The lawsuit filed by MMJ BioPharma Cultivation against the Attorney General, DEA Administrator Anne Milgram, and the DEA Administrative Law Judge (ALJ) is intensifying, with significant legal arguments presented from both sides. MMJ BioPharma's primary grievances focus on the DEA's alleged delays and obstruction in approving applications for marijuana research and cultivation, crucial for pharmaceutical development, particularly for FDA-approved clinical trials targeting Multiple Sclerosis (MS) and Huntington's Disease (HD).
Delayed Approval and Procedural Violations
MMJ BioPharma contends that the DEA has violated the Controlled Substances Act (CSA) and the Medical Marijuana and Cannabidiol Research Expansion Act by failing to approve its marijuana research and cultivation application in a timely manner. This delay, MMJ claims, has caused significant financial harm to the company. Despite adhering to all DEA regulatory requirements-including filing two Investigational New Drug (IND) applications with the FDA-MMJ argues that the DEA's delays have significantly hindered progress in their clinical trials.
DEA Constitutional Violations:
MMJ BioPharma asserts that the use of DEA Administrative Law Judges (ALJs) violates their constitutional rights by denying them a fair and impartial hearing before a jury and judge. Citing the Supreme Court's decision in Jarkesy v. SEC, the lawsuit questions the constitutionality of federal agencies using ALJs without providing a fair impartial right to a jury trial.
DEA Bias and Shifting Standards:
MMJ accuses DEA Administrator Anne Milgram of personal bias against marijuana, as evidenced by her failure to sign the rescheduling hearing notice. The lawsuit alleges that Milgram's decisions and the administrative process have obstructed legitimate pharmaceutical research, thereby prolonging the suffering of patients who could benefit from medical marijuana treatments.
The DOJ and DEA's Defense:
The Department of Justice (DOJ) and DEA have responded with several arguments, many of which MMJ claims are attempts to further delay the process:
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Lack of Subject-Matter Jurisdiction:
The DOJ argues that the Court lacks jurisdiction to rule on MMJ's application because the DEA has not made a final decision. Without a final agency action, the DOJ contends, the case is not yet ripe for judicial review. -
Public Interest and Sufficiency of Allegations:
The DOJ claims that MMJ's complaint fails to demonstrate that granting the registration would be in the public interest. The DEA asserts that registrations are only approved if it is determined to be in the public interest, and MMJ has yet to meet that standard. -
Constitutionality of ALJ Protections:
The DOJ defends the constitutionality of the ALJ process, stating that ALJs only make recommendations, with the DEA Administrator making the final decision. They argue that MMJ has not shown any harm caused by ALJ removal protections, and therefore, the process does not infringe on their rights. -
Regulatory Necessity and Control of Substances:
The DOJ and DEA maintain that delays and strict controls are justified under the CSA, given that marijuana remains a Schedule I substance. They argue that these controls are necessary to regulate potentially harmful substances, and their actions are within the bounds of their legal authority.
MMJ's Counterarguments and Broader Implications
MMJ BioPharma counters that it has fulfilled all requirements to qualify for registration, having filed two INDs with the FDA and prepared for clinical trials. The company asserts that the DEA's delays are unjustified, describing the process as a "kangaroo court" that undermines legitimate medical research. MMJ believes that personal bias from DEA Administrator Anne Milgram is contributing to the harm inflicted on patients who would benefit from marijuana-based therapies.
For more information:
MMJ BioPharma Cultivation
www.mmjbiopharma.com