DEA sued by Rhode Island Lab for “foot dragging” in marijuana pharmaceutical licensing
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Two Rhode Island cannabinoid research labs are suing the DEA for getting in the way of what they say is critical to the development of pharmaceutical-grade cannabis products for use in clinical trials to treat multiple sclerosis and Huntington’s disease.
The companies argue that the DEA has long exceeded deadlines to issue a decision and delayed progress from the start, say scientists at the labs involved: MMJ BioPharma Cultivation Inc. and MMJ International Holdings Corp., who now say it’s time for is legal action.
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“The three years that have passed since the first applications were submitted could have been used for more research and development, conducting clinical trials, etc. Instead, however, that time was used to fight for a decision that should have been made over two years ago under the regulations,” the companies say in their filing.
“However, DEA seems to be dragging its feet despite MMJ’s constant and almost overbearing commitment to excellence, which goes well beyond mere compliance with DEA regulations and protocols.”
The companies confirm that they have met all requirements to obtain licenses and adhered to strict FDA guidelines to manufacture pharmaceutical grade soft gel capsules.
What’s in the lawsuit?
The companies behind the lawsuit are attempting to force the DEA to honor their requests to mass produce and import specific strains of marijuana to treat the two degenerative diseases.
“Countless patients affected by multiple sclerosis and Huntington’s disease await the potentially life-saving treatments associated with the development of these drugs,” the MMJ entities wrote in federal court filings. “However, DEA seems to be dragging its feet despite MMJ’s constant and almost overbearing commitment to excellence, which goes well beyond mere compliance with DEA regulations and protocols.”
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According to the filing, while the laboratory received DEA approval as a Schedule 1 analytical laboratory research facility in January 2022, it has not received DEA approval to mass manufacture and import strains required to manufacture botanical medicinal products under FDA guidelines .
Duane Boise, president of the companies, said they took “extreme” efforts to secure the licenses and comply with the Food and Drug Administration’s strict guidelines.
“The DEA is inhibiting production… That’s wrong,” Boise said.
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MMJ names as defendants Attorney General Merrick Garland, DEA Administrator Ann Milgram, Providence DEA investigator Tom Cook, and the DEA itself.
A spokeswoman for the DEA declined to comment as the lawsuit is pending.
Boise highlighted the national interest in marijuana-derived drugs. In 2016, the DEA passed a policy aimed at increasing the number of marijuana-growing companies licensed under the Controlled Substances Act to conduct legitimate research involving marijuana and its chemical components.
Boise said that’s exactly what he and his team intend to do, but believe they’ve been stymied by investigators who are “not proponents” of marijuana.
DEA employees responded to numerous inquiries that they did not know when a decision would be made.
This article originally appeared on Benzinga and has been republished with permission.
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