State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products
Michigan State Law Review, Vol. 2016, No. 1
University of Florida Levin College of Law Research Paper No. 16-24
55 Pages Posted: 19 Mar 2016 Last revised: 17 Aug 2016
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: Suggested Citation