Volume 59 Issue 1
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Table of Contents
> Anchors Away: The Food and Drug Administration’s Use of Disgorgement Abandons Legal Moorings
by William W. Vodra, Partner in the law firm of Arnold & Porter LLP, Washington, D.C.
> The First Amendment and Federal Court Deference to the Food and Drug Administration: The Times They Are A-Changin’
by Edward M. Basile, Senior Partner with the law firm of King & Spalding LLP, Washington, D.C., and head of the firm’s FDA Practice Group.
> Managing Physician Financial Conflicts of Interest in Clinical Trials Conducted in the Private Practice Setting
by Kevin W. Williams, Director, Regional and Medical Research Specialists, U.S. Medical, Pfizer Global Pharmaceuticals, Pfizer Inc., New York, NY.
> Shrinking Waters in the Safe Harbor: Has Integra Lifesciences v. Merck Turned the Tide by Narrowing Available Exempted Infringing Uses? by Angela M. Davison, Associate with the law firm of Gifford, Krass, Groh, Sprinkle, Anderson & Citkowski, P.C., Birmingham, MI.
> Legal Strategies to Address the Misrepresentation of Vermont Maple Syrup by H. David Gold, Associate at Hale and Dorr LLP, Boston, MA. This paper was the First Place winner in the 2003 H. Thomas Austern Memorial Writing Awards Long Paper Competition sponsored by the Food and Drug Law Institute.
> European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for U.S. Patent Law and Public Policy: A Case Study of the Myriad Genetics’ BRCA Patent Controversy
by Jordan Paradise, Legal Fellow with the Institute for Science, Law and Technology at the Chicago-Kent College of Law, Illinois Institute of Technology, Chicago, Ill. This paper was the First Place winner in the 2003 H. Thomas Austern Memorial Writing Awards Short Paper competition sponsored by the Food and Drug Law Institute.
> Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament
by David C. McPhie, Law Clerk to the Honorable Samuel A. Alito, Jr., U.S. Court of Appeals for the Third Circuit. This paper was the Second Place winner in the 2003 H. Thomas Austern Memorial Writing Awards Short Paper competition sponsored by the Food and Drug Law Institute.
> America’s First Drug Regulation Regime: The Rise and Fall of the Import Drug Act of 1848 by Wesley J. Heath, Associate with Shearman & Sterling LLP, Washington, D.C.
Anchors Away: The Food and Drug Administration’s Use of Disgorgement Abandons Legal Moorings Authors: William W. Vodra and Arthur N. Levine
Issue: 59 Food and Drug Law Journal 1-30 (2004).
During the past several years, the Food and Drug Administration (FDA) has renewed a decades-old pursuit of restitution and disgorgement to enforce alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA). This effort has produced three consent decrees containing multi-million dollar payments to the U.S. Treasury that purport to represent disgorgement of ill-gotten gains. Previous articles in the Food and Drug Law Journal have debated whether a federal court, when issuing an injunction under the FDCA, has jurisdiction to grant an ancillary order for equitable monetary relief such as disgorgement.
Without conceding that a court has such jurisdiction, this article addresses the fundamental elements of the equitable remedy of disgorgement and demonstrates that FDA’s recent actions depart significantly from the historic precedents. When a court has equitable jurisdiction, it may only order divestiture of unjust enrichment and cannot impose or enforce a penalty. FDA has failed to ensure that its use of disgorgement does not exceed such enrichment. Profound issues are thus presented for FDA, courts, and regulated companies. This article recommends that FDA take affirmative actions to ensure that this enforcement tool is not improperly used in the future. Until it takes those steps, FDA should suspend its use of the disgorgement remedy. Further, in the future, the agency must seek independent case-by-case judicial evaluation of the remedy.
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The First Amendment and Federal Court Deference to the Food and Drug Administration:
The Times They Are A-Changin’
Author: Edward M. Basile and Melanie Gross
Issue: 59 Food and Drug Law Journal 31-44 (2004).
Recent federal court decisions reveal a growing tension between the Food and Drug Administration’s (FDA’s) regulatory efforts and the courts’ heightened vigilance in protecting the First Amendment, as well as preserving consumer access to truthful and accurate information through First Amendment commercial speech jurisprudence. This article presents an overview of the historical framework of judicial deference accorded FDA in light of recent First Amendment commercial speech jurisprudence. It posits that increased opposition to FDA’s policies and their enforcement sheds critical light on FDA and jeopardizes its role as an effective gatekeeper of consumer health and welfare.
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Managing Physician Financial Conflicts of Interest in Clinical Trials Conducted
in the Private Practice Setting
Author: Kevin W. Williams
Issue: 59 Food and Drug Law Journal 45-78 (2004).
The conduct of clinical trials, once the exclusive province of the academic research institution, has made significant inroads into the private practice setting over the past several years, and private practice physicians increasingly find themselves balancing the best interests of the patient against the potential financial conflicts of interest that arise in the research setting. The private practice physician who engages in clinical trials must juggle his duty as a clinician, which first and foremost must be to safeguard the patient’s health and welfare, against his duty as a researcher, which, by its nature, subordinates the best interests of the patient to the interests of the research study. This article examines the potential conflict that arises when clinical trials are imported into the private practice setting and the effect that this might have on the doctor-patient relationship. After looking at the history of informed consent and financial conflicts of interest in both the private practice and research settings, this article offers a number of safeguards to ensure that adequate disclosure of any potential financial conflicts of interest that might affect the physician’s judgment is provided to the patient in order to protect his or her deliberative autonomy.
