If There’s No Such Thing as Medical Marijuana, How Do We Have Medical Marijuana?

by Sam Halabi — Friday, Aug. 12, 2016

This week, the Drug Enforcement Agency (DEA) responded to petitions requesting a redesignation of marijuana for the benefit of scientific research. The DEA refused, citing, somewhat tautologically, the fact that there are no scientifically valid and well-controlled clinical trials demonstrating benefits for certain modalities of marijuana for specific medical indications.  DEA affirmed marijuana’s continued status as an illicit schedule I controlled substance.

If no such studies exist, why are states moving in the opposite direction on medical uses for marijuana? The answer is that a lower threshold of evidence has moved state legislatures (25 plus the District of Columbia) to tolerate medical uses for marijuana (to significantly varying degrees).  But that evidence is largely self-reports of how marijuana relieved pain, chemotherapy induced nausea and vomiting or HIV-AIDS Wasting Syndrome.  This is why the FDA “has not approved marijuana as a safe and effective drug for any indication” and the AMA “calls for further adequate and well-controlled studies of marijuana and related cannabinoids in patients who have serious conditions for which preclinical, anecdotal, or controlled evidence suggests possible efficacy.”

In the less heralded part of media coverage of the DEA decision, DEA also announced a policy change that could increase the number of authorized marijuana cultivators for research, a step in the direction of positions DEA and FDA have long held.

The bigger mess, begging for stronger Congressional action, is the shadow regulation of state-approved medical marijuana participants. While marijuana cultivation and distribution remains illegal under federal law, an October 2009 memo from Deputy Attorney General David Ogden to United States Attorneys stated that while “[t]he prosecution of significant traffickers of illegal drugs, including marijuana, . . . continues to be a core priority . . . , pursuit of these priorities should not focus federal resources in your states on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana.”  Congress adopted Section 538 of the Consolidated and Further Continuing Appropriations Act of2015, Pub. L. 113-235, 128 Stat. 2130 (2014) C’2015 Appropriations Act”),  which prohibited the Department of Justice from expending any funds in connection with the enforcement of any law that interferes with states’ ability to ‘”implement [their] own [laws] that authorize the use, distribution, possession, or cultivation of medical marijuana.”

Yet the Obama administration has not read the law to comprehensively prohibit action against actors in the medical marijuana supply chain, especially suppliers.

The result is an awkward merry-go-round between Congress, federal agencies with sometimes competing public health and law enforcement mandates, and states which, given the diversity in their medical marijuana laws, cannot be regarded as uniform in how they shape the nation’s marijuana laws.

Cite As: Author Name, Title, 36 Yale J. on Reg.: Notice & Comment (date), URL.

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About Sam Halabi

Professor Halabi is a scholar of national and global health law with a specialization in health services, pharmaceutical and agrifood business organizations. He serves as a Scholar at the O'Neill Institute for National and Global Health Law at Georgetown University, where he has also served as a special advisor to the Lancet-Georgetown University Commission on Global Health and Law. His work is published in the American Journal of Law and Medicine, the Harvard International Law Journal, the Journal of Law, Medicine, and Ethics, the Lancet, and the Journal of the American Medical Association (JAMA). He has also published volumes on pharmaceutical regulation and global management of infectious disease with Oxford University Press and Elsevier Academic Press. Before earning his J.D. from Harvard Law School, Professor Halabi was awarded a British Marshall scholarship to study in the United Kingdom where he earned an M.Phil in International Relations from the University of Oxford (St. Antony’s College). During the 2003-04 academic year, he served as a Rotary International Ambassadorial Scholar at the American University of Beirut.

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