A biopharmaceutical company is suing the Drug Enforcement Administration (DEA) over what it called unjustified delays to its application to launch clinical trials into cannabis treatments for Multiple Sclerosis (MS) and Huntington’s Disease (HD).
MMJ BioPharma Cultivation has filed a lawsuit against the DEA, its administrator Anne Milgram and the Attorney General for allegedly violating the Controlled Substances Act (CSA) and the Medical Marijuana and Cannabidiol Research Expansion Act.
In its lawsuit, filed on September 10, MMJ BioPharma says that prolonged inaction by the DEA caused significant financial harm to the company, and unduly delayed research that could alleviate patient suffering.
MMJ says that despite meeting all the regulatory requirements to begin research, including submitting two Invetsigational New Drug (IND) applications with the FDA, the DEA failed to process its application in a timely manner.
Going beyond its own financial losses, the case also brings the use of DEA Administrative Law Judges (ALJs), who handle disputes, into question.
The company, which is being represented by attorney Megan Sheahan and Associates, claim that the use of ALJs undermines their right to a fair trial, referring to the process as a ‘kangaroo court’.
Furthermore, in a notable reference to the ongoing debate surrounding the DEA’s role in US cannabis rescheduling, the suit accuses Milgram of personal bias against cannabis research, citing its own case as evidence.
In response to the accusations, the DEA and Department of Justice (DOJ) have stated that as the DEA is yet to come to a decision on MMJ’s application, the case is not yet ready for judicial review.
The regulator also argues that MMJ has failed to demonstrate that their registration would serve the public interest, a key requirement in obtaining approval for cannabis research, though MMJ contends that it is certainly in the interest of those suffering with the conditions it is researching.
On the use of ALJ’s, the DEA states that these judges only make recommendations, and that it retains final authority to make decisions, so any claims of undue process are irrelevant.
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