Food and Drug Law Commons^™

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 …

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, …

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

Nevada Law Journal

No abstract provided.

United States--Certain Measures Affecting Imports Of Poultry From China: The Fascinating Case That Wasn't, Donald H. Regan

Articles

US–Poultry (China) was the first Panel decision dealing with an origin-specific SPS measure, or with what the United States referred to as an ‘equivalence regime’. More specifically, it was the first instance in which the basis for the challenged measure was the claimed inability of the complainant country to enforce its own food-safety rules. Unfortunately, as the litigation developed, the very interesting novel issues raised by such a measure were not discussed. This essay discusses those novel issues – in particular, what sort of scientific justification or risk assessment should be required for a measure like this, and what SPS …

One Size Does Not Fit All, David Spratt

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Introduction, Justin Hughes

Cardozo Arts & Entertainment Law Journal

No abstract provided.

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 …

Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel

Student Works

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.

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 …