Merick Garland, DEA Director Anne Milgram, Al Judge Under Federal Court Summons Over DEA Failed Marijuana Policy

DEA STYMIED MARIJUANA DRUG DEVELOPMENT – HOWEVER FDA MOVING FORWARD ON CANNABIS DRUG DEVELOPMENT FOR HUNTINGTON’S DISEASE

“We are prepared for the long haul and will continue our efforts until the government acts in accordance with the law,” Boise affirmed
 

WASHINGTON, DC / ACCESSWIRE / January 6, 2025 / MMJ International Holdings, recognized for its pioneering efforts in marijuana-derived pharmaceuticals, has made significant headway with the FDA in developing a cannabis treatment for Huntington’s Disease and Multiple Sclerosis. However, their progress faces substantial roadblocks due to the DEA’s persistent delays in processing their cultivation applications, creating a stark contrast between the cooperation received from the FDA and the obstacles imposed by the DEA.

FDA Collaboration Highlights

Duane Boise, President and CEO of MMJ International Holdings, commends the FDA for its clear regulatory pathway that facilitates the development of marijuana-based medicinal products. The FDA’s structured approach has allowed MMJ to push forward with their Investigational New Drug (IND) applications, demonstrating a commitment to rigorous standards for safety, efficacy, and consistency in drug development. “The federal government provided a very detailed regulatory pathway to move forward to prove the safety and efficacy of a marijuana product,” Boise stated, underscoring the FDA’s support in their quest to secure pharmaceutical drug approvals.

DEA’s Delays Stifle Progress

Contrasting sharply with the FDA’s supportive stance, the DEA’s sluggish processing times have severely impeded MMJ’s ability to perform crucial clinical trials. These delays hinder the cultivation of specific cannabis strains essential for their research, effectively stalling the development of active pharmaceutical ingredients (APIs) necessary for their groundbreaking treatments. Boise expressed frustration over the blockade, noting, “MMJ has not been able to grow the specific marijuana plant cultivars needed for our API development due to significant delays in our DEA registration.”

Impact on Investment and Clinical Trials

The DEA’s inefficiencies have not only affected MMJ’s research activities but also have chilled potential investment opportunities. Investors hesitant to commit funds due to these regulatory uncertainties have further delayed the research timelines, leaving promising patient treatments in limbo. Despite these challenges, MMJ has successfully developed a soft gelatin capsule, now awaiting FDA approval, poised to advance to human clinical trials in HD once FDA cleared.

Legal and Regulatory Battles

Boise also highlighted the broader constitutional issues arising from their legal challenges with the DEA, particularly criticizing the biased procedures in the Administrative Law Judges (ALJs) process used by the DEA in enforcement actions. The recent Supreme Court ruling in Jarkesy v. SEC, reinforcing the right to a jury trial in cases involving federal agency enforcement, supports MMJ’s stance for a fair and impartial trial, challenging the DEA’s interpretative over-reach.

MMJ’s Resolute Long-Term Commitment

 DEA STYMIED MARIJUANA DRUG DEVELOPMENT – HOWEVER FDA MOVING FORWARD ON CANNABIS DRUG DEVELOPMENT FOR HUNTINGTON’S DISEASE “We are prepared for the long haul and will continue our efforts until the government acts in accordance with the law,” Boise …  Read More  

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