Food and Drug Law Commons^™

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 …

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 …

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 …

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 …

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 …