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2016 Mich. St. L. Rev. 1 (2016)

handle is hein.journals/mslr2016 and id is 1 raw text is: STATE AFFRONTS TO FEDERAL PRIMACY IN THE LICENSURE OF PHARMACEUTICAL PRODUCTS Lars Noah* 2016 MICH. ST. L. REV. 1 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. TABLE OF CONTENTS INTRODUCTION.......................................... 2 I. STATE EFFORTS TO PROHIBIT WHAT THE FDA HAS ALLOWED ......................................... 3 A. Massachusetts Takes on Zohydro® (and Loses) ............... 3 B. Previous Attempts to Bar FDA-Approved Drugs ............. 16 II. ASSESSING THE CONSTITUTIONAL OBJECTIONS ...... ...... 27 A. Implied Preemption............................. 27 B. Dormant Commerce Clause ....................... 35 C. Substantive Due Process .................... ..... 42 CONCLUSION ......................................... 53 * Professor of Law, University of Florida.