Food and Drug Law Commons^™

Has The Supreme Court Incorrectly Expanded § 271(E)(1) To Risk A Regulatory Taking?, 5 J. Marshall Rev. Intell. Prop. L. 216 (2006), Tara Stuart

UIC Review of Intellectual Property Law

The U.S.S.C. expanded the scope of the Hatch-Waxman Act’s safe harbor provision in Merck III to include protection for infringing use of any type of invention as long as a researcher intended to perform research reasonably relevant to FDA approval. This broad interpretation is inconsistent with the legislative intent of the Hatch-Waxman Act, and the policies of the U.S. patent system. Many patent owners may unnecessarily experience such a reduction in their property rights as to constitute a regulatory taking. The proposed narrow interpretation would rectify the constitutional problems and inconsistencies in infringement exemptions. Section 271(e)(1) should apply only to …

Suppression Of Innovation Or Collaborative Efficiencies?: An Antitrust Analysis Of A Research & Development Collaboration That Led To The Shelving Of A Promising Drug, 5 J. Marshall Rev. Intell. Prop. L. 348 (2006), Saami Zain

UIC Review of Intellectual Property Law

This article discusses antitrust issues present in research and development collaborations between competitors. In particular, it illustrates that, although often very beneficial, these collaborations may have the potential for considerable harm via suppression of innovation. The article examines a recent case involving a collaboration to develop drugs, which arguably resulted in the suppression of a promising drug.

Chemical Taking: Glyphosate And The Eradication Of Due Process In Colombia, David A. Wilhite

Sustainable Development Law & Policy

No abstract provided.

Need For Cognition And Message Complexity In Motivating Fruit And Vegetable Intake Among Callers To The Cancer Information Service, Pamela Williams-Piehota, Judith Pizarro, Stephanie A. Navarro Silvera, Linda Mowad, Peter Salovey

Department of Public Health Scholarship and Creative Works

This field experiment examined the impact of an individual's need for cognition (NFC; the tendency to enjoy thinking deeply about issues), complex versus simple messages, and the interaction of NFC and message type on encouraging fruit and vegetable consumption. Callers to the Cancer Information Service of the National Cancer Institute (N = 517) were asked to participate in the experiment at the end of their call. Individual NFC was assessed, and participants were assigned randomly to receive a telephone message promoting fruit and vegetable consumption that was either complex and multifaceted or simple and straightforward. Similarly constructed brochures were mailed …

Paying For Delay: Pharmaceutical Patent Settlement As A Regulatory Design Problem, C. Scott Hemphill

Center for Contract and Economic Organization

Over the past decade, drug makers have settled patent litigation by making large payments to potential rivals who, in turn, abandon suits that (if successful) would increase competition. Because such "pay-for-delay" settlements postpone the possibility of competitive entry, they have attracted the attention of antitrust enforcement authorities, courts, and commentators. Pay-for-delay settlements not only constitute a problem of immense practical importance in antitrust enforcement, but also pose a general dilemma about the proper balance between innovation and consumer access.

This Article examines the pay-for-delay dilemma as a problem in regulatory design. A full analysis of the relevant industry-specific regulatory statute, …

The Right To Food: Holding Global Actors Accountable Under International Law, Smita Narula

Elisabeth Haub School of Law Faculty Publications

Economic globalization represents both an unmet opportunity and a significant challenge for the fulfillment of social and economic rights, including the right to food. While corporate sector accountability and the responsibility of international financial institutions (IFIs) to ensure social and economic rights are now at the forefront of the globalization discourse, greater attention must be paid to how these actors can be held accountable under international law. The existing human rights legal framework is ill-equipped to deal with violations committed by non-state actors, such as transnational corporations (TNCs), and multi-state actors, such as IFIs. Using the right to food as …

A New Disease Born Every Minute: The Marketing Of Pathology And The Exploitation Of Gender-Based Insecurities And Sexuality To Sell Drugs, Elizabeth Lambdin

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion

Public Interest Law Reporter

No abstract provided.

Bioshield 2: A Shot In The Right Direction?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman

Faculty Works

The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.

This article begins in Section II with an …

Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah

Faculty Scholarship

The Author reviews Michele Goodwin’s book BLACK MARKETS: THE SUPPLY AND DEMAND OF BODY PARTS, published by Cambridge University Press, 2006. The book discusses the shortage of cadaveric organs available for transplantation. It argues that the shortage disproportionately impacts racial minorities. It then analyzes existing organ procurement laws and proposed alternatives, with a focus on market solutions.

BLACK MARKETS is impeccably researched and persuasively argued, though some of its points are certainly controversial. The book is aimed at and very accessible to a general audience, but it will also prove interesting and informative to legal, medical and public health academic …

A Growing Controversy: Genetic Engineering In Agriculture, Holly Beth Frompovicz

Villanova Environmental Law Journal (1991 - )

No abstract provided.

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Merck V. Integra And Its Aftermath: A Safe Harbor For The Commercial Use Of Biotechnology Research Tools?, Brendan M. O'Malley

Cardozo Arts & Entertainment Law Journal

No abstract provided.

History Turned "Sideways": Granholm V. Heald And The Twenty-First Amendment, Harris Danow

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Scientific Secrecy And "Spin": The Sad, Sleazy Saga Of The Trials Of Remune, Susan Haack

Articles

No abstract provided.

