Open Access. Powered by Scholars. Published by Universities.®

Food and Drug Law Commons™

Open Access. Powered by Scholars. Published by Universities.®

Discipline
Institution
Keyword
Publication Year
Publication
Publication Type
File Type

Articles 2251 - 2280 of 2834

Full-Text Articles in Food and Drug Law

Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola Jan 2007

Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola

Northwestern Journal of International Law & Business

The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational …

Go to article

Title Iii Of The Bioterrorism Act: Sacrificing U.S. Trade Relations In The Name Of Food Security, Claire S. Boisen Jan 2007

Title Iii Of The Bioterrorism Act: Sacrificing U.S. Trade Relations In The Name Of Food Security, Claire S. Boisen

American University Law Review

Part I examines in detail the two conflicting laws that are the basis of this Comment—Title III of the Bioterrorism Act and the SPS Agreement—focusing on those portions of Title III that adversely impact international trade. Part I also presents the WTO case EC Measures Concerning Meat and Meat Products (Hormones), the first food regulation case disputed in the WTO system for a violation of the SPS Agreement. This case clarified the two major principles of the SPS Agreement that are explored in this Comment: the prohibition on discrimination and the obligation to support trade–restrictive measures with an analytical risk …

Go to article

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg Jan 2007

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

Go to article

The Role Of International Agreements In Achieving Food Security, Jack A. Bobo Jan 2007

The Role Of International Agreements In Achieving Food Security, Jack A. Bobo

Vanderbilt Journal of Transnational Law

This Article discusses how international agreements impact the ability of science and technology to enhance food security. International agreements, domestic laws, and regulations have the power to promote scientific research and the adoption of new technology through effective, efficient, and predictable science-based regulatory systems, or to impede development and adoption of new technology by miring it in burdensome or unnecessary regulations. This Article examines the disparate impacts of international agreements on food security through a case study of agricultural biotechnology. In particular, the Article looks at the principles and guidelines for risk assessment developed by the Codex Alimentarius Commission and …

Go to article

Legislative Implementation Of The Food Chain Approach, Jessica Vapnek Jan 2007

Legislative Implementation Of The Food Chain Approach, Jessica Vapnek

Vanderbilt Journal of Transnational Law

Food safety is an essential element of food security, since "adequate" food means food that is not only available, but also safe. Food safety systems have traditionally focused on end-product testing, which is an unsatisfactory means of ensuring safe food. An increasing focus on prevention has spurred interest in a food chain approach, which aims to control all steps in the food chain from production to consumption. Although the approach has drawn international attention in recent years, national lawmakers have lacked guidance on its implementation. This Article serves that need. Part II of the Article describes the international backdrop to …

Go to article

Attack Of The Balloon People, Keith E. Sealing Jan 2007

Attack Of The Balloon People, Keith E. Sealing

Vanderbilt Journal of Transnational Law

Any discussion of food security would, at first blush, seem to focus primarily on world hunger and other threats to the safety of the food supply, whether intentionally man-made (e.g., terrorism), inadvertently man-made (e.g., global warming), made-for-profit by industrial agriculture (referred to as "industrial food" throughout this Article), or "natural" although arguably man-abetted (such as bovine spongiform encephalopathy, or mad cow disease). And hunger is indeed a problem and likely to become more of a problem. However, this Article focuses on the long term threat to world health and world food security caused by the American way of eating; the …

Go to article

Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam Jan 2007

Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam

Vanderbilt Journal of Transnational Law

This Article explores the globalization of food safety concerns driven by the phenomenon of economic globalization, and the "legalization" of food safety disputes within the rules-based architecture of the World Trade Organization (WTO). Focusing on the interaction between WTO norms and the treaties of other multilateral organizations, the Article discusses the implications of the "clash of food safety regulatory regimes" for South-North asymmetrical relations between the rich and poor countries. The Article also discusses global economic diplomacy and the emerging WTO jurisprudence on the Agreement on Sanitary and Phyto-Sanitary Measures (SPS) disputes. This Article explores both the perceived and actual …

Go to article

Food Safety And Security: What Tragedy Teaches Us About Our 100-Year-Old Food Laws, Caroline S. Dewaal Jan 2007

Food Safety And Security: What Tragedy Teaches Us About Our 100-Year-Old Food Laws, Caroline S. Dewaal

Vanderbilt Journal of Transnational Law

The United States food safety system is antiquated and failing. The laws that form the foundation of our food protection and govern the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were enacted over 100 years ago. While some new powers were given to FDA with the Bioterrorism Act of 2002, funding has not kept pace. Safe Food International (SF), a coalition of consumer organizations from around the world, created a set of guidelines outlining an ideal national food safety program. The current system in the United States falls short of that goal. The outbreaks …

Go to article

Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg Jan 2007

Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The panel decision in Abigail Alliance, which found a constitutional right to use certain medicines that have not received Food and Drug Administration approval, may not survive further review, but it already stands as an important signpost on the road to further deregulation of the drug market. This trend mirrors the evolution of the in vitro fertilization (IVF) industry which is remarkably unregulated although it raises numerous ethical and consumer protection issues. These developments share an obvious libertarian underpinning, but in both cases it is an odd sort of libertarianism, because proponents of unmediated access to drugs and IVF also …

Go to article

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai Jan 2007

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

Go to article

A Penny For Your Thoughts: Private And Collective Contracting For Traditional Medicinal Knowledge Modeled On Bioprospecting Contracts In Costa Rica, Katie Bates Jan 2007

A Penny For Your Thoughts: Private And Collective Contracting For Traditional Medicinal Knowledge Modeled On Bioprospecting Contracts In Costa Rica, Katie Bates

