DEA Set to Allow More Facilities to Produce Marijuana for Research: A Victory for Cannabis Growers, Researchers and the DEA? | Womble Bond Dickinson

DEA Set to Allow More Facilities to Produce Marijuana for Research: A Victory for Cannabis Growers, Researchers and the DEA? | Womble Bond Dickinson

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Although many states have legalized marijuana for medicinal and/or recreational use, when it comes to using marijuana in a research setting, sources have been very limited.  The US Drug Enforcement Administration (DEA) has the authority to register manufacturers of marijuana, or cannabis, a Schedule 1 controlled substance under the Controlled Substances Act.  Since 1968, the DEA has approved only one supplier of research marijuana—the National Center for the Development of National Products, at the University of Mississippi.  And their production is exclusive for National Institute on Drug Abuse (NIDA).

That monopoly is about to change.  On May 14, 2021, the DEA announced that it would soon be allowing other growers to manufacture marijuana for research purposes.  The DEA has sent Memorandums of Agreement (MOAs) to manufacturers meeting the appropriate legal standards, outlining protocols to allow applicants and the DEA to work together to produce, store, package and distribute marijuana under the new regulations.  After the MOAs are finalized, the DEA plans to issue registrations to manufacturers who will then be authorized to cultivate and supply marijuana for more than 575 DEA-licensed researchers in the US.

Many researchers are elated to hear this news.  Some researchers have criticized the NIDA cannabis as being inadequate for research settings due to lack of potency, quality and diversity in strains.  In a press release on March 2020, the DEA, noting that 37 pending applications were being reviewed, stated its belief that “registering more growers will advance the scientific and medical research already being conducted.” 

While having more growers may facilitate clinical trials and the development of marijuana-based drug therapies, the role of the DEA in the marijuana supply chain does raise concerns.  According to the DEA’s proposed regulations, the DEA would not only enforce laws regulating marijuana production and distribution.  They would also take an active role in purchasing, possessing and selling marijuana for use in clinical research.

According to the proposed rules presented in the 2020 Controls To Enhance the Cultivation of Marihuana for Research in the United States, the DEA would “take possession of marijuana after harvest; and maintain the exclusive right to import, export, wholesale trade and maintain stocks of marijuana and its resin.”  The question of whether the DEA can participate in activities which they also regulate has led to the suggestion that the DEA “delegate as many of these proposed new responsibilities to registered entities who are better equipped to engage in these activities.” On the other hand, the “DEA already has a mechanism for allowing manufacture and distribution of other tightly regulated drugs for clinical research, including MDMA, LSD, and psilocybin, each of which has been studied as a potential treatment for conditions such as PTSD and depression”. 

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