Food and Drug Law Commons^™

Examining The § 271(E)(1) Safe Harbor Of The Hatch-Waxman Act: A Legislative Proposal Granting Mandatory Post-Marketing Exceptions, Jessica Chao

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation, Michael S. Beck

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Rebalancing Pay-For-Delay: Why No-Authorized Generic Agreements Should Be Subject To Higher Antitrust Scrutiny, David C. Kurlander

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Sugary Drinks, Happy Meals, Social Norms, And The Law, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

What role should government play in discouraging harmful overconsumption? What modes of government intervention best strike the balance between effectiveness and political acceptability? It is well established that government has a legitimate interest in protecting the health and safety of the people, even from their own choices and actions. Furthermore, there is no fundamental right to sell or purchase particular services or products in particular configurations. The appropriate question, then, is not what government may do to prevent non- communicable diseases that are associated with individual behavior choices, but rather what government should do. This comment on David Friedman's Public …

The Farmer In Chief: Obama's Local Food Legacy, Sarah J. Morath

Akron Law Faculty Publications

As criticism over America’s food policy has grown, many scholars have offered suggestions for reform. Complementing this body of scholarship, The Farmer In Chief identifies and assesses recent changes to federal laws and policies as they affect ‘local food’ and describes local farmers’ awareness of and reaction to these changes. These changes and the farmers’ responses show greater recognition of local food by the President and federal government in three ways: increased inclusion of local food in legislation and policy discussions; increased awareness of the benefits of local food production and consumption; and increased consumer access to local food. But …

A Continuing Plague: Faceless Transactions And The Coincident Rise Of Food Adulteration And Legal Regulation Of Quality, Denis Stearns

Faculty Articles

Over two decades ago, the Jack in the Box E. coli outbreak, in which five victims died, and hundreds more were seriously injured, dramatically changed the way the world looked at food and food safety. Although deemed “trivial” by tort scholars, who nonetheless used legal doctrines first developed in food cases to justify the extension of strict liability to all products, this article uses the Jack in the Box outbreak as a point of departure for exploring not only the relationship between food, being, and knowledge, but to posit that commerce in food, and the inevitability of profit-motivated food adulteration, …

Ignorance, Harm, And The Regulation Of Performance-Enhancing Substances, Lisa Milot

Scholarly Works

There is a disconnect between how legal and sporting authorities, on the one hand, and many elite athletes, on the other, view the use of performance-enhancing substances. While official and popular narratives portray the use of these substances as isolated examples of deviant behavior, to the elite athletes who daily push their bodies beyond societally normal limits of pain and risk, enhancement is oftentimes an accepted part of the job. As a result, efforts to regulate and detect athletes’ use of these substances have consistently captured only a small fraction of the use that exists.

This Article describes the ways …

Prosser’S Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort’S Empire, Denis Stearns

Faculty Articles

In this article, Professor Stearns discusses the legal history of the development of the rules that govern liability for selling unsafe food.

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer

Cardozo Journal of Equal Rights & Social Justice

The article argues that the exclusion of pregnant women from clinical research constitutes sex discrimination. This exclusion, rooted in historical and regulatory factors, has led to a significant lack of data on how medications affect pregnant women, putting their health at risk. The author advocates for legislative action to shift the research culture from exclusion to inclusion, ensuring that pregnant women receive necessary medical treatments with proper research backing.

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …