December 2, 2021

Volume XI, Number 336

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

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”. 

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume XI, Number 174
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About this Author

Sara Tucker Complex Products Liability Litigation Attorney Womble Bond Dickinson Atlanta, GA
Partner

Sara Tucker concentrates her practice on complex products liability litigation with a focus on pharmaceutical and medical device litigation.  A veteran trial lawyer, Sara has experience defending clients in high-stakes mass tort and multi-district cases in federal and state courts.  She also has experience in consolidated state court litigation, consumer class actions and medical malpractice.

The American Bar Association’s Young Lawyers Division selected Sara for its “On the Rise – Top 40 Young Lawyers” award in 2019, and Georgia Super Lawyers magazine has recognized Sara as a...

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Research Consultant

*Dr. Malpass is not licensed to practice law. Her activities are directly supervised by members of the firm licensed to practice law in the firm’s Winston-Salem office.

Gloria analyzes scientific and biomedical publications and documents to evaluate the validity and relevance of published data, and develops cross-examination key points that support or challenge the potential claims of plaintiffs and defendants. Her diverse experience includes providing technical support in the quality division of an FAA-regulated industry, conducting research related to alcohol dependence,...

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Madeline Campbell PhD Litigation Consultant Womble Bond Dickinson Winston-Salem
Litigation Consultant

Madeline has a Ph.D. in Cognitive Psychology. Her scientific background affords a considerable understanding of the complex scientific issues that are central in many types of litigation. She brings clarity to these technical subjects as she assists counsel in identifying relevant scientific themes and selecting strategies to best defend their cases. Madeline is often called upon for difficult cases that depend on presenting and attacking expert testimony. She has helped prepare counsel in a wide array of matters, from simple personal injury to complex multi-party civil...

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