Pharmaceutical Federalism

56 Pages Posted: 20 Sep 2015 Last revised: 27 Jun 2017

Patricia J. Zettler

Georgia State University - College of Law

Date Written: September 15, 2015

Abstract

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends into medical practice regulation in some circumstances. It then begins to explore implications outside of the preemption context, arguing that state regulatory efforts may also help to inform our general understanding of both the scope of the FDA’s jurisdiction and the relationship between the FDA and the states.

Keywords: FDA, Drugs, Federalism, Public Health

Suggested Citation

Zettler, Patricia J., Pharmaceutical Federalism (September 15, 2015). Indiana Law Journal, Vol. 92, 2017; Georgia State University College of Law, Legal Studies Research Paper No. 2016-20. Available at SSRN: https://ssrn.com/abstract=2661462 or http://dx.doi.org/10.2139/ssrn.2661462

Patricia J. Zettler (Contact Author)

Georgia State University - College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

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