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 2431 - 2460 of 2834

Full-Text Articles in Food and Drug Law

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer May 2003

Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer

Vanderbilt Law Review

In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …

Go to article

Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone May 2003

Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone

Michigan Law Review

With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …

Go to article

Myths Of Voluntary Compliance: Lessons From The Starlink Corn Fiasco, Rebecca M. Bratspies Apr 2003

Myths Of Voluntary Compliance: Lessons From The Starlink Corn Fiasco, Rebecca M. Bratspies

William & Mary Environmental Law and Policy Review

No abstract provided.

Go to article

Random Drug Testing For Extracurricular Activites: Has The Supreme Court Opened Pandora's Box For Public Schools?, Ralph D. Mawdsley Mar 2003

Random Drug Testing For Extracurricular Activites: Has The Supreme Court Opened Pandora's Box For Public Schools?, Ralph D. Mawdsley

Brigham Young University Education and Law Journal

No abstract provided.

Go to article

Drug Regulations And The Constitution After Western States, Margaret Gilhooley Mar 2003

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

Go to article

The Fordham Law Drug Policy Reform Project: America's Oldest War: The Efficacy Of United States Drug Policy, John Nicholas Iannuzzi, Graham Boyd, Asa Hutchinson Jan 2003

The Fordham Law Drug Policy Reform Project: America's Oldest War: The Efficacy Of United States Drug Policy, John Nicholas Iannuzzi, Graham Boyd, Asa Hutchinson

Fordham Urban Law Journal

The Fordham Law Drug Policy Reform Project planned and executed the debate, "America's Oldest War: The Efficacy of United States Drug Policy," on April 23, 2002 at the end of the organization's first year. The goal of the debate was to bring to one forum the leading voices at both ends of the drug policy spectrum. Professor John Nicholas Iannuzzi moderated, giving each speaker three minutes to answer each question from the floor. Over one hundred and twenty professionals, students, and community members attended the debate.

Go to article

Engaging The Debate: Reform Vs. More Of The Same, Kevin B. Zeese Jan 2003

Engaging The Debate: Reform Vs. More Of The Same, Kevin B. Zeese

Fordham Urban Law Journal

This Essay dispels common myths put forward by drug war advocates and describes more effective alternatives available than present policy contemplates. We all want to prevent adolescent drug abuse, protect the health and safety of the community, deny drug profits to terrorists and other criminals, and develop a drug policy that works and is based on our common humanity, as well as on research and reality, rather than myth and rhetoric. The essential paradigm shift that needs to occur is to move away from a policy dominated by law enforcement . . . and toward a policy based on public …

Go to article

Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg Jan 2003

Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg

UIC Law Review

No abstract provided.

Go to article

Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer Jan 2003

Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer

Faculty Scholarship

Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …

Go to article

Reaching Through The Genome, Rebecca S. Eisenberg Jan 2003

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

Go to article

The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh Jan 2003

The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh

Faculty Publications

This article addresses the question as to whether a federal court has the authority to compel a pharmaceutical company to disgorge profits obtained from an alleged violation of the FDCA, specifically the failure of a pharmaceutical company to comply with current good manufacturing practices (GMPs). Section II of this article summarizes the article to which we are responding. In all fairness, it did not purport to be a full-blown defense, and we expect the agency's comprehensive defense of disgorgement would be considerably more detailed. Section III turns to the Sixth Circuit case on which FDA rests its argument for disgorgement, …

Go to article

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg Jan 2003

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …

Go to article

Going To Pot, Carl E. Schneider Jan 2003

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Go to article

Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas Jan 2003

Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas

Michigan Journal of International Law

This Article is the first in a series of studies of the globalization of illicit markets. My theses are as follows: First, the increase in international trade in illicit products and services parallels the growth in international trade more generally that accompanies the phenomenon of globalization. Second, at the same time that most international trade law has moved toward a posture of liberalization, there has been a movement to strengthen the prohibition and punishment of trade in illicit transactions. Third, the mechanisms that have developed to regulate this prohibition constitute a significant development in the international legal order.

Go to article

An Effective Drug Policy To Protect America's Youth And Communities, Asa Hutchinson Jan 2003

An Effective Drug Policy To Protect America's Youth And Communities, Asa Hutchinson

Fordham Urban Law Journal

Drug abuse and addiction, and the government's response to these problems, are frequently and appropriately a topic for public debate. Law enforcement has made significant advances in both reducing the number of people using illegal drugs and in the fight against traffickers. Legalization of illegal drugs would not elinate the black market or eliminate drug-related violence. The facts on the issue make a strong case for a national policy geared toward effective drug abuse education and prevention, and treatment for people dependent on illegal drugs. Our nation should also continue to conduct research to determine the most effective means of …

Go to article

Report Of The Task Force On The Use Of Criminal Sanctions To The King County Bar Association Board Of Trustees Jan 2003

Report Of The Task Force On The Use Of Criminal Sanctions To The King County Bar Association Board Of Trustees

Fordham Urban Law Journal

The King County formed the Task Force on the Use of Criminal Sanctions as part of the King County Bar Association's Drug Policy Project to examine current criminal sanctions related to the non-medical use of drugs both in Washington and on the federal level. The founders charged the Task Force with the goal of assessing the effectiveness of criminal sanctions in reducing both illegal drug use and drug-related crime, and assessing the public costs associated with the use of criminal sanctions. The Task Force drew specific conclusions regarding the state response to drug use and the provision of drug addiction …

Go to article

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg Jan 2003

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.

