MMJ BioPharma Cultivation is suing the Drug Enforcement Administration (DEA) over what it claims are unjustified delays in its application to start clinical trials for cannabis-based treatments for Multiple Sclerosis (MS) and Huntington’s Disease (HD).
The lawsuit, filed on September 10, names the DEA, its administrator Anne Milgram, and the Attorney General as defendants. MMJ alleges they violated the Controlled Substances Act (CSA) and the Medical Marijuana and Cannabidiol Research Expansion Act by failing to act on the company’s application.
According to MMJ, the DEA’s prolonged inaction has caused significant financial harm and delayed potentially life-changing research for patients. The company says it has fulfilled all regulatory requirements to begin the trials, including submitting two Investigational New Drug (IND) applications with the FDA, but the DEA has not processed its application in a reasonable timeframe.
The lawsuit also questions the role of DEA Administrative Law Judges (ALJs), who oversee disputes, arguing that their use denies MMJ a fair trial, describing the process as a "kangaroo court."
Additionally, the company accuses DEA Administrator Anne Milgram of personal bias against cannabis research, using their case to highlight broader concerns about the DEA's role in delaying cannabis rescheduling efforts.
In response, the DEA and Department of Justice (DOJ) argue that since no decision has yet been made on MMJ’s application, the case is not ready for judicial review. They also assert that MMJ has not demonstrated that its research would serve the public interest, a necessary condition for approval, though MMJ disputes this, pointing to the potential benefits for patients suffering from MS and HD.