Quitting Cold Turkey?: Federal Preemption Doctrine and State Bans on FDA-Approved Drugs

By Costello, Thomas A. | The William and Mary Bill of Rights Journal, March 2018 | Go to article overview

Quitting Cold Turkey?: Federal Preemption Doctrine and State Bans on FDA-Approved Drugs


Costello, Thomas A., The William and Mary Bill of Rights Journal


INTRODUCTION

For the past two decades, the United States has struggled to deal with a massive public health crisis stemming from the overprescription and abuse of opioids.1 Between legally prescribed analgesic pain medications, such as OxyContin®, and illegal drugs, such as heroin, over 29,000 Americans died because of an overdose in 2015.2 Americans have become increasingly dependent on pain medications, with "more than enough [opioid prescriptions] to give every American adult their own bottle of pills" in 2012.3 The prescription opioid industry is massive, with an approximate value of $8.34 billion in 2012.4

Given the vast size of this health epidemic, various efforts have been made by state and federal governments. For example, in 2016, the Center for Disease Control (CDC) announced new guidelines for prescribing opioid painkillers that focused on limiting their prescription ifpossible.5 Additionally, in 2016, Congress approved and President Obama signed the Comprehensive Addiction and Recovery Act, which largely focused on the symptoms of the epidemic-large numbers of opioid addicts- as opposed to going after the underlying issue.6 In 2014, the Commonwealth of Massachusetts attempted to tackle the opioid epidemic at what it perceived to be its source-the widespread availability of prescription opioids-by illegalizing an FDAapproved opioid before it went to market.7 Although other states have enacted restrictions on controversial FDA-approved drugs in the past,8 none have gone as far as to ban the drug outright.9

Although that particular drug has not become a street drug of choice as regulators feared,10 looking at Massachusetts's public health legislation and the resulting litigation11 provides a unique opportunity to examine the constitutionality of a state banning an FDA-approved drug without being preempted by federal law under the Supremacy Clause.12 Using the backdrop of this situation, this Note will review the case law regarding implied preemption and propose a return to a Wyeth v. Levine13 framework for preemption decisions with modifications specifically allowing a state to ban an FDA-approved drug in certain extremely limited conditions. Specifically, this framework would add a value calculation into federal preemption doctrine that would allow a court to factor in information discovered after a drug has been approved by the FDA and a state's immediate local concerns reflecting unique, exigent circumstances.

The Wyeth framework is superior to the current implied preemption framework, as represented by Mutual Pharmaceutical Co. v. Bartlett,14 as it grants states more leniency in crafting policy attuned to their needs. Such a modified framework would expand on those benefits by allowing rapid responses to urgent state needs that may not have been fully reflected in the FDA's approval process, thereby providing a method for states to force technological progress through economic incentive.

in order to create this modified framework, this Note will first examine the current case law surrounding implied federal preemption under the Supremacy Clause. Part I will discuss the opioid epidemic specifically in the Commonwealth of Massachusetts, as well as the legislation pursued by Governor Patrick and litigation that it prompted. Part II will examine three Supreme Court cases that all play a significant role in current preemption jurisprudence and directly relate to the Zogenix v. Patrick,15 litigation. After reviewing the case law, Part III will establish the modified framework and lay out the positives and negatives of allowing that amount of state freedom from preemption. Additionally, this Part will apply the modified framework to the Zogenix facts as an example of how a case might turn out under this framework. Finally, Part IV will use the recent immigration case of Arizona v. United States16 to demonstrate that this modification would not significantly hurt object preemption analysis outside the prescription drug context. …

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