SPX3,845.08+13.69 0.36%
DIA310.41+0.70 0.23%
IXIC11,361.85+39.61 0.35%

DEA Stonewalling MMJ's MS & Huntington's Disease Clinical Trials For 3 Years

MMJ companies are 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 drug designation from the FDA for its plann...

Benzinga · 06/10/2022 09:18

MMJ companies are 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 drug designation from the FDA for its planned Huntington's disease trials, and 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.
"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."
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.
Duane Boise, president of MMJ 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 "MMJ has developed four years of extreme science and product development, and we expected we were going to get the green light. We're doing this the right way, and they are hassling us. I don't understand it."

Photo by Sasun Bughdaryan on Unsplash

Related News

DEA Delays Medical Marijuana Clinical Trials Yet Illicit Market Continues To Thrive

'DEA Has Blown It Again' - MMJ Request Federal Court Action For Emergency Motion To Expedite

MMJ BioPharma Cultivation To Produce Quality Cannabis, Meeting DEA's Definition Of Chemical Reproducibility