Labeling Genetically Modified Food: Comparative Law Studies From Consumer's Perspective, Christopher C. H. Chen

Research Collection Yong Pung How School Of Law

This article focus on the genetically modified food and labelling requirement. The relatively new technology raises some concerns over the safety of food containing genetically modified substance. The "substantial equivalent" doctrine, adopted by the U.S., and the "precautionary" doctrine, taken by the EU, represent two contradictory approaches to reconcile new biotechnology and consumer protection, a difference influenced by politics or food industry rather than by consumer attitudes. In this article, we argue that consumers cannot make their own choices and exercise market power without a certain degree of disclosure of information. However, even though food labelling is an effective way …

An Environmental Pool For The Rio Grande, Kara Gillon

Publications

The Bureau of Reclamation and Corps of Engineers operate a series of dams, reservoirs, and levees along the Middle Rio Grande of New Mexico. The plight of the Rio Grande silvery minnow, an endangered species, and of the river itself demonstrates the need for a change from the emphasis on water development to sustainable river management. Conservation groups invoked the protections of the Endangered Species Act to catalyze this change. Recognizing that flexibility is necessary to meeting competing water needs, the groups also promoted the need for and several approaches to a sustainable and long-term approach to river management and …

From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel

ExpressO

John Stuart Mill’s harm principle maintains that adult behavior cannot justifiably be subject to social coercion unless the behavior involves harm or a significant risk of harm to non-consenting others. The absence of harms to others, however, is one of the distinguishing features of many manifestations of “vices” such as the consumption of alcohol, nicotine, recreational drugs, prostitution, pornography, and gambling. It is with respect to vice policy, then, that the harm principle tends to be most constraining, and some current vice controls, such as prohibitions on drug possession and prostitution, violate Mill’s precept. In the vice arena, we seem …

Medicaid Third-Party Liability And Claims For Restitution: Defining The Proper Role For The Tort System In Regulating The Food Industry, Coby Warren Logan

Journal of Food Law & Policy

This comment contends that tort liability can complement legislative and administrative government regulation of the food industry, providing sellers and manufacturers of food with an incentive to prevent consumers from over-consumption and becoming obese. Specifically, this comment supports the proposition that after government regulations are promulgated by Congress, claims should be allowed by state attorneys general to recoup Medicaid costs incurred in treating health conditions and illnesses caused by obesity.

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

Update on European Union Food Law 2005.

From The Farm To The Factory: An Overview Of The American And European Approaches To Regulation Of The Beef Industry, Crisarla S. Houston

Journal of Food Law & Policy

First, this article briefly describes the existing regulatory requirements under both systems. Second, it compares the two approaches. In comparing the two systems, attention is concentrated on the quality of legislative drafting, the likelihood of implementation, the adequacy of consumer protection, the voluntary or compulsory nature of the measures, and the requirement of records retention.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

United States Food Law Update, Michael Tingey Roberts

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law over the first half of 2005. Not every change in national food law for the first half of 2005 is included; instead, this update is limited to significant changes in national law. New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update. These updates provide a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modem society. Tracing the development of food law through these updates also builds an important historical context …

The Food Safety And Inspection Service's Lack Of Statutory Authority To Suspend Inspection For Failure To Comply With Haccp Regulations, Dennis R. Johnson, Jolyda O. Swaim

Journal of Food Law & Policy

Since the implementation of the Mega-Reg, the agency has had mixed success with its new enforcement procedures. Although most establishments have chosen to work with FSIS to modify their procedures to allay any concerns the agency had, on a few occasions, no compromise was reached. In these cases, the establishment filed suit in federal district court challenging the agency's authority to remove inspectors for failure to comply with the Mega-Reg. In the three cases where the agency's authority was challenged, the establishment was successful and inspection was restored.

Preempting Food Safety: An Examination Of Usda Rulemaking And Its E.Coli O157:H7 Policy In Light Of Estate Of Kriefall Ex Rel. Kriefall V. Excel Corporation, Denis Stearns

Journal of Food Law & Policy

This article will use the Kriefall decision to examine USDA rulemaking and its still-evolving E. coli 0157:H7 policy. Part II of the article will briefly describe the development and implementation of the USDA E. coli 0157:H7 policy as a reaction to an enormous and widely-publicized outbreak of E. coli infections that occurred in 1993-the so-called Jack in the Box outbreak. Following the outbreak, E. coli 0157:H7 was declared by USDA to be an adulterant per se according to FMIA. It was also at this time that the first steps were taken by USDA to move from a "command and control" …

Journal Of Food Law & Polic - Fall 2005, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

A Mathematical Approach To Benefit-Detriment Analysis As A Solution To Compulsory Licensing Of Pharmaceuticals Under The Trips Agreement, Vishal Gupta

Cardozo Journal of International and Comparative Law

The note proposes a mathematical approach to benefit-detriment analysis as a solution to the challenges posed by compulsory licensing of pharmaceuticals under the TRIPS Agreement. The core argument is that a socio-economic framework, comparing the monetary detriment to pharmaceutical companies (D) with the aggregate societal benefit (H x C), where H is the average health benefit per person and C is the number of affected citizens, can provide a balanced and objective method to determine when compulsory licenses should be granted. This approach aims to address the "Paragraph 6 problem" and improve access to essential medicines in developing countries while …