Food and Drug Law Commons^™

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 …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

"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 …

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 …

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

Contributions to Books

No abstract provided.

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 …

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 …

Regulating The Underground: Secret Supper Clubs, Pop-Up Restaurants And The Role O F Law, Sarah B. Schindler

Faculty Publications

Instagram pictures of elegantly plated dinners, long farmstyle tables, and well-to-do people laughing in what looks like a loft apartment are followed by commenters asking, “Where is this?” This is the world of underground dining. Aspiring and established chefs invite strangers into their homes (or their friends’ stores after hours, or the empty warehouse at the edge of town, or the nearest farm) for a night of food and revelry in exchange for cash. Although decidedly antiestablishment, these secret suppers and pop-up restaurants are popular—there are websites to help people locate them, and many respected publications have penned stories about …

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 …

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 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 …