“That’s a Lot of Marijuana”

By Nadia N. Sawicki

Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research.

The current approval process for clinical research of the effects of marijuana differs significantly from traditional research approval processes. If funded by the NIH, proposals to research marijuana must undergo traditional peer review; however, non-NIH-funded proposals must first be reviewed by a scientific review panel within the Department of Health and Human Services (an unusual step). Researchers must then submit an Investigational New Drug Application with the FDA and obtain DEA registration, as would be the case for any research on controlled substances. And finally, researchers must seek approval from NIDA in order to obtain a supply of research-grade marijuana. NIDA, a part of the NIH, is the sole entity responsible for overseeing the cultivation and distribution of all legal marijuana in the U.S., which is grown at the University of Mississippi.

NIDA has been widely criticized in recent years for not being receptive enough to research on marijuana and other Schedule I drugs. Researchers whose HHS-approved proposals have been denied by NIDA allege that NIDA has only been willing to approve research that studies the risks, not the benefits, of illegal drugs.

But perhaps these criticisms are about to change. This year, NIDA updated its website to clarify that it does indeed approve studies on the therapeutic benefits of marijuana. NITA identified 28 active grants that it has funded in the past few years to study marijuana’s effects on autoimmune disease, inflammation, pain, psychiatric disorder, seizures, and drug dependence; as well as a number of independently funded studies that received NIDA’s approval to obtain research-grade marijuana. It is in response to these approved studies that the DEA approved NITA’s request to dramatically increase the marijuana production quota.

If this trend continues, then perhaps the United States will finally be able to achieve the goals set out fifteen years ago in the Institute of Medicine’s 1999 report, Marijuana and Medicine: Assessment of the Science Base, which strongly recommended that clinical trials be conducted to study the medicinal effects of cannabinoid drugs.

Cross-posted at Health Law Prof Blog.

Nadia Sawicki

Nadia N. Sawicki is a Georgia Reithal Professor of Law at Loyola University Chicago, and Academic Director of Loyola’s Beazley Institute for Health Law and Policy. Her research focuses on patient decision-making and the informed consent process, particularly in the areas of end-of-life and reproductive care. Her work has been published in a variety of peer-reviewed journals - including the New England Journal of Medicine; Law & Policy; the Journal of Law, Medicine & Ethics; the American Medical Association Journal of Ethics; the Journal of Clinical Ethics; the American Journal of Bioethics; and the Journal of Legal Medicine – as well as in many academic legal journals. She has previously served as a member of the American Bar Association’s Special Committee on Bioethics and the Law, and was the co-chair of the American Society for Bioethics and the Humanities’ Law Affinity Group. Prof. Sawicki received her J.D. from University of Pennsylvania Law School, and her Masters in Bioethics from University of Pennsylvania School of Medicine. She is a graduate of Brown University, with a concentration in biomedical ethics. Prior to joining the Loyola faculty, Prof. Sawicki held the inaugural George Sharswood Fellowship at the University of Pennsylvania Law School, served as a lecturer in History and Sociology of Science at the University of Pennsylvania's School of Arts and Sciences, practiced law with Wolf, Block, Schorr & Solis-Cohen, and clerked for the Honorable J. Curtis Joyner of the U.S. District Court for the Eastern District of Pennsylvania.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.