Food and Drug Law Commons^™

Rio Grande Reservoir Symposium: Federal Perspective - Upper Rio Grande Operations Model And Urwops Update, April Sanders

Publications

No abstract provided.

Historic El Vado Reservoir Operations, Viola Sanchez

Publications

No abstract provided.

Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon

Michigan Telecommunications & Technology Law Review

Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …

The Unjust Exclusion Of Gay Sperm Donors: Litigation Strategies To End Discrimination In The Gene Pool, Luke A. Boso

West Virginia Law Review

No abstract provided.

"It's The Right Thing To Do": Why The Animal Agriculture Industry Should Not Oppose Science-Based Regulations Protecting The Welfare Of Animals Raised For Food, Angela J. Geiman

Michigan Law Review First Impressions

Since the beginning of history, people have used farm animals to assist with their work and to provide a source of food. These agricultural pursuits were not questioned; rather, they were a widely-accepted way of life. In fact, many people still say that the very purpose of livestock on this Earth is to provide these resources for mankind. As for the proper way to treat our livestock, we commonly hear farmers and livestock producers make comments like, “If we take care of the animals, they will take care of us,” and, “We treat our animals well because that’s just good …

One Bad Day: Thoughts On The Difference Between Animal Rights And Animal Welfare, Neil D. Hamilton

Michigan Law Review First Impressions

The lawsuit pitting the New Jersey Society for the Prevention of Cruelty to Animals against the New Jersey Department of Agriculture brings into sharp focus the issue of animal rights versus animal welfare that has been dividing animal activists, farmers, and society for decades. On one side are proponents of animal rights—a set of rights articulated by humans but granted to animals to govern how we treat them. For many believers this includes the right not to be owned and certainly not to be eaten. On the other side are proponents of animal welfare—also a set of human derived standards …

A Case Study On Cruelty To Farm Animals: Lessons Learned From The Hallmark Meat Packing Case, Nancy Perry, Peter Brandt

Michigan Law Review First Impressions

“I need the public to understand that my office takes all cases involving animal cruelty very seriously . . . [and i]t doesn’t matter whether the mistreated animal is a beloved family pet or a cow at a slaughterhouse. Unnecessary cruelty will not be tolerated and will be prosecuted to the fullest extent allowed by law.” San Bernardino County District Attorney Michael A. Ramos (February 15, 2008) One morning in January 2008, images of horrific animal cruelty were blasted by Internet, television, and print media throughout the country. The story was all the more shocking in that the animals at …

Is Preemption Right For You - The Third Circuit Applies Preemption To A Misleading Drug Advertisement Claim In Pennsylvania Employee Benefit Trust Fund V. Zeneca, Inc., Diana Rabeh

Villanova Law Review (1956 - )

No abstract provided.

Local Agriculture Perspectives In The Middle Rio Grande Valley, Cecilia Rosacker-Mccord

Publications

No abstract provided.

A Basin-Wide Approach To Water Management In The Middle Rio Grande Valley, Rolf Schmidt-Petersen

Publications

No abstract provided.

Model Interstate Water Compact, Ken Knox

Publications

No abstract provided.

Advisory Committee Recommendations - The Utton Center Model Interstate Water Compact, State Bar Center, State Bar Of New Mexico

Publications

No abstract provided.

United States Food Law Update, A. Bryan Endres

Journal of Food Law & Policy

Michael T. Roberts and Margie Alsbrook noted in the Journal's inaugural Food Law Update that "[t]he one constancy about food law in the United States is change, especially in a rapidly-developing food industry." This observation holds true today and also augurs a change in authorship of this section of the Journal. I hope to follow my colleagues' lead and provide timely and cogent updates of the federal (and occasionally state) statutes, regulations, and judicial decisions impacting food law and policy. It is both an honor and a duty, as food and its legal implications remain in many respects "the world's …

Hemp ... Why Not?, Jared B. Kahn

ExpressO

Hemp ... Why Not?

By: Jared Kahn

(Abstract)

Industrial hemp has been utilized as a commodity crop for centuries in the United States, and for millennia throughout the world. Today, the crop is cultivated for industrial uses in thirty countries, but not the United States. United States citizens may import hemp, eat hemp, wear hemp, and do whatever they please with a manufactured hemp product, but nobody grows the valuable crop in the U.S. Several states have legalized industrial hemp cultivation, however, the federal Drug Enforcement Agency (DEA) interprets the Controlled Substances Act (CSA) to prohibit the growing of hemp …

The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh

Michigan Telecommunications & Technology Law Review

Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …

The Fda And The Future Of The Brain-Computer Interface: Adapting Fda Device Law To The Challenges Of Human-Machine Enhancement, 25 J. Marshall J. Computer & Info. L. 117 (2007), Eric Chan

UIC John Marshall Journal of Information Technology & Privacy Law

No abstract provided.

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 …

Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher

Michigan Telecommunications & Technology Law Review

Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …

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 …

Winning The Battle, But Perhaps Losing The War: Endorsing Deregulation Of Emergency Contraception At The Expense Of Derogating Abortion, Melissa Bond

Cardozo Journal of International and Comparative Law

No abstract provided.

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 …

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.

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.

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 …

'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.

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.

Water Forum 2006, Susan Kelly

Publications

No abstract provided.

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.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.