Last week, the federal government announced it would begin processing dozens of pending applications for the “steps necessary to improve access to marijuana research.”
The announcement came two days prior to the U.S. Drug Enforcement Agency (DEA)’s court-mandated response to a lawsuit brought by a cannabis researcher.
The petitioner, Dr. Sue Sisley, heads the Scottsdale Research Institute in Arizona. Dr. Sisley is seemingly frustrated by the University of Mississippi, inexplicably having the monopoly on federally-approved medical cannabis for research purposes. She believes the cannabis “Ole Miss” disseminates to other researchers is low-quality, which could detrimentally impact their research.
A response to the mandamus petition was filed on behalf of one of the defendants in the suit, Attorney General William P. Barr, by Assistant Attorney General William H. Hunt, on August 28, in the United States Court of Appeals for the District of Columbia.
The government’s response states that “If an applicant seeks to manufacture a schedule I or schedule II controlled substance ‘for use only in a clinical trial,’ the Administrator will ‘issue a notice of application not later than 90 days after the application is accepted for filing.’”
Moreover, Ass’t A.G. Hunt’s response states, “The notice will allow for a comment period, and 90 days after the comment period ends, the Administrator will ‘register the applicant, or serve an order to show cause upon the applicant in accordance with’ section 824(c). If the Administrator issues a show cause order, then the Administrator will provide ‘a statement of the basis for the denial’ of the application, will direct the applicant to appear at a hearing, and will notify the applicant ‘of the opportunity to submit a corrective action plan on or before” the hearing date.” The Administrative Procedure Act governs a hearing under the show cause order.
“Two important, positive developments are that our lawsuit succeeded in ending the DEA’s delays in facilitating this important research and that the DEA does not dispute a single point in our petition,” says one of Dr. Sisley’s pro-bono attorneys, Shane Pennington, JD.
According to the filing, Dr. Sisley theoretically prevails in breaking up the institutional monopoly on cannabis research. The DEA will accept and process applications for federal licenses, for additional research facilities to study cannabis.
However, as with most bureaucratic endeavors, the application process is arduous. Out of the 33 current applicants, many of them do not qualify, while the remainder might not necessarily win approval for various reasons. The DEA’s Division of Divergence and Control is in the process of reaching out to applicants to discuss their pending application status. In reality, applicants might be jammed up for years as they jump through hoops to be in compliance with the DEA’s guidelines.
“While the attorneys got the relief that they were seeking from DEA, they interpret the ‘rule making’ process as the Federal agencies’ codeword for ‘delay strategy,’” says Dr. Sisley.
Overall, Dr. Sisley refers to the government’s response as a partial victory. “This is definitely not a full victory until we see real world cannabis flower finally being used in FDA-controlled clinical trials.”
Dr. Sisley’s attorneys plan to file their response to the Federal government on September 11.
*This article was updated with exclusive quotes from Dr. Sue Sisley and one of her attorneys.