Cannabis pharma company RI sues DEA over research approval

The Federal Building and Courthouse in Providence, RI.

A Rhode Island cannabis research company is asking federal court to compel the federal government to approve the company’s requests to cultivate and import cannabis for medical research.

MMJ International, a company that hopes to develop and sell cannabis-based drugs, says the US Drug Enforcement Administration is dragging its feet on an approval, missing the 90-day deadline for the agency to act on requests.

“At the time of filing this petition and complaint, it has been over three years since the process began and the operation is currently stalled,” says the 19-page complaint filed April 8 in district court. American from Rhode Island. . “Countless patients who have been affected by multiple sclerosis and Huntington’s disease are waiting for the potentially life-saving treatments associated with the development of these pharmaceuticals.

[Download MMJ International’s complaint.]

For years, the DEA exclusively licensed the University of Mississippi to produce cannabis for research purposes, but the grow site earned a reputation for producing low-quality cannabis compared to what’s legally available in the US. States that have legalized adult use.

“Among the research community, it has long been recognized that the marijuana produced by the University of Mississippi was insufficient and of poor quality for pharmaceutical research and development,” the complaint said.

The DEA updated its cannabis research guidelines in 2016, to allow more facilities to apply for permission to grow cannabis for research. This change, which had been announced in the last year of Barack Obama’s presidency, was slowed when Donald Trump took office the following year.

Most recently, the DEA announced on May 14, 2021 that it would prioritize reviewing applications for these potential cultivators.

MMJ International applied for a cannabis research permit, as well as cultivation and import applications on December 27, 2018, according to the complaint.

The DEA has granted the Cannabis Import Permit from Canada, so that Catalant Pharma Solutions can process this material into a soft gel capsule to treat multiple sclerosis and Huntington’s disease. MMJ International announced a year ago that it had finished production of these capsules, but the company continues to wait for DEA approval to begin clinical trials with the capsules.

Meanwhile, MMJ International is also awaiting approval for bulk cultivation of its proprietary cannabis strains.

“MMJ Cultivation (a subsidiary of MMJ International) applied for a DEA bulk manufacturing registration specifically because they cannot import the specific strains/genetics of marijuana plants that are necessary for the cultivation and development of botanical pharmaceuticals accordance with the Botanical Drug Development Guidance issued by the FDA in 2016,” the complaint stated. “As such, MMJ cannot proceed with the development of the API as they are still awaiting regulatory approval. DEA on their Bulk Manufacturing Registration and Cultivation Approval”

Federal inspectors visited the company’s planned cultivation facility on October 24, 2021. In late January 2022, the DEA granted MMJ Labs a permit to conduct its research, but the company still does not have an approved source. of cannabis with which to conduct research. this research.

As of January 22, the DEA had not met the 90-day deadline for a decision following a final inspection.

“Unsurprisingly, that date has also passed and the DEA does not appear to be any closer to a final decision. As such, MMJ argues that something must be done to escalate this matter, hence this petition and complaint.

In terms of legal precedent, this case would not necessarily change the national landscape, especially since the US Legislature is currently working on a bipartisan cannabis research bill that would allow DEA-approved labs to obtain their Research cannabis from dispensaries in states where cannabis is legal.

The defendants include Attorney General Merrick Garland, the United States Drug Enforcement Administration and several members of DEA management. A DEA spokesperson did not respond to a post request for comment.

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