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.

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