EXCLUSIVE: DEA Stalling Hinders Critical Clinical Trials For Debilitating Conditions, Says MMJ BioPharma CEO

MMJ BioPharma Cultivation finds itself at the center of a pivotal legal struggle with the Drug Enforcement Administration (DEA), accusing the agency of significant delays in processing its application to grow marijuana for pharmaceutical research. The company's lawsuit claims these delays have hindered critical clinical trials aimed at developing treatments for debilitating conditions such as Multiple Sclerosis (MS) and Huntington's Disease (HD), thereby prolonging the suffering of patients who could benefit from cannabis-based therapies.

MMJ Struggles With DEA Delays

Duane Boise, president and CEO of MMJ International Holdings, explained to Benzinga that these delays have severely impacted the company's ability to cultivate the specific cannabis strains needed to produce active pharmaceutical ingredients (APIs). "Because the DEA has significantly delayed our DEA registration, MMJ has not been able to grow the specific marijuana plant cultivars utilized in the development of our API. There is currently no one in the United States growing specific cultivars to MMJ's pharmaceutical specifications," Boise noted. Even if MMJ could source these cultivars from other countries, it would still face roadblocks, as the company lacks the necessary DEA registration to process them within the U.S.

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Investments And Clinical Trials Stalled By Federal Obstacles

The delays have not only impacted research but also deterred investors. "We have had investors ready to invest but when they saw the DEA roadblocks, it delayed the investment, thus extending the research timelines," Boise added. Despite these challenges, MMJ has successfully developed a soft gelatin capsule, which is awaiting FDA approval. Once approved, it will be used in human clinical trials, but for now, the company's research is in limbo.

Boise also addressed the Department of Justice’s (DOJ) argument that MMJ's lawsuit lacks subject-matter jurisdiction, explaining that the DEA has already conducted and completed its investigation in Rhode Island, where MMJ holds the required licenses. He contends that the DOJ's claim is a diversion tactic meant to confuse the court.

Constitutional Issues Raised In MMJ Case

MMJ's legal case raises broader constitutional questions, particularly concerning the use of the Administrative Law Judges (ALJs) process used by the DEA in enforcement actions. Boise described the ALJ process as inherently biased: "When the Administrative Law Judge is judge, jury, and executioner how can this be impartial? The judge is blocking MMJ from questioning key DEA employees,” he remarked. Boise further emphasized that despite the marijuana research act, which mandates a 90-day timeline for approval or denial, the judge has consistently failed to address the significant delays.

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Moreover, MMJ BioPharma's legal position was bolstered by the recent Supreme Court ruling in Jarkesy v. SEC, which reaffirmed the right to a jury trial in cases involving federal agency enforcement. Boise sees this ruling as a critical turning point. "A fair impartial trial will not take place unless the court abides by the recent Supreme Court ruling – Chevron Deference. Ambiguity in the law is not for the interpretation of the DEA, however, the truth is, and having a federal court recognize the truth is the end game."

MMJ BioPharma Committed To Long-Term Fight

Although these delays have altered MMJ's timeline, Boise made it clear that the company is in this fight for the long haul. "Yes, it has delayed our implementation by five years. We are prepared for the long haul and will maintain and persevere until the government decides to act in accordance with the law," he said. MMJ says it hopes the outcome of this case will set a precedent for both cannabis research and federal cannabis policy. "The DEA cannot continue to keep moving the goal post by their biased interpretations," Boise concluded.

The outcome of MMJ BioPharma's lawsuit could have far-reaching implications not just for the company's research, but for the broader cannabis industry, especially as the DEA's rescheduling efforts progress.

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