Two Rhode Island labs sue DEA over pharmaceutical licensing of marijuana

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Two Rhode Island cannabinoid research labs are suing the DEA for obstructing what they see as the crucial development of pharmaceutical-grade cannabis products for use in clinical trials for the treatment of multiple sclerosis plaque and Huntington’s disease.


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The companies say the DEA has long missed deadlines for making a decision and has delayed progress from the start, say scientists at the labs in question MMJ BioPharma Cultivation Inc., MMJ International Holdings Corp., who now say it it’s time to take legal action. .

“The three years that have passed since the initial applications were submitted could have been used for more research and development, working on clinical trials, etc. Instead, however, that time was used to fight for a decision that should have been made two years ago under regulations,” the companies state in their filing.

“The DEA, however, seems to be dragging its feet despite MMJ’s consistent and almost authoritative commitment to excellence that goes far beyond mere compliance with DEA ​​regulations and protocols.”

The companies confirm that they have met all requirements to obtain licenses and have complied with stringent FDA guidelines to produce pharmaceutical grade softgels.

RELATED: DEA ends federal monopoly on research cannabis production after more than 50 years

What’s in the lawsuit?

The companies behind the lawsuit are seeking to compel the DEA to act on their demands to manufacture and import specific strains of marijuana in bulk to treat the two degenerative diseases.

“Countless patients who have been impacted by multiple sclerosis and Huntington’s disease are awaiting the potentially life-saving treatments associated with the development of these pharmaceuticals,” the MMJ entities wrote in federal court filings. “The DEA, however, seems to be dragging its feet despite MMJ’s consistent and almost authoritative commitment to excellence that goes far beyond mere compliance with DEA ​​regulations and protocols.”

Although the lab received DEA approval in January 2022 as a Schedule 1 Analytical Laboratory Research Facility, it has not received DEA approval for bulk manufacturing and l importation of strains needed for the production of botanical pharmaceuticals in accordance with FDA guidelines, according to the filing.

Duane Boise, the companies’ chairman, said they had gone to “extreme” efforts to secure the licenses and comply with stringent Food and Drug Administration guidelines.

“The DEA is inhibiting manufacturing… It’s wrong,” Boise said.

MMJ names Attorney General Merrick Garland, DEA Administrator Ann Milgram, Providence DEA investigator Tom Cook, and the DEA itself as defendants.

A DEA spokeswoman declined to comment because litigation is ongoing.

Boise highlighted nationwide interest in pharmaceutical drugs derived from marijuana. In 2016, the DEA passed a policy to increase the number of entities licensed under the Controlled Substances Act to grow marijuana to provide legitimate research involving marijuana and its chemical constituents.

Boise said that’s exactly what he and his team intend to do, but believe they’ve been blocked by investigators who are “not advocates” for marijuana.

In response to numerous inquiries, DEA staff said they don’t know when a decision will be made.