Food and Drug Law Commons^™

Furthering Consumer Safety Of Medical Devices: The Necessity Of A Device-Specific State Law As Required For Express Preemption Under The Mda, Rachel Mervis

Cardozo Law Review

No abstract provided.

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

A Government Of Limited Powers, Carl E. Schneider

Articles

Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …

Liability For Direct Advertising Of Drugs To Consumers: An Idea Whose Time Has Not Come, Aaron Twerski

Faculty Scholarship

No abstract provided.

The Effects Of Price Regulation On Pharmaceutical R&D And Innovation, Heather M. O'Neill, Lena Clarissa Crain

Business and Economics Faculty Publications

As rising health care expenditures focus government attention on slowing the growth, the pharmaceutical industry comes under increasing pressure to curb prices of ethical drugs. Pharmaceutical price regulations have been implemented in many countries to control pharmaceutical expenditures. Yet, creating innovative drugs requires enormous R&D costs, which in turn require adequate expected economic returns. Since price controls reduce profits and expected returns, as countries invoke stricter price regulations, firms will either move their R&D process into less regulated markets or move out of innovative R&D. This paper assesses the impact of drug price regulations in Japan compared to market-priced drugs …

Food Democracy Ii: Revolution Or Restoration?, Neil D. Hamilton

Journal of Food Law & Policy

Author's Note: This essay is a companion to the essay 'Food Democracy, "which appears in 9 Drake Journal of Agricultural Law 9 (2004). In that essay, the author discussed many of the progressive trends that are helping reshape America's food system. These trends have a common denominator in their reflection of the democratic tendencies of the American populace. The desire of an increasing number of consumers to eat better food and to have access to the information, choices, and alternatives that make better food available are helping drive shifts in food production and marketing. Accompanying these shifts are political and …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

The purpose of this update is to present the main events that have taken place each six months in the food law sector in the European Union (E.U.). This presentation will cover June through December 2004, but is not exhaustive. This update will not include detailed discussions of regulations, such as authorizations of new additives for animal feed or registrations of new geographic names. Instead it will concentrate on fundamental topics and focus on food, which excludes from our scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). However, some questions which legally pertain to the …

Food Law & Policy: An Essay, Peter Barton Hutt

Journal of Food Law & Policy

Food has been the driving preoccupation of humans since the dawn of evolution. Exactly when food processing began and when the original hunter-gatherers settled down to develop agriculture-or even the question of which of these occurred first-remain issues of scholarly pursuit and debate. It is clear, however, that these events occurred millennia before the advent of recorded history; therefore, we must rely on largely adventitious discoveries of archeological artifacts to advance our developing knowledge of these events.

Traceability And Labeling Of Genetically Modified Crops, Food, And Feed In The European Union, Margaret Rosso Grossman

Journal of Food Law & Policy

In the last several years, European Union (E.U.) policy has encouraged development of biotechnology, including genetically modified (GM) (that is, bioengineered) agricultural crops. The E.U. developed a strategy for life sciences and biotechnology, directed toward improving the competitiveness of the European biotechnology sector and the general situation for European biotechnology. E.U. documents have acknowledged the potential significance of genetically modified crops-for example, the conclusion in a recent report that "the potential of plant genomics and biotechnology to deliver major advances in our lifestyles and prosperity is enormous. [Biotechnology] can also maintain and enhance the competitiveness of E.U. farmers and food …

Do European Union Non-Tariff Barriers Create Economic Nuisances In The United States?, Thomas P. Redick, Michael J. Adrian

Journal of Food Law & Policy

The European Union's new traceability system for biotech crops will lead to the proliferation of non-tariff barriers affecting biotech crops. This, in turn, will lead to economic dislocation and attendant liability in the United States, which is losing billions of dollars in export trade. A chain of complex legal problems will arise for United States-based companies as they strive to trace particular genetically modified (GM) events and avoid commingling. The European Union (E. U) tracing law for biotech crops applies at each stage of commodity commerce, from grain shippers leading back through elevators, growers, and seed companies. Warranty liability could …

Journal Of Food Law & Policy - Spring 2005, Journal Editors

Journal of Food Law & Policy

No abstract provided.

