For more than five decades, a government monopoly on the manufacture of cannabis has held back clinical research into the use of cannabis. Currently, a single 12-acre farm run by the University of Mississippi is the sole domestic source of cannabis for FDA approved clinical research. Researchers familiar with this government cannabis have described it as inadequate for rigorous clinical studies, and a research paper concluded that this cannabis had more in common with hemp than the cannabis that can be found in dispensaries nationwide. Scottsdale Research Institute, run by Dr. Sisley, used this government cannabis for its recent FDA approved clinical trial into the safety and efficacy of cannabis for treatment-resistant PTSD and found it to be grossly inadequate.
Recognizing the disparity between this cannabis and the cannabis sold in medical dispensaries around the country, in 2016, the DEA announced it would accept applications from private entities to grow cannabis for clinical research. And yet, for three years, despite receiving over 30 applications, including an application from Scottsdale Research Institute in late 2016, the agency had processed none.
In June 2019, Matthew Zorn and Shane Pennington on behalf of Scottsdale Research Institute filed an action in the D.C. Circuit Court of Appeals requesting a writ of mandamus to order the Drug Enforcement Agency to process its application to grow cannabis for its clinical research. In late July, the court entered an order requiring the agency to respond by Wednesday, August 28. Two days before the DEA’s court-ordered response explaining why it had not processed SRI’s three-year-old application was due to in the U.S. Court of Appeals for the D.C. Circuit, the DEA processed not only SRI’s application, but all 33 pending applications to grow cannabis for research purposes. Along with the notice, DEA also announced it would issue new guidelines to govern registration to grow cannabis for clinical research.
Dr. Sisley is cautiously optimistic and considers this to be a victory. As a result of this lawsuit, the five-decade National Institute on Drug Abuse monopoly on growing cannabis appears to be moving toward an end, and the work of conducting robust clinical trials involving medical-grade cannabis can finally begin.
After three years of near silence, the developments from the DEA are a critical first step in ensuring that scientists in this country will be able to use true medicinal-grade cannabis for research.