Food and Drug Law Commons^™

Ending Drunk Driving With A Flash Of Light, Andrew Sullivan

Law Student Publications

Among the methods used to combat drunk driving is mandating a person convicted of driving under the influence/driving while intoxicated install an ignition interlock device (“IID”) in his/her vehicle as a condition of restoring his/her driving privileges.This comment argues that the National Highway Traffic Safety Administration (“NHTSA”) has the authority to issue such a regulation; it need only be presented with a workable opportunity to do so. The present state of IID technology is a poor candidate to make this hypothetical regulation workable, but advances in Near Infrared (“near-IR”) Spectroscopy will provide the technology necessary to make a discussion of …

"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching

Cardozo Journal of Conflict Resolution

This Note discusses the benefits that mediation can have on the reverse payment settlement and antitrust debate, and how it can satisfy the "rule of reason" requirement post-Actavis. Accordingly, Section II discusses the legislative history and policy of the Hatch-Waxman Act. It elaborates on the pioneer drug development process and how the combination of legislation and the inherent nature of drug development resulted in "pay-for-delay" settlements. Section III discusses majority and dissenting opinions in the landmark Supreme Court case FTC v. Actavis as well as the circuit split decisions that led up to the Court's ultimate ruling and …

The Fda And The Rise Of The Empowered Patient, Lewis Grossman

Contributions to Books

No abstract provided.

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane

Michigan Telecommunications & Technology Law Review

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …

Orthodoxy And 'The Other Man's Doxy': Medical Licensing And Medical Freedom In The Gilded Age, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

This is a draft of Chapter Two of my book-in-progress under contract with Oxford University Press titled You Can Choose Your Medicine: Freedom of Therapeutic Choice in American History and Law. This chapter shows how freedom of therapeutic choice remained an influential theme in American policy and thought in the Gilded Age. Despite the almost universal restoration of medical licensing after the Civil War, the new licensing regimes were drafted and enforced in ways that protected the rights of practitioners and patients of nonorthodox schools of medicine. This chapter starts by briefly describing the main alternative medical sects during the …

Tort As Democracy: Lessons From The Food Wars, Melissa Mortazavi

Faculty Articles

This Article develops alternative emerging theories regarding the function of tort in American civil society. Often, scholars and policymakers evaluate the tort system in terms of compensation, loss allocation, and risk management. This focus overlooks an important modern function of tort; in the context of the modern administrative state, tort is a vital player in the democratic deliberative process. Tort suits bring forth new ideas, force fact-finding, and increase communication amongst public and private institutional actors to develop sound and legitimate law and policy. Perhaps nowhere is this more obvious today than with the current boom of food litigation. Lawsuits …

Creating Order Amidst Food Eco-Label Chaos, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Eco-labels, certifications, and seals of approval serve a variety of functions including communicating to businesses and consumers the environmental attributes of a particular product and incentivizing improvements in production. Eco-labels also provide a basis for companies to set measurable sustainability goals for sourcing, improvements, and transparency. As they gain greater traction in the marketplace, however, there has been a massive proliferation of labels, certifications, and green seals of approval. This has led to consumer confusion, inaccurate and misleading claims, and inconsistent standards. A 2009 survey identified about 600 labels that denote some definition of “environmentally friendly” worldwide, including more than …

Cool Story: Country Of Origin Labeling And The First Amendment, Rebecca Tushnet

Georgetown Law Faculty Publications and Other Works

Country of origin labeling (COOL) requirements have long been part of government regulation of commerce. While one might ordinarily think of mandatory COOL as part of trade policy--or even as a means of encouraging individual citizens to engage in country-specific buying that would be disallowed as protectionism if carried out by their governments -- the most robust legal challenges to mandatory COOL now come from the First Amendment, not from free trade principles. This reliance on free speech claims offers a stark example of the charismatic force of the First Amendment. Objections having little to do with free speech at …

Why Healthy Behavior Is The Hard Choice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Our society is structured to encourage unhealthy diets and physically inactive lifestyles, which are key risk factors for chronic diseases including diabetes, heart diseases, and cancers. We are bombarded with advertisements for hyperprocessed foods laden with saturated fat, salt, sugar, and refined carbohydrates, “low-fat” foods often contain high amounts of sugar and salt, and parks and recreation spaces are often inaccessible or unsafe.

Four simple ideas - taxes on unhealthy products, product reformulation, improving the informational environment, and increasing healthy food accessibility - could make healthy behaviors the “default” choice for most consumers. First, taxes on unhealthy products, such as …

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

Vanderbilt Journal of Entertainment & Technology Law

Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

The Importance Of The Right To Food For Achieving Global Health, Emilie K. Aguirre

Faculty Scholarship

The Framework Convention on Global Health (FCGH) represents a significant opportunity to realize the right to health globally. However, in order to succeed the FCGH must be carefully considered: it must take a new evidence-based approach that departs meaningfully from past shortcomings in realizing the right to health. Central to this approach is recognizing, formally incorporating, and operationalizing the right to adequate food. This right should be correctly interpreted as a right to a standard of nutritional quality and not as a right to a minimum number of calories. Because nutrition is critical to the achievement and maintenance of good …

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

The Risks We Are Willing To Eat: Food Imports And Safety, Alexia Brunet Marks

Publications

Recent efforts to regulate the safety of U.S. food imports have not kept up with the complexity of global trade and the risks that accompany globalization. Congress drafted the Food Safety Modernization Act of 2011 ("FSMA") in response to heightened food safety risks, surging imports, and an outdated food import safety system. While the FSMA provides the Food and Drug Administration ("FDA") additional authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, and oversee imported foods, vulnerabilities still exist.

This article exposes problems with the old system of food import rules and significant challenges facing the …

Rethinking The Childhood-Adult Divide: Meeting The Mental Health Needs Of Emerging Adults, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

Part I of this article describes ADHD and explores the extent of ADHD medication abuse, especially among young adults. Part II discusses the characteristics of emerging adults, who may be more likely than their older counterparts to make unwise decisions about medications and other life choices.34 While we protect minors by requiring parental consent for their medical treatments, emerging adults are effectively able to obtain any drug on the market if they convince the doctor that they have the requisite diagnosis. Part III explores HIPAA, the medical malpractice standard of care and the challenges associated with a society that is …

New York City Rules! Regulatory Models For Environmental And Public Health, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Scholars have become increasingly interested in facilitating improvement in environmental and public health at the local level. Over the last few years, former New York City Mayor Michael Bloomberg and the New York City Council have proposed and adopted numerous environmental and public health initiatives, providing a useful case study for analyzing the development and success (or failure) of various regulatory tools, and offering larger lessons about regulation that can be extrapolated to other substantive areas. This Article, first, seeks to categorize and evaluate these “New York Rules,” creating a new taxonomy to understand different types of regulation. These “New …

Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.

Preventative V. Punitive: How Genetically Modified Rice Litigation Shaped Regulation And Remedy For Genetically Engineered Crops, Allison Waldrip Bragg

Journal of Food Law & Policy

As agricultural technology develops, new issues emerge. While genetically engineered crops can increase yields and productivity, they can also increase new legal concerns that had not previously existed. One such concern is the comingling of non-engineered crops with genetically engineered varieties. The corruption of plants that are not engineered is a problem not only because of the loss of that original plant itself if the entire plant population were to become comingled, but also because of the inability to sell a crop that has been intended as a non-engineered crop when it is infiltrated by genetically engineered material.