For those of you who may have missed the classic rom-com “When Harry Met Sally,” there are several scenes in the movie when Carrie Fisher’s character laments, about the married man she has been dating for years, “I don’t think he’s ever going to leave her.” Her exasperated friend Sally, played by Meg Ryan, finally states what we all know to be true: “Marie, no one thinks he is ever going to leave her.” Is this where we’ve landed with the DEA, which stubbornly clings to the University of Mississippi as the sole approved cultivator of cannabis for U.S. research?
The DEA is not the only agency at fault; a host of federal government agencies have contributed to the chokehold on cannabis research in the United States, including the DEA, the Food and Drug Administration and the National Institute on Drug Abuse (NIDA). And cannabis research projects funded through the National Institutes of Health (NIH) must be prepared to jump through additional hoops. The FDA, NIDA and NIH are all part of the massive U.S. Department of Health and Human Services, while the DEA is an agency of the U.S. Department of Justice. Working together, these agencies have created a byzantine system that has rendered meaningful, peer-reviewed, therapeutic research of cannabis in the United States nearly impossible.
In federal fiscal year 2018, the NIH funded hundreds of cannabis research projects. Every single one of those projects, together with any non-NIH funded projects, were required to use cannabis sourced from a DEA-approved and registered cannabis cultivator. How many cultivators have been approved by the DEA or its predecessor agencies since 1968? One. NIDA contracts with the University of Mississippi to grow the entire supply of cannabis that is used in all U.S. research. And let’s be clear: According to researchers, the cannabis grown at Ole Miss is of questionable quality, bearing little resemblance to the cannabis available in states that have legal programs.
How can this be? The answer lies, in part, by understanding the powerful role of NIDA and the DEA in the U.S. cannabis research chain.
NIDA was born out of the “War on Drugs” in 1974, with its stated mission to “advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health.” [Emphasis added.] The goal of this organization, stated prominently on its website, is to facilitate research in order to teach us about addiction and abuse. NIDA does not exist to further our knowledge of the therapeutic properties of cannabis, although ironically NIDA research has yielded numerous cannabis studies revealing positive medical benefits. With an understanding of NIDA’s mission, no one should be surprised that the pace of approvals and access to the sole source of U.S. cannabis for research purposes is sluggish at best.
The DEA was established in 1973 as an integral part of the Nixon-era drug reform laws. Similar to NIDA’s focus on drug abuse, the DEA was created to combat drug trafficking and enforce the Controlled Substances Act. Unless cannabis is removed from Schedule I of the Controlled Substances Act (reserved for drugs that have no currently accepted medical use), the DEA will continue to hold power in determining the breadth and depth of cannabis research in the U.S.
In 2016, the DEA announced that it was open to expanding the list of approved cultivators and started an application process. Thirty-three applications have been received to date, but it appears that the DEA has no real interest in reviewing or approving any of them. Meanwhile, Ole Miss continues to enjoy its cultivation monopoly. In 2015, the University of Mississippi was once again awarded the contract by NIDA to be the federal government’s sole cannabis cultivator following what NIDA described as a competitive request for proposal procedure.
The DEA justifies its refusal to act by hiding behind the provision of the Controlled Substances Act limiting the number of cultivators to those that can “produce an adequate and uninterrupted supply” of cannabis. Recent pressure by certain members of Congress, as well as a lawsuit from one of the federal cultivation applicants, resulted in the August 2019 statement from the DEA with its latest excuse: that the Agricultural Improvement Act of 2018 (the Farm Bill) has thrown a monkey wrench into its study of the applicants and the cannabis research program. The DEA has stated that it is studying the implications of the Farm Bill and will make “adjustments to its policies and practices with respect to the marihuana growers program.” It further assured us that since 2016, the DEA has been engaged in an active policy review process of the program and, in fact, will be issuing proposed regulations “in the near future” that will supersede its 2016 policy statement.
Providing an additional glimmer of hope, on September 11, 2019, the DEA issued a press release indicating it is bumping up the size of the 2020 cannabis research crop by nearly 30% over the 2019 federal quota in order to meet with increased demand by DEA-registered cannabis researchers. Absent significant and continued political, legal and public pressure on the DEA or a change in federal law, however, there is little reason to believe that the DEA will take a meaningful change of course.
The United States has world-class medical research institutions and scientists, responsible for groundbreaking advancements in science and medicine. Yet we have reduced this mighty machine to a bush-league operation, thwarted at every turn by federal government agencies that have no stated interest in advancing the medicine of cannabis. The cannabis industry is held back from making any real gains in education and research by the same government institutions that continually caution there hasn’t been enough research done to substantiate medical claims regarding cannabis. It is an unacceptable Catch-22.
The United States has an opportunity to be a leader, but instead we are tripping over a mass of bureaucracy, historical discrimination and political motivations, none of which have anything to do with medical research. The danger of not studying cannabis produced by those who are most qualified is failing our society.
Can cannabis cure Alzheimer’s, shrink cancerous tumors and increase the efficacy of antibiotics?
We don’t know. But an army of U.S. researchers is ready and willing to find out.
The DEA must move beyond its broken marriage to Ole Miss and allow the U.S. to lead the study of cannabis and its therapeutic potential.
Kathryn Ashton is a partner at Dentons, a leader of the firm’s global health care group and co-chair of its cannabis group. She concentrates her practice in health care transactional matters with an emphasis on finance.