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Full-Text Articles in Food and Drug Law

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.

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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 …

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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 …

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The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg Jan 2002

The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg

Book Chapters

The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …

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Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green Dec 1997

Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green

University of Michigan Journal of Law Reform

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …

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The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox Apr 1986

The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox

University of Michigan Journal of Law Reform

This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.

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The Supreme Court's Opinion In The Inwood Case: Declination Of Duty, Kenneth B. Germain Jan 1982

The Supreme Court's Opinion In The Inwood Case: Declination Of Duty, Kenneth B. Germain

Kentucky Law Journal

No abstract provided.

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Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer Oct 1977

Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer

University of Michigan Journal of Law Reform

This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …

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The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review Mar 1977

The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review

Michigan Law Review

Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …

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Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof Jan 1976

Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof

University of Michigan Journal of Law Reform

This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.

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The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig Jan 1972

The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig

University of Michigan Journal of Law Reform

This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.

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Governmental Regulation Of The Drug Industry, J. Mark Hiebert Jan 1970

Governmental Regulation Of The Drug Industry, J. Mark Hiebert

Cleveland State Law Review

In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a legitimate …

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