Food and Drug Law Commons^™

Caveat Venditor: Products Liability And Genetically Modified Foods, Kristopher A. Isham

Journal of Food Law & Policy

Genetically modified organisms (GMOs) have become a lightning rod for conflict between farmers, corporations, shareholders, government agencies, and other concerned groups. Supporters tout GMOs as a solution to the problems of diminishing returns from traditional crop plants and the rising demand for greater quantities of food. Opponents criticize GMOs for potential toxic and allergic reactions in humans, loss of biodiversity, and pesticide and antibiotic resistance in other plants and insects. As the understanding of potential applications of biotechnology broadens, the risks and benefits of such products are being scrutinized more closely.

Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis

ExpressO

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In …

Rights, Rules, And Raich, Alex Kreit

West Virginia Law Review

No abstract provided.

Regulating Food Advertisements: Some First Amendment Issues, John M. A. Dipippa

University of Arkansas at Little Rock Law Review

No abstract provided.

A Taxonomy Of Obesity Litigation, Theodore H. Frank

University of Arkansas at Little Rock Law Review

No abstract provided.

Setting The Stage For Public Health: The Role Of Litigation In Controlling Obesity, Jason A. Smith

University of Arkansas at Little Rock Law Review

No abstract provided.

The Use Of Hair Analysis To Test Children For Exposure To Methamphetamine, Michael T. Flannery, Jerry Jones, Karen Farst, Karen Bord Worley

Law Faculty Scholarship

No abstract provided.

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Merck V. Integra: Bailing Water Without Plugging The Hole, Benjamin G. Jackson

Brigham Young University Journal of Public Law

No abstract provided.

Getting It Right By Getting It Wrong: How The Supreme Court Helped Healthcare Reform By Incorrectly Applying The Standard Of Review In Pharmaceutical Research And Manufacturers Of America V. Walsh, Brian Y. Furuya

Brigham Young University Journal of Public Law

No abstract provided.

Prescription Contraceptives And The Pharmacist's Right To Refuse: Examining The Efficacy Of Conscience Laws, Dennis Rambaud

Cardozo Public Law, Policy & Ethics Journal

The note examines the ethical and legal implications of pharmacists refusing to fill prescriptions for contraceptives based on moral or religious objections. It argues that existing legal protections under Title VII of the Civil Rights Act and professional standards already provide adequate safeguards for pharmacists, rendering additional conscience laws unnecessary. The analysis emphasizes the need to balance pharmacists' rights with patients' access to essential medications, highlighting concerns that conscience laws may hinder patient care without ensuring referrals to alternative providers.

Volume 6 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

Safeguarding Organic Food: The Need For International Certification Standards, Balse Kornacki

Sustainable Development Law & Policy

No abstract provided.

Conference Highlight - Panel: From Inmate To Legal Advocate , Kemba Smith

The Modern American

No abstract provided.

Conference Highlight-Northstar Award: Spotlight On Angela Davis , Jamin Raskin, Cynthia Jones

The Modern American

No abstract provided.

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 …

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.

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

Cardozo Arts & Entertainment Law Journal

No abstract provided.

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

Sustainable Development Law & Policy

No abstract provided.

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

Articles

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 …

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. …

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, …

Conscience And Emergency Contraception, Leslie C. Griffin

Scholarly Works

No abstract provided.

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 …