Food and Drug Law Commons^™

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health …

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

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.

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 …

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, …

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.

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

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.

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 …

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 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 …

The Penumbra Of The United States’
 Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And 
Implications For The Pharmaceutical
 Industry, Beverley Earle, Anita Cava

Richmond Journal of Global Law & Business

No abstract provided.

The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox

Vanderbilt Journal of Transnational Law

The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …

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 …

Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment, Melina Harm Benson, Dagmar Llewellyn, Ryan Morrison, Mark Stone

Publications

No abstract provided.

Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico, Sharon Wirth

Publications

Freshwater ecosystems need adequate streamflow to supply clean water for humans and maintain healthy habitat for wildlife. Over-appropriation, overuse, climate change, and drought plague New Mexico's rivers, taxing many rivers beyond sustainability. Despite the myriad of problems caused by little or no water in our rivers, policies and procedures to protect and increase streamflows in New Mexico are limited. While most Western states have made demonstrable progress in alleviating various legal and technical barriers to protecting and increasing streamflows, New Mexico has made only limited, recent progress towards solutions for our drying rivers. This article takes a critical look at …

Food Choice: Should The Government Be At The Head Of The Table?, Emily Semands

Oklahoma Law Review

No abstract provided.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.