A federal court has ordered the Drug Enforcement Administration (DEA) to explain why it has not responded to nearly two dozen applications to grow cannabis for research purposes after Dr. Sue Sisley and the Scottsdale Research Institute (SRI) filed a lawsuit against the Justice Department and the DEA in June.
SRI, a Phoenix-based clinical trial company, applied for a DEA manufacturing license in 2016 to grow its own cannabis for an ongoing study on medical marijuana as a treatment for veterans suffering from post-traumatic stress disorder (PTSD).
The quality of cannabis supplied by the University of Mississippi—the only organization licensed to grow cannabis for medical research in the U.S.—was an ongoing issue during SRI’s PTSD study, the Phoenix New Times reported last year.
The DEA announced in August 2016 that it would start accepting new cultivation license applications and received 25 applications in the year following the announcement, but has not approved a single one. The DEA has said that it does not have a timeline to approve or deny the applications and that all applicants remain under review, according to a 2017 STAT report.
Since then, not much has changed.
Sisley and the SRI team sued the DEA and the Justice Department in June, arguing that the quality of the cannabis provided by the University of Mississippi is preventing SRI from conducting meaningful research on potential applications for cannabis. The lawsuit asks the judge to force the DEA to respond to applicants seeking cultivation licenses.
“To comply with federal law, SRI must use federally-sourced cannabis, grown exclusively on a single 12-acre farm run by the University of Mississippi,” the complaint reads. “SRI used this cannabis for its Phase II trials. It arrived in powdered form, tainted with extraneous material like sticks and seeds, and many samples were moldy. Whatever reasons the government may have for sanctioning this cannabis and no other, considerations of quality are not among them. It is not suited for any clinical trials, let alone the ones SRI is doing. Simply put, this cannabis is sub-par.”
The case goes on to say that SRI applied to grow its own cannabis for clinical trials and other research projects, which would have improved quality and allowed the organization to more tightly regulate dosages, but the DEA has yet to respond, and SRI simply cannot wait any longer.
“SRI turns to this Court having exhausted all other avenues of relief,” the complaint reads. “Sisley reached out to the agency no fewer than five times, the media has done a full-court press, and the number of letters from frustrated members of Congress from both parties imploring the agency to act is quickly approaching a dozen. At this juncture, nothing short of a writ from this Court compelling the agency to act will stop the ongoing harm caused by DEA’s unlawful and unreasonable delay.”
Now, a federal court is demanding answers.
The U.S. Court of Appeals for the District of Columbia Circuit has ordered the DEA to explain why it has not responded to the dozens of applications it has received from prospective growers, who applied nearly three years ago to cultivate cannabis for research.
“Hopefully, DEA will finally explain, in a court-filing available for public inspection, the answer to this question that has frustrated everyone,” Sisley said in a public statement following the ruling.
The DEA has until Aug. 28 to respond to SRI’s lawsuit. The industry anxiously awaits what the agency has to say.
“The DEA needs to clarify how interested parties can obtain legal cannabis for research purposes,” Dr. Jayashree Mitra, attorney with Zuber Lawler, told Cannabis Business Times. “With FDA’s approval of Epidiolex for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, there is little justification to delay research into the medical benefits of cannabinoids. The lawsuit will hopefully clarify the regulatory processes and allow the legal domestic cannabis companies to work with the medical and pharmaceutical industry to address their research and development needs.”
“Dr. Sisley’s lawsuit is based on common sense and scientific norms,” added Steve Gormley, president and CEO of International Cannabrands. “The issue she confronts is the government monopoly on producing cannabis for research. Dr. Sisley’s lawsuit is up against an incredible bureaucracy but she’s certainly on the right side of the issue.”
Michael Sassano, founder and CEO of Nevada-based cultivator Solaris Farms, is less optimistic about the DEA’s response.
“Dr. Sue Sisley’s current motion will likely derive an answer which will fall in line with current federal ambiguity,” he said. “Researchers are leaving the U.S. to develop in less corrupted environments that recognize cannabis as a proven medicine [and] that health decisions based on old mythology should not be in the hands of the DEA.”
In the meantime, the National Institute on Drug Abuse announced plans in June to grow more than 4,400 pounds of cannabis this year at the University of Mississippi—the largest crop in five years.
In addition, several lawmakers have introduced federal legislation to remove the obstacles to cannabis research, most recently with U.S. Sen. Dick Durbin’s Expanding Cannabis Research and Information Act, which would reclassify marijuana as a Schedule III controlled substance under the Controlled Substances Act.
Published at Tue, 06 Aug 2019 20:33:00 +0000