A company focused on developing marijuana-derived pharmaceuticals is suing the Drug Enforcement Administration (DEA) over what it calls “exponential delays” in the agency’s process for granting licenses to grow cannabis for medical research.
Rhode Island-based MMJ BioPharma Cultivation Inc. filed a petition for a writ of mandamus in the U.S. Court of Appeals for the D.C. Circuit on Friday, alleging that DEA’s yearslong licensing application process has hamstrung the company’s business and stymied innovation that could benefit patients. It’s asking the federal court to compel the agency to act.
“Despite beginning this process in November of 2017,” the company says in the lawsuit, “MMJ has been unable to conduct the research that it was created to do.”
MMJ is working to produce a gel capsule containing cannabis extracts, which it says is intended to treat multiple sclerosis and Huntington’s disease. While it previously received DEA authorization to import marijuana into the U.S. from Canada, MMJ later applied for permission to cultivate cannabis in-house for research and development purposes.
“This registration is essential to MMJ’s ability to conduct FDA-sanctioned clinical trials,” the company says, “because without the ability to cultivate their own marijuana, they are unable to produce the proper compound.”
MMJ asserts that DEA’s pre-registration investigation for the license application began in June 2021 and lasted through the following October. “At the end of the visit, the diversion investigator informed MMJ that they would return to the DEA office, ‘write up’ the report, and submit the report to their group supervisor who would then submit those findings to DEA Headquarters for a final determination,” the suit says.
But according to the petition, no final determination ever came. “Despite numerous attempts to follow-up and check the status of the registration approval determinations for manufacturing, DEA personnel have expressed to MMJ that they have not yet made final determinations and they have no idea when that determination will be made,” it says.
When the company inquired about the status of the registration nearly six months later, in April 2022, “DEA personnel responded, ‘why do you want to know?’” the filing alleges, “and recently in June 2023, they said that ‘they’ll get to it when they get to it.’”
While DEA has found MMJ’s security and diversion plans “sufficient for researcher registration,” the company adds, the agency “has been unable to make a determination for MMJ Cultivation’s manufacturing registration for some inexplicable reason which has not been articulated to MMJ.”
Lawyers for MMJ argue that DEA has failed to meet its obligations under federal law, including cannabis research legislation, the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), that President Joe Biden signed into law late last year in order to expedite the licensing process.
In relevant part, the lawsuit says, the research bill “mandated DEA application responses within a 60-day period,” a window that, in MMJ’s case, has long passed. “DEA has flagrantly ignored the deadlines put in place by the CSA and the MCREA, as well as ignored the requests of the sitting President of the United States,” the suit says.
“The issue is why has the DEA failed its legislative mandate?” MMJ President Duane Boise said in a press release prior to filing the suit. Company CEO Elio Mariani pledged “to get to the bottom of this at all cost.”
Barrington, Rhode Island-based attorney Megan Sheehan is representing the company in the matter.
In November 2022, a federal judge in Rhode Island dismissed the company’s civil suit against the government for lack of subject matter jurisdiction.
MMJ isn’t alone in its frustration over the federal government’s protracted cannabis bureaucracy. For years, bipartisan congressional lawmakers have bemoaned DEA’s delays, especially for its failure to license more cultivation for research purposes.
In 2019, Rep. Buddy Carter (R-GA), slammed DEA as the “epitome of ineptitude,” saying the agency was “failing the American public” by failing to reschedule cannabis.
A year later, 11 bipartisan members of Congress sent a letter saying that DEA’s sluggishness was costing America jobs.
That helped lead to the passage of the 2022 medical marijuana research bill, which aimed to speed the process. And in recent years, several more research growers have obtained licenses. Today DEA lists eight “bulk approved marihuana growers” on its website, though critics say production is still severely limited.
Even DEA has recognized some delays in the government’s handling of marijuana matters. Last month, DEA Administrator Anne Milgram committed to asking the Department of Health and Human Services (HHS) for a timeline on the ongoing review of marijuana’s federal scheduling status.
Milgram said that DEA has not yet received a scheduling recommendation from HHS, which is carrying out a scientific review into marijuana. When the agency does receive it, it will then carry out its own eight-factor analysis and open public comment before making the final call.
The administrator also told told Rep. Matt Gaetz (R-FL) that the president “had sent a letter to the secretary of HHS and to the attorney general to ask for the scheduling—descheduling process to begin.” But earlier this month, HHS said it had no record of that document.
Read MMJ’s full filing with the DC Circuit below:
Photo courtesy of Chris Wallis // Side Pocket Images.