Go to article

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg Jan 2003

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.

Go to article

Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas Jan 2003

Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas

Cornell Law Faculty Publications

This Article is the first in a series of studies of the globalization of illicit markets. My theses are as follows: First, the increase in international trade in illicit products and services parallels the growth in international trade more generally that accompanies the phenomenon of globalization. Second, at the same time that most international trade law has moved toward a posture of liberalization, there has been a movement to strengthen the prohibition and punishment of trade in illicit transactions. Third, the mechanisms that have developed to regulate this prohibition constitute a significant development in the international legal order.

Go to article

Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba Jan 2003

Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba

Public Interest Law Reporter

No abstract provided.

Go to article

Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup Jan 2003

Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup

Public Interest Law Reporter

No abstract provided.

Go to article

Can We Talk? About Food And Drug Regulation And The First Amendment, Marsha N. Cohen Jan 2003

Can We Talk? About Food And Drug Regulation And The First Amendment, Marsha N. Cohen

Faculty Scholarship

No abstract provided.

Go to article

New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois Jan 2003

New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois

Vanderbilt Journal of Transnational Law

In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the …

Go to article

The Academy Chokes On Food Biotech, Public Policy Suffocates, Henry I. Miller Jan 2003

The Academy Chokes On Food Biotech, Public Policy Suffocates, Henry I. Miller

Richmond Journal of Law & Technology

The National Academy of Sciences, under its 1863 congressional charter, is supposed to be dedicated to “investigate, examine, experiment, and report upon any subject of science or art whenever called upon to do so by any department of the government.” At least insofar as judging the scienti c integrity of governmental regulation of biotechnology is concerned, however, two recent “expert” committees of the National Research Council (NRC), the research arm of the Academy, have been plagued by apparent bias, and their recommendations have been dubious.

Go to article

Problem-Solving Courts: From Innovation To Institutionalization, Michael C. Dorf, Jeffrey A. Fagan Jan 2003

Problem-Solving Courts: From Innovation To Institutionalization, Michael C. Dorf, Jeffrey A. Fagan

Faculty Scholarship

The phenomenal growth of drug courts and other forms of "problem-solving" courts has followed a pattern that is characteristic of many successful innovations: An individual or small group has or stumbles upon a new idea; the idea is put into practice and appears to work; a small number of other actors adopt the innovation and have similar experiences; if there is great demand for the innovation – for example, because it responds to a widely-perceived crisis or satisfies an institutional need and resolves tensions within organizations that adopt it – the innovation rapidly diffuses through the networks in which the …

Go to article

Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman Jan 2003

Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

In this article I will argue that Internet pharmacies pose a significant public health problem, as they raise the classic eternal triangle of health care issues--access, quality, and financing--in a new technological context. Part II describes the phenomena of Internet pharmacies, and Part III reviews the present regulatory scheme. Part IV explains why the current legal framework is inadequate to address the public health and safety problems posed by Internet pharmacies, focusing particularly on the jurisdictional, constitutional, and practical obstacles to effective state oversight of Internet pharmacies. Part V argues that comprehensive federal oversight of Internet prescribing and dispensing is …

Go to article

Public Perceptions Of Food Safety: Assessing The Risks Posed By Genetic Modification, Irradiation, Pesticides, Microbiological Contamination And High Fat/High Calorie Foods, Michael D. Mehta Dec 2002

Public Perceptions Of Food Safety: Assessing The Risks Posed By Genetic Modification, Irradiation, Pesticides, Microbiological Contamination And High Fat/High Calorie Foods, Michael D. Mehta

The University of New Hampshire Law Review

[Excerpt] "In general, people in the developed world have access to a safe and varied supply of food. Instead of systemic hunger, many developed countries have problems with obesity and other kinds of eating disorders among their citizenry. It is within this context that some find public concerns about the safety of food both paradoxical and misplaced. Nevertheless, understanding how people perceive the risk associated with food is an important exercise in demonstrating accountability and in setting priorities for regulation. With the advent of technologies for producing genetically modified foods, and the development of fat blockers like Olestra, the public …

Go to article

Importing Death As A Part Of Free Trade: An Argument For A Prohibition On The Importation Of Foods Containing The Residue Of Banned Pesticides, Derek Redmond Oct 2002

Importing Death As A Part Of Free Trade: An Argument For A Prohibition On The Importation Of Foods Containing The Residue Of Banned Pesticides, Derek Redmond

William & Mary Environmental Law and Policy Review

No abstract provided.

Go to article

Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher Jun 2002

Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher

Michigan Telecommunications & Technology Law Review

The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …

Go to article

The Rx-To-Otc Switch Of Claritin, Allegra, And Zyrtec: An Unprecedented Fda Response To Petitioners And The Protection Of Public Health, Holly M. Spencer Jun 2002

The Rx-To-Otc Switch Of Claritin, Allegra, And Zyrtec: An Unprecedented Fda Response To Petitioners And The Protection Of Public Health, Holly M. Spencer

American University Law Review

No abstract provided.

Go to article

First Prev Next Last