Food and Drug Law Commons^™

Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher

Nevada Law Journal

No abstract provided.

Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness

Journal of Law and Health

This Article examines—and ultimately rejects—this anti-paternalism argument against government anti-obesity policies. It argues that government intervention in the food industry for the purpose of stemming the American obesity epidemic is justified and survives paternalistic objections to the contrary. This Article begins by briefly outlining the nature, severity, and causes of the obesity epidemic. It considers what can be done about the problem, finding that only government intervention is capable of effectively combating the crisis. It also outlines several types of potentially successful government anti-obesity strategies. Finally, it considers the primary topic of this Article: whether government anti-obesity policies constitute unjustified …

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to …

The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon

Kentucky Law Journal

No abstract provided.

The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow

Other Publications

The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.

Introduction, Justin Hughes

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Faculty Scholarship

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …

One Size Does Not Fit All, David Spratt

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Use Patents, Carve-Outs, And Incentives — A New Battle In The Drug-Patent Wars, Arti K. Rai

Faculty Scholarship

The Hatch-Waxman Act of 1984 aims to strike a balance between the innovation incentives provided by patents and the greater consumer access provided by low-cost generic drugs. The legislation, which relies in part on an explicit link between the FDA drug approval process and the U.S. patent system, has been controversial, particularly because of the ways in which firms producing brand-name drugs have exploited that link to delay market entry of generics as long as possible. Voluminous scholarship has focused on so-called "pay-for-delay" settlements of patent litigation between brand name and generic firms.

In contrast, this Perspective uses the lens …

Toward A Constructive Engagement: Agricultural Biotechnology As A Public Health Incentive In Less-Developed Countries, Chidi Oguamanam

Journal of Food Law & Policy

Discourses on global public health crises, especially as they impact the less-developed world, focus mostly on the issue of access to life-saving drugs for needy populations. Also, they implicate the misalignment of global pharmaceutical research and development (R&D) agenda with the health needs of the poor. Equally attracting significant attention is the role of intellectual property in driving up the cost of drugs and exacerbating the drug access freeze to needy populations. More often, the conceptual strings of these discussions are woven around a complex interaction of themes, including those of globalization, the development narrative, and strategic changes in international …

Legitimate Exercises Of The Police Power Or Compensable Takings: Courts May Recognize Private Property Rights, Terence J. Centner

Journal of Food Law & Policy

Under their police power, governments regulate nuisances and take actions in emergency situations. For protecting humans, animals, and plants from diseases and other pests (jointly referred to as diseases), governments order inoculations, quarantine items and people, and seize and destroy property.' With respect to plants and animals, the United States Secretary of Agriculture is authorized to prohibit the importation and movement of items than may be infested. The Secretary also has the authority to hold, treat, and destroy items to prevent the dissemination of plant and animal pests. State governments take additional actions to prevent the introduction and dissemination of …

Current And Emerging Issues In The New Urban Agriculture: A Case Study, Kathryn A. Peters

Journal of Food Law & Policy

Urban agriculture takes many forms, including individual gardens on privately owned land, neighborhood gardens, community gardens, and gardens located on church and school grounds, housing developments, and other publicly owned property. The most essential factors for successful urban agriculture efforts include land acquisition, zoning ordinances, access to affordable water, infrastructure, and support services such as education and outreach. Cities across the United States have formed task forces with the mission of making their cities more sustainable or strengthening the local food supply system; urban agriculture is instrumental in both of these missions. Major cities across the United States are recognizing …

The Tragedy Of The Horse, American Icon, Tim Opitz

Journal of Food Law & Policy

Whether a prohibition on slaughter improves the welfare of the American horse population is the focus of this article. At the time it was written, winter of 2010-2011, a confluence of Federal and State legislative action had ended domestic slaughter. These actions are detailed in the body of this article. Since 2007, the legal status of horse slaughter remained static. Just as Sir Isaac Newton's first law of motion explained, an object at rest tends to stay at rest. Legislative inertia is the perspective from which this article was originally written. However, Newton's first law also stated that the object …

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …

Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González

University of Miami Inter-American Law Review

No abstract provided.

Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck

Law Faculty Scholarship

In response to concerns over rising obesity rates, state and federal policymakers have introduced laws that seek to internalize the public health costs of consuming unhealthy foods. These laws range from taxes on sugared beverages to mandatory nutritional information disclosures and beyond. Vocal opponents to such laws, including many Tea Party members, characterize such laws as government overreaching into the private sphere. That opposition often evokes Revolutionary images and ideology, with references to the Boston Tea Party, the Founding Fathers, and the framing of the Constitution. This article challenges the symbolism used by these opponents by examining the pre-Revolutionary non-importation …

Breaking Free From Insanity: A White-Collar Crime Approach To Drug War Policy, Brian Harrison

University of the District of Columbia Law Review

Preventing crime should be a top priority for law enforcement. A victim of crime would readily agree that never having been a victim at all is preferable to suffering at the hands of a criminal. Even if the criminal is later caught and punished, a victim remains a victim. Despite this simple truth, current drug policy does not place a top priority preventing the laundering of drug-tainted money. As a result, the United States remains a victim in the War on Drugs.' As will be discussed, the crime of money laundering can be prevented in many instances by prosecuting banks …

What Would It Look Like If We Cared About Narcotics Trafficking? An Argument To Attack Narcotics Capital Rather Than Labor, Mark Osler

University of the District of Columbia Law Review

Law enforcement actions should be judged by a simple measure: are they solving a problem? After all, we Americans loathe the loss of freedom and the spending of tax dollars, and we should never take away citizens' freedom and money unless there actually is a problem being solved. Illegal narcotics are a problem, but we aren't solving it. Narcotics trafficking and use lead to violence, undermine productivity,' and rip apart the social fabric of families and communities. Despite much attention to these issues, drug use in this country continues at high levels, even among children.2 We have failed, and it …

Again And Again We Suffer: The Poor And The Endurance Of The "War On Drugs", Brian Gilmore

University of the District of Columbia Law Review

No abstract provided.