United States Food Law Update, Michael T. Roberts, Margie Alsbrook

Journal of Food Law & Policy

The one constancy about food law in the United States is change, especially in a rapidly-developing food industry. Innovations in food technology, shifts in popular culture and tastes, concerns of safety and nutrition, pressures from international markets, all contribute to the changing landscape of food law. These changes are reflected in new federal statutes, regulations, administrative decisions, and judicial decisions.

Revising Seed Purity Laws To Account For The Adventitious Presence Of Genetically Modified Varieties: A First Step Towards Coexistence, A. Bryan Endres

Journal of Food Law & Policy

Adoption of genetically modified (GM) seed varieties in the United States, Canada, and South America continues to expand, with GM crops comprising almost 76 million hectares and over 93 percent of the total biotech cropland worldwide. As an increasing number of farmers plant GM varieties, the potential for adventitious mixture of genetically modified DNA with products produced via organic and conventional (non-GM) methods also increases. Many consumers of organic and identity-preserved products, however, object to the adventitious presence of genetically modified DNA at even low levels. Accordingly, the ability of farmers to choose between conventional, organic, or GM crop production …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Adequate Drug Warnings In The Face Of Uncertain Causality: The Learned Intermediary Doctrine And The Need For Clarity, Michael Imbroscio, Gabriel Bell

West Virginia Law Review

No abstract provided.

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

The Impact And Limits Of The Constitutional Deregulation Of Health Claims On Foods And Supplements: From Dementia To Nuts To Chocolate To Saw Palmetto, Margaret Gilhooley

Mercer Law Review

The Food and Drug Administration ("FDA") recently issued an enforcement policy identifying the types of health claims in the disclaimers that are constitutionally permitted on foods and dietary supplements. In 1990 Congress required that before a company could make a health claim on a food product, the FDA must approve the claim as based on significant scientific agreement. While the 1990 law gave the FDA discretion to establish a lesser standard for nutritional supplements than for food products, the FDA chose to apply the same standard. Thus, claims on nutritional supplements had to be supported by significant scientific agreement. Supplement …

Delawate River Basin Compact, Jeffrey Featherstone

Publications

No abstract provided.

Debacle In Dixie: A Story Of Six Rivers, Three States, Two Compacts And One Well-Paved Path, George William Sherk

Publications

No abstract provided.

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh

UIC Law Review

No abstract provided.

Water Privatization And Obstacles To Achieving Millennium Development Goal Seven's Targets For Sustainable Drinking Water, Maria Vanko

Sustainable Development Law & Policy

No abstract provided.

"Racially-Tailored" Medicine Unraveled, Sharona Hoffman

American University Law Review

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling. This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Battle Of The Beef, The Rematch: An Evaluation Of The Latest E.C. Directive Banning Beef Produced With Growth Hormones And The U.S. Refusal To Accept The Directive As Wto Compliant, Darrel Chichester

American University International Law Review

No abstract provided.

Stomaching The Burden Of Dietary Supplement Safety: The Need To Shift The Burden Of Proof Under The Dietary Supplement Health And Education Act Of 1994, Morgan J. Wais

Seattle University Law Review

This article gives a brief historical perspective on dietary supplement regulation and discusses the evolution of drug regulation by the FDA. Part II concludes with a discussion of the political environment in which these regulations occur. Part III gives examples and show how the current system has caused injury and harm to consumers of dietary supplements. Part IV discusses the current burden of proof and how it was applied in the case of ephedra. Part V discusses how, under the current regulatory structure, consumers cannot be adequately protected, either by the FDA or the tort system. Part VI discusses the …

Access To Justice And The Right To Adequate Food: Implementing Millennium Development Goal One, Marc J. Cohen, Mary Ashby Brown

Sustainable Development Law & Policy

No abstract provided.