Volume 59 Issue 4
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Table of Contents
> 2004 Update—180-Day Exclusivity Under the Hatch-Waxman Amendments
to theFederal Food, Drug, and Cosmetic Act
by Erika King Lietzan, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C.
> The Use of Food and Drug Administration 510(k) Notifications in Patent Litigation
by Deborah E. Tolomeo, registered patent agent and the founder of Amicus Engineering, a consulting company specializing in preclinical aspects of Food and Drug Administration (FDA) submissions, San Jose, CA
> Drug Marketing Exclusivity Under United States and European Union Law
by Valerie Junod, a lawyer at the Swiss law firm of Junod, Guyet, Muhlstein & Lévy.
> Legal Implications of Pharmacogenomics Regarding Drug Trials, Drug Labeling, and Genetic Testing for Drug Prescription: An International Approach by Tilo Mandry, LL.M., an attorney in Munich, Germany.
> Deterring the Importation of Counterfeit Pharmaceutical Products
by Douglas W. Stearn, attorney with the Office of Consumer Litigation in the U.S. Department of Justice. The views expressed in this paper are the author's and do not necessarily represent the policy or the views of the Department
> Mandatory Recall Authority: A Sensible and Minimalist Approach to Improving Food Safety
by Michael T. Roberts, Research Associate Professor of Law and Director of the National Agricultural Law Center, University of Arkansas School of Law, Fayetteville, Ark.
> The Federal Trade Commission's Regulation of Weight-Loss Advertising Claims
by Edward Correia, Attorney with the law firm of Latham & Watkins LLP, Washington, D.C. He was formerly an Assistant Regional Director and Senior Attorney Advisor at the Federal Trade Commission.
> Avoiding Legal and Ethical Pitfalls of Industry-Sponsored Research:
The Co-Existence of Research, Scholarship, and Marketing in the Pharmaceutical Industry
by Howard L. Dorfman, Senior Counsel at Bayer Pharmaceuticals Corporation, West Haven, Conn.
Linda Pissott Reig, Principal at the law firm of Porzio, Bromberg & Newman, P.C., in Morristown, N.J. and defends drug companies in product liability lawsuits, as well as counsels drug companies in pharmaceutical marketing and sales compliance.
> The Food and Drug Administration's Actions on Ephedra and Androstenedione:
Understanding Their Potential Impacts on the Protections of the Dietary Supplement Health and Education Act
by A. Wes Siegner, Jr., Director at the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.
2004 Update—180-Day Exclusivity Under the Hatch-Waxman Amendments to the
Federal Food, Drug, and Cosmetic Act
Author: Erika King Lietzan
59 Food and Drug Law Journal 459-464 (2004).
This article updates the author's previously published Food and Drug Law Journal article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.
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The Use of Food and Drug Administration 510(k) Notifications in Patent Litigation
Author: Deborah E. Tolomeo
59 Food and Drug Law Journal 465-478 (2004).
The U.S. Food and Drug Administration (FDA) 510(k) approval process provides market clearance for a device that is "substantially equivalent" to one or more predicate devices. In preparation of a 510(k) notification, FDA practitioners should be aware that they are creating a public document that may later reappear as evidence in patent litigation. This article reviews a selection of decisions in which a court has admitted a 510(k) notification as relevant evidence toward a determination of patent infringement, patent invalidity, patent unenforceability, and personal liability of a corporate officer. This article further proposes general strategies to minimize future risk.
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Drug Marketing Exclusivity Under United States and European Union Law
Author: Valerie Junod
59 Food and Drug Law Journal 479-518 (2004).
This article sets forth a comprehensive analysis of United States and European Union law governing drug marketing/data exclusivity. The practical usefulness of exclusivity is evaluated. The article then describes the requirements that a pioneer drug company must meet to obtain marketing/data exclusivity. It reviews the consequences of this exclusivity on second applicants relying on data previously submitted by the pioneer company. The 2004 changes in the E.U. Community code relating to medicinal products for human use are considered as they affect the period of exclusivity granted to drugs submitted for approval after November 2005. Recent European case law delineating the scope of data exclusivity also is analyzed.
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Legal Implications of Pharmacogenomics Regarding Drug Trials, Drug Labeling,
and Genetic Testing for Drug Prescription: An International Approach
Author: Tilo Mandry
59 Food and Drug Law Journal 519-536 (2004).
Pharmacogenomics applies genomic technology to discover and develop drugs, as well as to treat patients with drugs more effectively. This article identifies potential legal questions raised by this approach to drug development and delivery. It offers possible solutions to these potential problems, analyzing the law in both the United States and the European Union. Factors that affect drug response are described briefly. Genetic testing might enable clinicians to carry out clinical drug trials on selected subjects who respond more favorably to the drug than unscreened subjects. A drug could be approved under such a "narrow trial." Do current Food and Drug Administration regulations and European Community law allow this new practice? How can the drug safety of these drugs be guaranteed?
