Pharmaceutical Federalism

Citation data:

92 Indiana Law Journal 845 (2017), Vol: 92, Issue: 3

Publication Year:
Usage 288
Downloads 156
Abstract Views 132
Repository URL:;
Zettler, Patricia J
Digital Repository @ Maurer Law
Pharmaceuticals; Drugs; Prescriptions; Federalism; Food and Drug Law; Law
article description
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.