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Shrinking Waters in the Safe Harbor:
Has Integra Lifesciences v. Merck Turned the Tide by Narrowing Available Exempted Infringing Uses?
Author: Angela M. Davison
Issue: 59 Food and Drug Law Journal 79-92 (2004).
35 U.S.C. § 271(e)(1), colloquially known as the “Safe Harbor” provision, states generally that it is not an act of infringement to make, use, offer to sell, or sell within the United States a patented invention solely for uses reasonably related to the development and submission of information to a federal regulatory agency. This provision usually comes into play when a generic drug manufacturer begins testing to obtain Food and Drug Administration (FDA) approval for a generic equivalent of a brand name drug. Before the Safe Harbor provision was enacted, generic drug manufacturers could not conduct FDA approval-related testing until the patent on the brand name drug expired because such tests constituted acts of infringement. Section 271(e)(1) was designed to give generic drug manufacturers the freedom to conduct FDA-related testing without fear of an infringement suit. The language used in section 271(e)(1), however, has proven to be ambiguous and difficult to interpret. Courts initially interpreted the activities protected by section 271(e)(1) narrowly. For over the past ten years, however, the infringing activities protected by the safe harbor proved quite expansive. The Federal Circuit’s decision in Integra v. Merck may signal a jurisprudential return to narrowly interpreting the scope of activities protected by section 271(e)(1). This article will first examine the history and policies leading to the enactment of section 271(e)(1). The article also examines how the federal judiciary has interpreted the Safe Harbor provision since its enactment. Finally, the article will discuss the Integra decision and its ramifications.
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Legal Strategies to Address the Misrepresentation of Vermont Maple Syrup
Authors: H. David Gold
Issue: 59 Food and Drug Law Journal 93-132 (2004).
In recent years, the Food and Drug Administration (FDA) has focused its efforts on food safety and nutrition, only sporadically exercising its authority to police representations about the geographic origin, purity, and quality of food products. Meanwhile, consumers have become more interested in the origin of foods, and food producers have increasingly recognized the value of brands. As a result, misrepresentation of food products has become a widespread problem, creating consumer confusion and undermining the reputation of food producers. This problem has harshly affected Vermont maple syrup producers. FDA and others must take a more vigilant stance to address the misrepresentation of Vermont maple syrup and other foods. Available legal strategies include securing trademarks, obtaining marketing orders, negotiating in the shadow of existing laws, reformulating standards of identity, creating an appellation of origin system, and establishing new labeling requirements.
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European Opposition to Exclusive Control Over Predictive Breast Cancer Testing
and the Inherent Implications for U.S. Patent Law and Public Policy:
A Case Study of the Myriad Genetics’ BRCA Patent Controversy
Author: Jordan Paradise
Issue: 59 Food and Drug Law Journal 133-154 (2004).
Controversy over gene patents has arisen due to a variety of issues, including their relatively recent arrival into the patent realm, their grant of exclusivity over specific sequences of human genes, and their effect on research and diagnosis. These issues ultimately reflect both legal factors, dealing directly with the application of patent laws—and policy factors—implicating problems of access, cost, and quality in both the patient realm and the research setting. Because many gene patents either directly claim or include genes and/or the corresponding proteins that are essential to genetic diagnosis, a grant of exclusivity may hinder both healthcare and the advancement of scientific technology. There currently is an unparalleled legal challenge underway in the European Union regarding a number of human gene patents held by Myriad Genetics, a U.S. corporation, for sequences of two genes, BRCA1 and BRCA2, mutations in which indicate a predisposition to breast cancer. Specifically, the most recent opposition challenges the patent as not fulfilling relevant provisions in the European patent law, as well as impeding heathcare and scientific discovery. This article addresses the European controversy over the BRCA1 gene patent and offers potential mechanisms to resolve similar legal and policy concerns in the United States.
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Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament
Author: David C. McPhie
Issue: 59 Food and Drug Law Journal 155-168 (2004).
In early 2003, two panels of the Federal Circuit clashed in a pair of cases (Warner-Lambert v. Apotex and Allergan v. Alcon) dealing with the question of whether an action for inducement of infringement could be leveled against a generic drug manufacturer seeking Food and Drug Administration approval for an unpatented drug with both patented and unpatented uses. This article takes up this debate, analyzing the interpretive puzzles presented in the application of the intricate Hatch-Waxman Act to this set of facts, arguing that the correct interpretation weaves elements from both panels' approaches. It finishes with an alternative solution borrowed from a lesson in copyright.
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America’s First Drug Regulation Regime: The Rise and Fall of the Import Drug Act of 1848
Author: Wesley J. Heath
Issue: 59 Food and Drug Law Journal 169-200 (2004).
Tracing the passage, administration, and repeal of the Import Drug Act of 1848, this paper provides a comprehensive view of America’s first major attempt at drug regulation. While applying only to imported drugs, the 1848 act was an ambitious federal regulatory program in an age better known for its laissez faire attitudes. Even though the act enjoyed overwhelming support in Congress and the medical community, its first few years of administration presented many new challenges. The Customs Service was successful in integrating these early lessons into a highly efficient enforcement system that seems to have greatly reduced the problem of imported adulterated drugs. Despite its success, the act was to fall victim to the federal government’s growing regulatory ambitions. In addition to addressing a largely neglected topic in drug regulation history, this paper seeks to make a minor contribution to the history of the rise of the American regulatory state.
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