It’s a very litigous week- here’s another one.
WASHINGTON, Sept. 10, 2024 – PRESS RELEASE – The lawsuit filed by MMJ BioPharma Cultivation against the Attorney General Merrick Garland, Drug Enforcement Administration (DEA) Administrator Anne Milgram, and a 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 and Huntington’s Disease.
Key Points of MMJ BioPharma Cultivation’s Lawsuit
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 BioPharma argues that the DEA’s delays have significantly hindered progress in its clinical trials.
DEA Constitutional Violations:
MMJ BioPharma asserts that the use of DEA administrative law judges violates its constitutional rights by denying the company 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 BioPharma accuses 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.
