MMJ Drug Maker Calls DEA Admin Judge Appointment Flawed

A DEA  Admin Law Judge will hit pause this week on an agency dispute with a manufacturer of medications treating Multiple Sclerosis and Huntington's disease patients, as MMJ BioPharma Cultivation plans to file a federal suit challenging her appointment.

Pending granting a stay request from MMJ BioPharma Cultivation Inc., Administrative Law Judge Teresa A. Wallbaum may say the particular circumstances of the case justified the move until a federal court makes a decision.

MMJ BioPharma Cultivation's challenge to this DEA tribunal's authority now allows federal courts to entertain interlocutory structural challenges, is a sufficiently new issue that makes it challenging to gauge the likelihood of success, she may state.

The anticipated order will come as MMJ is filing suit on the DEA in a federal court this week over a delayed DEA registration needed to produce final dose form botanical marijuana gel capsules to treat patients suffering from Multiple Sclerosis and Huntington's disease in FDA clinical trials.

MMJ will accuse the DEA of unconstitutionally attempting to delay its registrations as a manufacturer of medications and to delay its supplying medicine to suffering patients.

MMJ's complaint, which also targets the DEA, Department of Justice and other government defendants, alleges that, due to her unlawful appointment, Judge Wallbaum cannot adjudicate the DEA's attempt to rule on MMJ's applications. The company also seeks a declaration that the DEA process for appointing administrative law judges is unconstitutional.

"Everyone agrees that there is a need for drugs to treat these neurological diseases— Congress, the FDA, the DEA, the doctors, parents' association — everyone's saying the same thing," said MMJ Biopharma Cultivations president Duane Boise . "And here we have an administrative agency that just completely arbitrarily attacks a company that's following the law to manufacture a marijuana soft gelatin capsule to help suffering patients."

"This is insanity," Boise added. "Someone's got to act."

MMJ BioPharma Cultivation alleges that the process used by the DEA to appoint Judge Wallbaum was the same process the U.S. Supreme Court found unconstitutional in June 2018 in a case brought against the Securities and Exchange Commission.

"Neither the President of the United States nor the Attorney General of the United States appoints ALJs to their positions at DEA," MMJ said. "Thus, the DEA ALJs were appointed pursuant to a process that violates the Appointments Clause, a fundamental defect in the DEA's administrative enforcement process."

In her anticipated order, Judge Wallbaum will note that, under the U.S. Supreme Court's Axon ruling, subjecting a party to a proceeding that is ultimately found to be conducted within an unconstitutional structure can, standing alone, constitute legal harm.

The delays in approving legitimate marijuana clinical trials and research applications, as highlighted in the case of MMJ BioPharma Cultivation, can have far-reaching consequences. These delays not only hinder the progress of medical research but also impact the development of potential treatments for conditions like Multiple Sclerosis and Huntington's Disease. Patients who could potentially benefit from these treatments may be left waiting for relief due to bureaucratic hurdles.

The concerns about the DEA's alleged failure to follow congressional mandates for marijuana pharmaceutical development and clinical trials raise questions about the drug enforcement agency's accountability and transparency.

The accusations of the DEA acting in secrecy and maintaining a monopoly on marijuana cultivation for research purposes are troubling and warrant further investigation. Moreover, the legal challenges brought forth by MMJ BioPharma Cultivation, including allegations of unconstitutional processes in appointing administrative law judges, add another layer of complexity to the situation. If proven true, these allegations could have broader implications for the DEA's enforcement processes and decision-making authority.

The potential impact of this legal action

The potential impact of this legal action extends beyond the specific case of MMJ BioPharma Cultivation. It could set a precedent for how the DEA handles similar applications in the future and may prompt a reevaluation of its policies and procedures regarding marijuana research and development.

Ultimately, the outcome of these legal challenges and the broader discussions around marijuana policies under the Biden administration will shape the future landscape of medical research, patient access to treatments, and government oversight of controlled substances. It will be important to monitor how these developments unfold and how they may impact the broader cannabis industry and healthcare landscape.

MMJ BioPharma Cultivation is represented by Megan Sheehan of Sheehan Associates Law.