In a reversal of nearly five decades of policy, and almost five years after a former University of Arizona professorโs initial application, the U.S. Drug Enforcement Agency granted preliminary approval for the cultivation of marijuana for clinical research.
The DEA announced last Friday that it had approved the applications of several companies, including one for Phoenix-based Scottsdale Research Institute, a lab run by former University of Arizona professor and renowned marijuana researcher Dr. Sue Sisley, to grow and clinically test marijuana, opening a path for researchers to test its medicinal applications.
โThe Drug Enforcement Administration took an important step to increase opportunities for medical and scientific research,โ the agency said in a press release. โPending final approval, DEA has determined, based on currently available information, that a number of manufacturersโ applications to cultivate marijuana for research needs in the United States appears to be consistent with applicable legal standards and relevant laws.โ
For Sisley, who has spent her career advocating for such a move, the decision isnโt the finish line, but is a welcome win.
โNow we have to finalize the MOA,โ Sisley said, referring to the memorandum of agreement. โThen we will be issued a license to cultivate after that document is complete. They made clear that, you know, this is the first attempt to license any growers outside of Mississippi for the first time in decades.โ
Until now, the National Institute on Drug Abuse, or NIDA, had what amounted to a government-granted monopoly on the production and supply of marijuana for research purposes.
Although not officially a regulatory agency, NIDA had de facto control of the supply of marijuana that is FDA-approved for research purposes and grown at the University of Mississippiโs Research Institute of Pharmaceutical Sciences.
The DEAโs decision Friday ends that. Sisley said the decision should be a boon to scientists, doctors and researchers who are not approaching marijuana from a safety and regulatory mindset.
โTheyโve always been focused on cannabis for safety studies, looking at harmful side effects of cannabis and addiction potential,โ she said. โFor maybe the last decade, thereโs been a growing demand from the public to study cannabis as a medicine and not just as a drug of abuse.โ
SRI โ the company Sisley is the founder, owner, president and principal investigator for โ states on its website that it โsupports the expansion of research efforts to determine the applicability of cannabis as medicine for any conditions for which it might prove safe and effective.โ
Sisley also noted that SRI is currently conducting the only FDA-approved research into the effects of marijuana on Post-traumatic Stress Disorder in military veterans.
Attorney Matt Zorn, who represents SRI, said he sees the decision as the DEA and federal government beginning to embrace different, diverse supplies of cannabis for clinical and medical research purposes.
โItโs important because the research thus far has focused on safety and has used what can only be described as bad cannabis,โ he said.
Sisley echoed that sentiment about the existing supply of research-grade marijuana being low quality. She said that, during past clinical trials she put on, โmolding, diluted cannabis from the University of Mississippiโ performed poorly.
โItโs not that it didnโt just perform well, but it never was able to replicate the positive, transformative experiences that people were describing in the real world,โ she said.
The decision by the DEA on Friday should also help to pump more research-grade marijuana into supply as other institutions market their marijuana to researchers, Zorn said.
โThe idea isnโt that everyone is getting approved to supply themselves,โ he said. โInstead this is going to create a more robust marketplace where researchers can test different types of cannabis.โ
Sisley confirmed that while SRI is focused on growing marijuana for their clinical studies, excess flower and other products the firm produces will be made available at cost to other researchers and institutions looking to run their own studies.
โThat wasnโt our primary mission, but we certainly care. We desperately want to support scientists across the country,โ Sisley said.
