MMJ BioPharma Cultivation is in a legal battle with the Drug Enforcement Administration (DEA), accusing the agency of unjustifiable delays in processing its application to cultivate marijuana for pharmaceutical research. The company asserts these delays have impeded critical clinical trials aimed at developing treatments for debilitating conditions such as Multiple Sclerosis (MS) and Huntington's Disease (HD).
Impact of DEA Delays on Research and Investment
Duane Boise, president and CEO of MMJ International Holdings, stated that the delays have severely impacted the company's ability to cultivate specific cannabis strains needed to produce active pharmaceutical ingredients (APIs). According to Boise, there is currently no entity in the United States growing specific cultivars to MMJ's pharmaceutical specifications. The delays have also deterred potential investors, further extending research timelines.
Despite these challenges, MMJ has developed a soft gelatin capsule awaiting FDA approval for use in human clinical trials. However, the DEA's inaction has placed the company's research in limbo.
Constitutional Issues and Allegations of Bias
MMJ's lawsuit raises constitutional questions regarding the use of Administrative Law Judges (ALJs) by the DEA in enforcement actions. Boise described the ALJ process as inherently biased, stating that the judge is blocking MMJ from questioning key DEA employees. He also 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 delays.
The company's legal position is supported 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, asserting that a fair and impartial trial is essential.
MMJ BioPharma's Commitment
Boise affirmed the company's commitment to the long-term fight, stating that MMJ is prepared to persevere until the government acts in accordance with the law. The company hopes the outcome of this case will set a precedent for both cannabis research and federal cannabis policy, preventing the DEA from continually moving the goal post through biased interpretations.
The DEA and Department of Justice (DOJ) argue that the case is not yet ready for judicial review, as the DEA has not yet made a decision on MMJ's application. They also contend that MMJ has failed to demonstrate that its registration would serve the public interest. The DEA maintains that its ALJs only make recommendations and that the agency retains final authority to make decisions.