Georgia Law Review

For decades, pharmaceutical companies have prospected biologically diverse developing countries for plants and molecules that may form the foundations of groundbreaking medicines. In many cases, native populations have aided researchers by directing them to the plants used in their traditional medicines. Only recently, however, have native peoples pushed for compensation for this valuable contribution. The governments of developing countries, too, have begun to assert legal and physical control over their natural resources, making access to these resources by pharmaceutical companies more difficult and costly. Simultaneously, scientific developments have made drug discovery through alternative methods more feasible. Despite these changes, it …

Go to article

The Plan B For Plan B: The New Dual Over-The-Counter And Prescription Status Of Plan B And Its Impact Upon Pharmacists, Consumers, And Conscience Clauses, Brittany L. Grimes Jan 2007

The Plan B For Plan B: The New Dual Over-The-Counter And Prescription Status Of Plan B And Its Impact Upon Pharmacists, Consumers, And Conscience Clauses, Brittany L. Grimes

Georgia Law Review

On August 24,2006, the U.S. Food and Drug Administration decided to approve Plan B, the "morning-after"contraceptive pill, as an over-the-counter drug for women ages eighteen and older only. Individuals aged seventeen years and younger must still obtain a prescription in order to purchase Plan B, resulting in confusion and complications in implementing the age limitation. Additionally, the dual status of Plan B as both a prescription and over-the-counter drug might still be undermined by pharmacists choosing to refuse sale of contraceptives under various state protective conscience clauses. This Note explores the impact of the FDA's novel decision to create a …

Go to article

Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey Jan 2007

Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey

Georgia Law Review

Trans fat was developed by chemists at the turn of the century and became an increasingly large part of the American diet. Trans fat in the form of partially hydrogenated vegetable oil now makes up 2% of all calories consumed in the United States. In the past two decades, studies have shown that artificially created trans fat increases cholesterol and increases the risk of coronary heart disease, heart attack, and type II diabetes. In response to these health concerns, New York City's Board of Health voted to ban trans fat from restaurant fare in December 2006. Other cities and local …

Go to article

Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn Dec 2006

Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn

Amicus Briefs & Court Filings

Plaintiffs in this case seek a preliminary injunction to prevent the enforcement of the New Hampshire Prescription Confidentiality Act, which protects consumers and the privacy interests of doctors in the state of New Hampshire from the increasingly common practice of using doctor-identifying information in prescription records to facilitate targeting of pharmaceutical marketing and gifts toward doctors who prescribe the most expensive drugs for their patients. This practice raises drug costs for all New Hampshire residents and compromises the professional autonomy of doctors. This brief addresses the failure of the plaintiffs to show that they are likely to succeed on the …

Go to article

An Information Prescription For Drug Regulation, Anita Bernstein, Joseph Bernstein Dec 2006

An Information Prescription For Drug Regulation, Anita Bernstein, Joseph Bernstein

Buffalo Law Review

No abstract provided.

Go to article

European Union Food Law Update, Nicole Coutrelis Dec 2006

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On March 31, 2006, the European Commission published Council Regulation (EC) No. 510/2006 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs. This new regulation repealed Council Regulation (EEC) No. 2081/92 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs mainly to bring Community law into conformity with the World Trade Organization (WTO) agreements and the findings of a recent WTO panel. Under the new Regulation, persons in third countries (non-European Union members) are entitled to address applications for the protection of geographic names and statements of objection …

Go to article

Contents, Journal Editors Dec 2006

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Go to article

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook Dec 2006

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Go to article

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill Dec 2006

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

Go to article

Animal Identification And Traceability Under The Us National Animal Identification System, Margaret Rosso Grossman Dec 2006

Animal Identification And Traceability Under The Us National Animal Identification System, Margaret Rosso Grossman

Journal of Food Law & Policy

The identification of animals has a long history in the United States. Since the late nineteenth century, livestock producers have used brands to mark their animals. Ear tags and other marks now identify individual animals or animals from a specific producer, but not all livestock are identified to facilitate traceability.

Go to article

Journal Of Food Law & Policy - Fall 2006, Journal Editors Dec 2006

Journal Of Food Law & Policy - Fall 2006, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Go to article

'Beastly Bureaucracy' Animal Traceability, Identification And Labeling In Eu Law, Bernd M.J. Van Der Meulen, Annelies A. Freriks Dec 2006

'Beastly Bureaucracy' Animal Traceability, Identification And Labeling In Eu Law, Bernd M.J. Van Der Meulen, Annelies A. Freriks

Journal of Food Law & Policy

This contribution discusses animal traceability, identification and labeling requirements in European Union (EU) law. The requirements are lex specialis to more general requirements in EU food law. The aim is to set out this body of EU law and provide some understanding regarding its background. Along with the article by Margaret Rosso Grossman, it enables the reader to compare the EU system to the United States system.

Go to article

A Complete Property Right Amendment, John H. Ryskamp Oct 2006

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Go to article

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm Oct 2006

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …

Go to article

Water Forum 2006, Susan Kelly Oct 2006

Water Forum 2006, Susan Kelly

Publications

No abstract provided.

Go to article

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy Sep 2006

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy

ExpressO

Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by …

Go to article

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner Sep 2006

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.

Go to article

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco Aug 2006

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco

ExpressO

This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs, including Thomas …

Go to article

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis Aug 2006

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis

ExpressO

The Food and Drug Administration (FDA) has promulgated a new 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 the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of prescription drug …

Go to article

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski Aug 2006

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security …

Go to article

First Prev Next Last