Law Commons^™

New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson

Faculty Scholarship

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Keeping Up With New Legal Titles, Franklin L. Runge

Law Faculty Scholarly Articles

In this book review, Franklin L. Runge discusses In Food We Trust: The Politics of Purity in American Food Regulation by Courtney I. P. Thomas.

Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black

Law Faculty Scholarship

The headlines on any given day claim that the American "obesity epidemic" continues to worsen.' According to these headlines, Americans, both adults and children, are increasingly becoming more obese, are more likely to be diagnosed with diabetes, and will likely prematurely die due to this preventable disease. Numerous private industries, as well as the government, seek to rescue Americans from this crisis. As the obesity epidemic debate intensifies, the call for more government regulation correspondingly grows. There are critics, however, who question the legitimacy of this epidemic and the need for more regulation. For example, some well-known scholars opine that …

Scale Economies, Scale Externalities: Hog Farming And The Changing American Agricultural Industry, Shi-Ling Hsu

Scholarly Publications

American agriculture is inexorably concentrating into the hands of a small number of large conglomerates. Expanding farms pursuing scale economies would normally have to abide by a system of environmental and other laws that would, in theory, require farms to account for negative externalities. If those laws were observed and enforced, they would help strike a balance between the greater profitability and the larger externalities of scaling up. But these laws are not widely observed nor rigorously enforced, which upsets this balance and gives large-scale farms a cost advantage while insulating them from corresponding responsibilities.

Perhaps nowhere in agriculture is …

Agency Publicity In The Internet Era, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Report, prepared for the Administrative Conference of the United States (ACUS), details how federal agencies use modern forms of publicity - including press releases, agency web sites, searchable online databases, and social media - to achieve regulatory ends. It evaluates the benefits and burdens of modern agency publicity practices, using three agencies as case studies: the Food and Drug Administration (FDA); the Federal Trade Commission (FTC); and the Consumer Financial Protection Bureau (CFPB). Part V recommends a series of largely procedural reforms that balance the need for public disclosure with the need to protect those potentially injured by adverse …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

Administrating Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as "gatekeepers" to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation.

Understanding administrative agencies' functions in managing or directing, i.e., "administrating," patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems …

Administering Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of government — Congress, the President, and the federal courts — save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as “gatekeepers” to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation. Understanding administrative agencies’ functions in managing or directing, i.e., “administrating,” patent litigation sheds both descriptive and normative insight on several aspects of patent reform. …