people live happier, healthier lives by providing patients better treatment options. We have a commitment to develop DEA, FDA approved cannabis pharmaceutical medicines that best serve patients with unmet medical needs.
MMJ’s world class scientific team is collaborating with others to enhance pharmaceutical solutions across the care continuum.
SOURCE: MMJ International Holdings
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