A company that specializes in developing marijuana-derived drugs is suing the Drug Enforcement Administration over what they call “exponential” delays in the process of granting licenses for growing cannabis for medical research.
MMJ BioPharma Cultivation Inc., a Rhode Island-based company, filed a petition to the U.S. Court of Appeals in Washington D.C. for a writ of Mandamus. Circuit, claiming that the DEA’s lengthy licensing process has hampered their business and stymied innovations that could benefit patients. The company is asking the federal court for an order to force the DEA to take action.
The company claims that “despite beginning this process in Nov. 2017,” it has not been able to carry out the research for which it was established.
MMJ has been working on a gel capsule that contains cannabis extracts. The company claims it is meant to treat Huntington’s and multiple sclerosis. MMJ had previously been granted DEA approval to import marijuana from Canada into the U.S., but later requested permission to grow cannabis on its own for research and development.
The company claims that “this registration is crucial to MMJ’s capability to conduct FDA sanctioned clinical studies,” because without the ability of cultivating their own marijuana they are unable produce the correct compound.
MMJ claims that the DEA pre-registration for the license application started in June 2021, and lasted until October the following year. The suit states that “at the end of the trip, the diversion officer informed MMJ they would return to DEA, ‘write-up’ the report and submit it to their supervisor, who would then send the findings to DEA headquarters for a decision.”
According to the petition, there was never a final decision. The petition states that DEA staff have repeatedly tried to check on the status of registration approval decisions for manufacturing and have told MMJ they do not know when they will make a final determination.
When the company asked about the status of registration six months later in April 2022 “DEA personnel replied, ‘why are you asking? The filing claims that “DEA personnel responded, ‘why do you want to know? ‘”
The company says that while DEA found MMJ’s diversion and security plans “sufficient” for researcher registration, it was unable to determine the manufacturing registration of MMJ Cultivation for an “inexplicable” reason not communicated to MMJ.
Lawyers for MMJ claim that DEA has not met its obligations under federal laws, including the Medical Marijuana and Cannabidiol Research Expansion Act that President Joe Biden passed into law last year to expedite licensing.
The lawsuit states that the research bill, “mandated DEA responses to applications within a period of 60 days”, a time frame which, in MMJ’s case, is long past. The lawsuit claims that “DEA has flagrantly disregarded the deadlines set by the CSA, the MCREA and also ignored requests from the President of the United States.”
Duane B. Boise, MMJ’s President, said in a release before filing the lawsuit: “The question is why the DEA has failed to fulfill its legislative mandate?” Elio Mariani, the CEO of MMJ Company, pledged to “get to the bottom” of this issue at any cost.
Megan Sheehan, an attorney based in Barrington, Rhode Island, represents the company.
A federal judge in Rhode Island dismissed a civil lawsuit filed by the company against the government on November 20, 2022 for lack of subject-matter jurisdiction.
MMJ is not the only one frustrated by the long-winded cannabis bureaucracy of the federal government. Bipartisan members of Congress have been complaining about DEA delays for years.
Rep. Buddy Carter (R-GA) slammed DEA for its “epitome” of incompetence, saying that the agency “failed the American public” when it failed to reschedule marijuana.
One year later, 11 members of Congress from both parties sent a letter stating that DEA’s sluggishness cost America jobs.
This helped to accelerate the process and led to the passage in 2022 of a medical marijuana research bill. In recent years, more growers for research have been licensed. DEA’s website lists eight “bulk-approved marihuana producers” today, but critics claim production is still very limited.
Even DEA acknowledged some delays in government handling of marijuana issues. Last month, DEA administrator Anne Milgram pledged to ask the Department of Health and Human Services for a timetable on the ongoing review of the federal scheduling status of marijuana.
Milgram stated that DEA had not received a recommendation for marijuana’s scheduling from HHS. HHS is currently conducting a scientific review of the drug. Once the agency receives it, it will perform its own eight-factor analyses and invite public comments prior to making a final decision.
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.
View MMJ’s complete filing before the DC Circuit:
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Photo by Chris Wallis // Side Pocket Images.
The first time Marijuana Moment published the article Medical Marijuana Company Slams DEA in Lawsuit Alleging Extreme Delayed To Cannabis Research Licensing.