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Deterring the Importation of Counterfeit Pharmaceutical Products
Author: Douglas W. Stearn
59 Food and Drug Law Journal 537-562 (2004).
This article considers issues related to the criminal prosecution of cases involving the importation of counterfeit pharmaceutical products. First, the article discusses the dangers posed by this problem by reviewing the prevalence of counterfeit pharmaceutical products abroad and the various means by which these products can enter the United States. Second, the article discusses the legal framework for dealing with the problem, including the applicability of U.S. law, past efforts to improve the exercise of regulatory authority, and possible gaps in U.S. jurisdiction. The article also argues that, given the nature of the problem, credible criminal deterrence is a vital part of the legal framework. Third, the article provides an overview of the difficulties in prosecuting such cases. Prosecutions of counterfeit drug importers generally have relied upon domestically-gathered evidence. The article outlines the practical and legal difficulties in gathering evidence outside the United States and in presenting it at a criminal trial. Finally, the article provides a number of proposals for improving the prospects for criminal prosecutions in this area.
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Mandatory Recall Authority: A Sensible and Minimalist Approach to Improving Food Safety
Author: Michael T. Roberts
59 Food and Drug Law Journal 563-584 (2004).
Recent food-safety events have renewed interest in the debate over whether the government should have the authority to order companies to recall unsafe food from commerce. The government currently does not have the authority to mandate a recall of unsafe food. Recalls of unsafe food products are conducted voluntarily by food companies and are monitored by multiple government agencies. This voluntary recall system has been subjected to severe criticism. This article recommends that the granting of mandatory recall authority to the government—with appropriate safeguards—is a sensible, minimalist approach to the protection of public health. It is sensible because mandatory recall authority would improve a recall system that generally works fairly well, but has on occasion experienced significant breakdowns. It is a minimalist approach because, with appropriate legal and procedural safeguards in place, voluntary recalls would continue to be the norm. In an age of terrorism and food safety concerns, giving the government mandatory recall authority will protect consumers and ensure the well-being of the food industry.
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The Federal Trade Commission's Regulation of Weight-Loss Advertising Claims
Author: Edward Correia
59 Food and Drug Law Journal 585-594 (2004).
This article discusses the role of the Federal Trade Commission (FTC) in policing the advertising of weight-loss products. The legal standards the agency uses in determining whether weight-loss claims are deceptive are discussed, as well as the FTC's recently-released publication, A Reference Guide for Media on Bogus Weight Loss Claim Detection , which identifies claims that the agency views as inherently incapable of substantiation. Finally, the article offers practical advice for advertisers and company personnel who want to substantiate more reasonable—and much less dramatic—claims.
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Avoiding Legal and Ethical Pitfalls of Industry-Sponsored Research:
The Co-Existence of Research, Scholarship, and Marketing in the Pharmaceutical Industry
Authors: Howard L. Dorfman and Linda Pissott Reig
59 Food and Drug Law Journal 595-616 (2004).
The timely release and publication of research results can provide benefits to physicians and their patients. Yet, the pharmaceutical industry faces a dilemma as it wrestles with the question: what are the legal and ethical standards that apply to the process of reporting the results of clinical research? Key considerations are the drug company's interest in protecting its intellectual property and the call for increased disclosure through clinical trial registries. This article provides an overview of some of the considerations, standards, position statements, and guidelines that may apply to the communication of clinical trial results, whether through the posting of information on government or private websites or through the publication of medical articles in peer-reviewed journals.
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The Food and Drug Administration's Actions on Ephedra and Androstenedione: Understanding Their Potential Impacts on the Protections of the Dietary Supplement Health and Education Act
Author: A. Wes Siegner, Jr.
59 Food and Drug Law Journal 617-628 (2004).
Ten years after the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the Food and Drug Administration (FDA) is beginning to take serious regulatory actions that have important impacts on the dietary supplement industry. FDA's actions to remove ephedra and androstenedione have the potential to fundamentally undermine the protections that DSHEA affords to dietary supplements. This article looks back at FDA's pre-DSHEA overreaching to keep dietary supplements off the market, and then examines FDA's recent actions to reveal how the agency once again is attempting to restrict market access in ways that are legally impermissible. Industry must aggressively protect DSHEA to avoid a return to de facto FDA premarket approval of dietary supplements, while encouraging more enforcement of existing authority over product quality and labeling. Proper implementation of DSHEA will ensure market access, continued innovation, and safe and beneficial products.
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