Megan Sheehan of Sheehan & Associates, Attorneys representing MMJ International Holdings and MMJ BioPharma Cultivation etal, scheduled to execute on clinical trials in Huntington's disease and multiple sclerosis, filed a motion in federal court against the Drug Enforcement Administration, asking the federal court for "an emergency motion for irreparable damages".
This motion will hopefully induce the DEA to respond promptly to MMJ's application to manufacture marijuana for research purposes according to the DEA's self mandated timeline.
The attorneys will argue that "the DEA has blown it again " stated CEO Dr. Elio Mariani citing that the Drug Enforcement Agency is taking too long to issue a determination for its application for cultivation and research.
The plain language of the Controlled Substances Act states that for applications for clinical trials:
"…the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 824(c) of this title, unless the Attorney General has granted a hearing on the application under section 958(i) of this title." Emphasis added, 21 US Code § 823(i)(2).
Tim Moynahan, attorney and chairman stated " MMJ has consistently responded to every request, and we have gone above and beyond to demonstrate compliance. MMJ is looking for a final determination from the court in accordance with the DEA's own statutes and regulations.
Duane Boise president and founder stated "MMJ was not looking to get into a lawsuit but we have had exhausted all means to resolve the issue amicably, including multiple calls to the DEA, Congressional inquiries, and letters to the DEA administrators which have all gone unanswered".
The company is further requesting "declaratory and injunctive relief" as a result of the DEA's violation of the Administrative Procedures Act for the DEA's "unreasonable delay in determining the outcome of its applications for registration for marihuana manufacturing and importing for its pending FDA sanctioned clinical trials."
The initial "writ of mandamus lawsuit" was filed in the U.S. Federal Court for the District of Rhode Island Circuit on April 8, 2022.
"The DEA's delay in noticing or responding to MMJ's application is unlawful, unreasonable, and egregious," MMJ wrote in a summary of its argument. "It contravenes the letter and spirit of the CSA, seriously harms MMJ, and hampers MMJ's efforts to help patients suffering from MS and Huntington's disease through clinical research."
"Everyone-including the agency-agrees that this research is important and that the need for research generally is urgent," they wrote. "Here, the DEA can act with little expenditure of resources but has failed to do so."
