Why the DEA, not the FDA? Revisiting the Regulation of Potentially-Addictive Substances

22 Pages Posted: 3 Sep 2020 Last revised: 23 Sep 2020

Date Written: July 30, 2020

Abstract

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized the legislative intent of balancing the medical and scientific considerations with those of law enforcement, tilting the weight of determinations instead to law enforcement criteria and a criminal justice approach to its regulation and enforcement. The current shift in legislative preference for a health-oriented approach begs the question: Why continue to give such regulatory powers to the DEA and not a public health agency like the FDA?

While such transfer of regulatory powers may seem radical, it becomes less so after an analysis of some often-forgotten FDA history. For at least 20 years prior to the DEA’s creation, the FDA regulated and enforced the regulations of illicit sales of non-narcotic drugs, like barbiturates and amphetamines. In 1966, Congress formalized these enforcement powers by creating the Bureau of Drug Abuse Control (“BDAC”) within the FDA. However, the BDAC was transferred out of the FDA just two short years later. It was merged with the FBN and then moved to the DOJ. It later became the agency we now know as the DEA.

To some, the BDAC’s short-lived existence might suggest that Congress perceived the FDA’s enforcement efforts as a failure. Others may correctly point out that FDA Commissioners were eager to get rid of the BDAC when given the opportunity to do so. Why should Congress consider transferring exclusive powers to regulate controlled substances to the FDA, if previous FDA Commissioners lobbied to rid the agency of these powers decades ago?

Building a case for the transfer of regulatory powers from the DEA to the FDA is a subject worthy of a book-length manuscript, but an apt starting point is to gain a deeper understanding of how the DEA, instead of the FDA, ended up with the primary powers to regulate and enforce the regulations on potentially-addictive substances. While other scholars have described the circumstances surrounding this assignment of powers to the DEA, this article extends their research and makes new findings about the circumstances surrounding the transfer of the BDAC, and its power to regulate, to the DEA.

Using oral history testimonies from FDA investigators and administrative officials, this Article adds to the historic literature on the allocation of regulatory and enforcement powers over potentially-addictive substances. In doing so, this Article provides evidence in support of a contemporary transfer of regulatory power from the DEA to the FDA. The primary contribution of this Article is that it demonstrates that the removal of the BDAC from the FDA was not due to the BDAC’s poor performance or its more regulatory approach to enforcement, but rather in large part due to FBN infiltration into the BDAC and the corruption and criminal justice approach that accompanied the FBN influence.

Keywords: DEA, FDA, opioid, regulations

Suggested Citation

El-Sabawi, Taleed, Why the DEA, not the FDA? Revisiting the Regulation of Potentially-Addictive Substances (July 30, 2020). New York University Journal of Law and Business, Vol. 16, No. 2, 2020, Elon University Law Legal Studies Research Paper Forthcoming, Available at SSRN: https://ssrn.com/abstract=3664267 or http://dx.doi.org/10.2139/ssrn.3664267

Taleed El-Sabawi (Contact Author)

Elon University School of Law ( email )

201 N. Greene Street
Greensboro, NC 27401
United States
3362799371 (Phone)
27401 (Fax)

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