State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products

55 Pages Posted: 19 Mar 2016 Last revised: 17 Aug 2016

See all articles by Lars Noah

Lars Noah

University of Florida Levin College of Law

Date Written: March 17, 2016

Abstract

Do individual states have the power to prohibit the sale and use of a drug that the U.S. Food and Drug Administration (FDA) has approved? Two years ago, the Commonwealth of Massachusetts tried to do so, but a federal court issued a preliminary injunction against this action. Although criticized at the time as unprecedented, the Massachusetts ban hardly represented the first time that a state had taken such an initiative, but it did provide the occasion for considering whether the U.S. Constitution would stand in the way. This Article carefully evaluates objections based on implied preemption under the Supremacy Clause, the dormant Commerce Clause doctrine, and the Due Process Clause of the Fourteenth Amendment. As it turns out, the question does not admit of a categorical answer, but at least in some circumstances a state would violate the Constitution if it tried to nullify a federal license granted to the manufacturer of a pharmaceutical product.

Keywords: FDA, states, licensing, pharmaceuticals, preemption, dormant commerce clause, substantive due process

JEL Classification: H77, I18, K32, L65

Suggested Citation

Noah, Lars, State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products (March 17, 2016). Michigan State Law Review, Vol. 2016, No. 1, University of Florida Levin College of Law Research Paper No. 16-24, Available at SSRN: https://ssrn.com/abstract=2749359

Lars Noah (Contact Author)

University of Florida Levin College of Law ( email )

P.O. Box 117625
Gainesville, FL 32611-7625
United States
352-273-0923 (Phone)
352-392-3005 (Fax)

HOME PAGE: http://www.law.ufl.edu/faculty/lars-noah

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