Providence Journal - As reported by Katie Mulvaney - Investigative Reporter
MMJ BioPharma Cultivation is anticipating the imminent DEA approval for its federal API Bulk Manufacturing Registration
PROVIDENCE, RI / ACCESSWIRE / April 12, 2022 / A Rhode Island laboratory is asking the federal court to intervene with the U.S. Drug Enforcement Administration in its quest to grow pharmaceutical-grade marijuana for use in clinical trials into treatments for Multiple Sclerosis and Huntington's Disease.
MMJ BioPharma Cultivation Inc.; MMJ International Holdings Corp.; and MMJ BioPharma Labs Inc. - companies dedicated to developing pharmaceutical cannabinoid-derived medical treatments - wants the court to compel the DEA to act on its applications for bulk manufacturing and importing of specific strains of marijuana, arguing that the government has long passed the deadlines to issue a decision and has delayed its progress from the get-go.
The companies, which operate in Rhode Island, allege that the delays have brought crucial work to produce soft-gel capsules for clinical trials to a standstill.
"Countless patients who have been affected by Multiple Sclerosis and Huntington's Disease and are waiting on the potentially life-restoring treatments associated with the development of these pharmaceuticals," the MMJ entities wrote in federal court papers. "The DEA, however, appears to be dragging their feet despite MMJ's constant and almost overbearing commitment to excellence that exceeds far beyond mere compliance with the DEA's regulations and protocols."
"MMJ has been actively pursuing the path to develop treatments to lessen the impact of these degenerative diseases. The three years that have passed since submitting the initial applications could have been used toward more research and development, working the clinical trials, etc. Instead, however, this time has been used to fight for a determination that should have been made over two years ago under the regulations," the companies say.
While the lab received DEA approval in January 2022 as a Schedule 1 analytical lab research facility, it has not gotten DEA approval for bulk manufacturing and importing of strains that are required to produce botanical pharmaceuticals in keeping with FDA guidelines, according to the filing.
MMJ estimated that 200,000 Americans are diagnosed with Primary Progressive Multiple Sclerosis and another 30,000 with Huntington's Disease.
Duane Boise, president of the companies, said in a phone conversation Monday that they have taken "extreme" efforts to secure the licenses and comply with rigorous Food and Drug Administration guidelines to produce a pharmaceutical-grade soft gel capsules.
"The DEA is inhibiting manufacturing … It's wrong," he said
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 comment because the litigation is pending.
Boise emphasizes interest on a national scale in pharmaceutical drugs derived from marijuana. In 2016, the DEA adopted a new policy that is designed to increase the number of entities licensed under the Controlled Substances Act to grow marijuana to supply legitimate research involving marijuana and its chemical constituents.
Boise says that is exactly what he intends to do, but believes he's been stymied by investigators who are "not advocates" of marijuana.
According to MMJ's federal complaint, MMJ in November 2017 submitted protocols to the FDA to conduct clinical trials on the neurodegenerative diseases, MS and Huntington's disease. The plans won FDA approval, pending the outcome of analyses that needed an OK from the DEA for MMJ to grow particular proprietary strains of marijuana.
MMJ applied in December 2018 to the DEA for licenses to import plants from Canada to grow in bulk at the Rhode Island site. In November 2019 it received DEA approval to import a limited amount of extracts.
MMJ worked with a Pharma Solutions Company to complete a batch of soft-gel capsules, and is in the process of reporting the scientific findings to the FDA to proceed with clinical trials and ultimately win FDA approval for its products, the filing states.
MMJ, however, cannot get there without the DEA licenses that the company says are essential to its ability to conduct FDA-sanctioned clinical trials.
Investigators from DEA visited the lab in June 2021 and again Oct. 24,2021 to inspect the security system and the facility itself, boring into such details as the thickness of concrete under its flooring to prevent diversion. MMJ officials were told in October that the fieldwork portion of the review was complete and that a report would be submitted for final determination.
In response to numerous inquiries, DEA personnel have said that they don't know when a decision will be made. Congressman Jim Langevin reached out to the DEA on MMJ's behalf in February - an inquiry, like others placed by MMJ, that has gone unanswered, MMJ says.
SOURCE: MMJ BioPharma Cultivation