Food and Drug Law Commons^™

The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

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 …

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 …

Food For Sport Or Faustian Bargain: Regulating Performance Enhancing Dietary Supplements, Jennifer Kay Braman

Cleveland State Law Review

The defining line between legal and illegal substance-between dietary supplement and drug is horribly skewed. Accordingly, Part I of this Note will investigate the complexities that exist with regard to the classification and regulation of dietary supplements, looking at the history leading to the passage of the governing Dietary Health and Supplement Act of 1994. Part II will focus on supplements that consumers may use for performance enhancement purposes, and the regulation of sports products. Part III will look at the regulatory debate over dietary supplements, the andro product example and the interrelationship between drugs and sport. Part IV will …

Regulation Of Dietary Supplements: Five Years Of Dshea, Laura A.W. Khatcheressian

Law Faculty Publications

On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA),2 passed unanimously by both houses of Congress. This law radically changed the regulatory landscape for the sale and labeling of dietary supplements, restricting the Food and Drug Administration's (FDA's) authority in certain ways, and encouraging the sale of dietary supplements, including vitamins, minerals, herbs, botanicals, and amino acids.

This article examines DSHEA and discusses current FDA attempts to regulate dietary supplements. Part II provides a brief background and discusses FDA's concerns and attitude toward dietary supplements before the passage of DSHEA. Part III …

Does The Fda Have Authority To Regulate Human Cloning?, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Examines the FDA's statutory authority to regulate human cloning.

A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue

Articles

The first criticism is that the proposed resolution would not require manufacturers and, in tum, consumers to pay anything approaching the true total costs of cigarettes, costs that we estimate to be at least $7 per pack, a number that is considerably higher than other estimates that have been reported in the media. Our estimate includes some, but not all, of the costs borne ultimately by smokers themselves, by smokers' insurers, and by individuals injured by second-hand smoke. It includes only future costs and excludes many of those. So, for example, the figure includes neither the health-care costs that have …

Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore

Articles

Although nothing is certain in Washington, sweeping federal legislation in the cigarette area is more likely now than has ever been the case. Congress is currently considering several proposals for comprehensive federal regulation of the cigarette market, a market that has until now gone largely untouched by government intervention. Among those proposals, the one that has received the most attention, and the one that in fact motivated policy makers to look anew at the problems posed by cigarettes, is the proposed national tobacco resolution (the "Proposed Resolution"). The Proposed Resolution, which has been advanced by a coalition of state attorneys …

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 …

Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale For The Fda Regulatory Compliance Defense, W. Kip Viscusi, Steven R. Rowland, Howard L. Dorfman, Charles J. Walsh

Vanderbilt Law School Faculty Publications

This Article examines the interaction between direct regulation of pharmaceuticals under the Federal Food Drug and Cosmetic Act (FDCA) and the indirect regulation of pharmaceuticals provided by common law tort incentives. The Article concludes that tort liability is generally inappropriate in cases where manufacturers have complied with the FDCA. The Article begins with a description of the FDCA's operation, and provides an overview of the Food and Drug Administration's (FDA) role in the drug approval process and drug labeling. This overview will demonstrate the need for centralized control over drug labeling. Moreover, we will provide an explanation of the costs …

The Unconstitutional Conditions Doctrine And Mandating Norplant For Women On Welfare Discourse, Laurence C. Nolan

American University Journal of Gender, Social Policy & the Law

No abstract provided.

International Regulatory Harmonization: A New Era In Prescription Drug Approval, David W. Jordan

Vanderbilt Journal of Transnational Law

Critics of the Food and Drug Administration (FDA) have asserted that the agency's process of reviewing new drugs has long been laden with inefficiency and waste and, as a result, new drugs are not made available to consumers on a timely basis. This Note considers the veracity of this claim by examining the history of prescription drug regulation in the United States and the current procedure by which new drugs are reviewed. This Note also addresses the limited extent to which the FDA has interacted with its foreign counterparts in assessing the safety and efficacy of new drugs and the …

Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles

Cleveland State Law Review

It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …

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.

Reducing Diet-Induced Cancer Through Federal Regulation: Opportunities And Obstacles, Richard A. Merrill

Vanderbilt Law Review

For more than a decade, federal health regulatory agencies have devoted major attention to controlling human exposure to substances believed capable of causing cancer. These efforts have evoked a broad spectrum of criticism; government has been accused of both indolence in the face of an incipient epidemic' and reckless distortion of science to support restrictions on substances that present only trivial risks. A central object of regulatory concern has been the safety of the food supply. At least since the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act),'with its famous Delaney Clause, the Food …

Regulating Carcinogens In Food: A Legislator's Guide To The Food Safety Provisions Of The Federal Food, Drug, And Cosmetic Act, Richard A. Merrill

Michigan Law Review

On March 9, 1977, the Food and Drug Administration (FDA) announced that a study in laboratory rats conducted by the Canadian government confirmed that saccharin is an animal carcinogen. For this reason, the agency stated, the sweetener must be banned from human food.

The studies which Congress mandated, to be accompanied by the recommendations of the Secretary of HEW, are likely to generate a fundamental reexamination of the nation's current food safety policies. This Article attempts to aid this inquiry by explaining the requirements of the present law. The Article describes the several statutory provisions that govern the regulation of …

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, …

The Food And Drug Administration And The Economic Adulteration Of Foods, Wesley E. Forte

Indiana Law Journal

No abstract provided.

The Formulation And Review Of Regulations Under The Food, Drug, And Cosmetic Act, Ralph F. Fuchs

Articles by Maurer Faculty

No abstract provided.