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Articles 61 - 72 of 72
Full-Text Articles in Food and Drug Law
Title Iii Of The Bioterrorism Act: Sacrificing U.S. Trade Relations In The Name Of Food Security, Claire S. Boisen
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 …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
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 …
The Role Of International Agreements In Achieving Food Security, Jack A. Bobo
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 …
Legislative Implementation Of The Food Chain Approach, Jessica Vapnek
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 …
Attack Of The Balloon People, Keith E. Sealing
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 …
Food Safety, South-North Asymmetries, And The Clash Of Regulatory Regimes, Obijiofor Aginam
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 …
Food Safety And Security: What Tragedy Teaches Us About Our 100-Year-Old Food Laws, Caroline S. Dewaal
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 …
Technology Unbound: Will Funded Libertarianism Dominate The Future?, Steven Goldberg
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 …
Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai
Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai
Faculty Scholarship
No abstract provided.
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 …
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
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 …
Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey
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 …