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Food and Drug Law

2006

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Articles 1 - 19 of 19

Full-Text Articles in Law

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

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 …


Water Forum 2006, Susan Kelly Oct 2006

Water Forum 2006, Susan Kelly

Publications

No abstract provided.


Drugged, Carl E. Schneider Jul 2006

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …


Active Water Resource Management: Tools For Better Water Management, John D'Antonio May 2006

Active Water Resource Management: Tools For Better Water Management, John D'Antonio

Publications

No abstract provided.


Water For Energy In The Southwest: Where Will It Come From?, Marilyn C. O'Leary May 2006

Water For Energy In The Southwest: Where Will It Come From?, Marilyn C. O'Leary

Publications

No abstract provided.


Water For Energy In The Southwest: Finding Water For Mohave, Stanley M. Pollack May 2006

Water For Energy In The Southwest: Finding Water For Mohave, Stanley M. Pollack

Publications

No abstract provided.


Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann May 2006

Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann

Law Faculty Articles and Essays

Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.


The Use Of Hair Analysis To Test Children For Exposure To Methamphetamine, Michael T. Flannery, Jerry Jones, Karen Farst, Karen Bord Worley Apr 2006

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

Faculty Scholarship

No abstract provided.


Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah Jan 2006

Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah

Faculty Scholarship

The Author reviews Michele Goodwin’s book BLACK MARKETS: THE SUPPLY AND DEMAND OF BODY PARTS, published by Cambridge University Press, 2006. The book discusses the shortage of cadaveric organs available for transplantation. It argues that the shortage disproportionately impacts racial minorities. It then analyzes existing organ procurement laws and proposed alternatives, with a focus on market solutions.

BLACK MARKETS is impeccably researched and persuasively argued, though some of its points are certainly controversial. The book is aimed at and very accessible to a general audience, but it will also prove interesting and informative to legal, medical and public health academic …


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 Jan 2006

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 …


Scientific Secrecy And "Spin": The Sad, Sleazy Saga Of The Trials Of Remune, Susan Haack Jan 2006

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

Articles

No abstract provided.


The Right To Food: Holding Global Actors Accountable Under International Law, Smita Narula Jan 2006

The Right To Food: Holding Global Actors Accountable Under International Law, Smita Narula

Elisabeth Haub School of Law Faculty Publications

Economic globalization represents both an unmet opportunity and a significant challenge for the fulfillment of social and economic rights, including the right to food. While corporate sector accountability and the responsibility of international financial institutions (IFIs) to ensure social and economic rights are now at the forefront of the globalization discourse, greater attention must be paid to how these actors can be held accountable under international law. The existing human rights legal framework is ill-equipped to deal with violations committed by non-state actors, such as transnational corporations (TNCs), and multi-state actors, such as IFIs. Using the right to food as …


The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn Jan 2006

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. …


Labeling Genetically Modified Food: Comparative Law Studies From Consumer's Perspective, Christopher C. H. Chen Jan 2006

Labeling Genetically Modified Food: Comparative Law Studies From Consumer's Perspective, Christopher C. H. Chen

Research Collection Yong Pung How School Of Law

This article focus on the genetically modified food and labelling requirement. The relatively new technology raises some concerns over the safety of food containing genetically modified substance. The "substantial equivalent" doctrine, adopted by the U.S., and the "precautionary" doctrine, taken by the EU, represent two contradictory approaches to reconcile new biotechnology and consumer protection, a difference influenced by politics or food industry rather than by consumer attitudes. In this article, we argue that consumers cannot make their own choices and exercise market power without a certain degree of disclosure of information. However, even though food labelling is an effective way …


An Environmental Pool For The Rio Grande, Kara Gillon Jan 2006

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 …


Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson Jan 2006

Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson

Faculty Scholarship

When I chose the title, Counterfeit Drugs: The Good, the Bad and the Ugly, some of my colleagues at this symposium blanched. They understood counterfeit drugs as Bad and Ugly, but resisted categorizing any counterfeit drug as Good. This article is intended to be provocative, challenging some of the conventional wisdom concerning counterfeit drugs.

We start with the fact that reports about the scope of pharmaceutical counterfeiting are remarkably anecdotal rather than empirical. As a professor once chided me, the plural of anecdote is not data. The FDA and the WHO must undertake comprehensive market surveillance to establish the true …


Paying For Delay: Pharmaceutical Patent Settlement As A Regulatory Design Problem, C. Scott Hemphill Jan 2006

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, …


Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman Jan 2006

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 …


Conscience And Emergency Contraception, Leslie C. Griffin Jan 2006

Conscience And Emergency Contraception, Leslie C. Griffin

Scholarly Works

No abstract provided.