Volume 50 Issue 2
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Table of Contents
> Daubert v. Merrell Dow Pharmaceuticals:
Active Judicial Scrutiny of Scientific Evidence
> Living With and Reforming the Delaney Clause
> A De Minimis Exception to the Delaney
Clause: A Reassessment of Les v. Reilly
> The Dietary Supplement and Health Education
Act of 1994
> The Changing Environment in Health Care—Introduction
> Recent Multistate Enforcement Initiatives:
Prescription Drug Promotional Practices
> Competition and Antitrust Enforcement in the
Changing Pharmaceutical Marketplace
> Drug Marketing from an OIG Enforcement Perspective
> Pharmaceutical Industry Restructuring and New
Marketing Approaches: Enforcement Responses
> Remarks by the Commissioner of Food and Drugs
> Current Issues in the Pioneer Versus Generic
Drug Wars
Daubert v. Merrell Dow Pharmaceuticals: Active Judicial Scrutiny of Scientific Evidence
Author: Edward W. Kirsch
Issue: 50 Food and Drug Law Journal 213-234 (1995)
The Supreme Court's opinion in Daubert v. Merrell Dow Pharmaceuticals, Inc. replaces the long-standing Frye test governing the admissibility of scientific evidence with a new standard that places a premium on scientific validity and reliability. The Daubert standard represents a significant improvement over the Frye test and the "reasonable medical certainty" test previously utilized to scrutinize expert testimony in toxic tort cases. The standard rightly focuses judicial attention on an often-neglected issue in toxic tort litigation-whether the proffered testimony is based on scientifically valid reasoning connecting facts to conclusions. The inquiry required by the Daubert test will force judges to scrutinize scientific studies and evidence with which they are uncomfortable. This is preferable to allowing a case to degenerate into a battle of experts without a referee. In such battles, juries' conclusions purport to rely on science but often are based on dubious reasoning and are at odds with the view of the scientific community as expressed in the literature.
Living with and Reforming the Delaney Clause
Author: Frederick H. Degnan and W. Gary Flamm
Issue: 50 Food and Drug Law Journal 235-256 (1995)
Efforts to reform the "Delaney Clause" are underway in full force. The Clause has been under attack for years from various quarters because of the zero-risk premise on which it is based. In many cases, sound science permits the conclusion that the risks to humans from exposure to animal carcinogens are either negligible or not meaningful from a human carcinogenic endpoint.
In spite of the controversial nature of the Clause, less than ten compounds have been banned under its authority. This is largely the result of the manner in which the Food and Drug Administration (FDA) has employed sound scientific principles and judgment in implementing the Clause. Simply stated, the FDA's use of sound science in deciding whether a substance "induces cancer" within the meaning of the Clause has limited significantly the unscientific effects that a legalistic interpretation of the Clause naturally would foster. Awareness of the FDA's history of reliance on sound science is essential to informed efforts to revise and modify the Clause and to guarantee that future statutory requirements are implemented reasonably and wisely.
A De Minimis Exception to the Delaney Clause:
A Reassessment of Les v. Reilly
Author: Douglas T. Sheehy
Issue: 50 Food and Drug Law Journal 257-284 (1995)
The abundance of fruits, vegetables, and grains in the United States is due in part to the pervasive use of pesticides in this country's agricultural industry. As medical science has linked nutrition and good health, it also has determined that some pesticides cause cancer and cancer-related diseases. Amidst the debate over the continued use of pesticides, the Environmental Protection Agency (EPA) announced a de minimis exception by which pesticide residues would be permitted in foods if their cancer-causing risk was trivial. In a decision that will have anomalous results, the Ninth Circuit in Les v. Reilly rejected EPA's interpretation of the Delaney Clause. This article outlines the statutory framework that regulates the use of carcinogenic substances, discusses and analyzes the court's decision in Les v. Reilly, explores the societal and political implications of the Les decision, and recommends congressional action to preserve EPA's de minimis exception regarding pesticides. Ultimately, this article concludes that the zero-risk Delaney Clause has outlived its regulatory utility.
The Dietary Supplement and Health Education Act of
1994
Authors: Anthony L. Young and I. Scott Bass
Issue: 50 Food and Drug Law Journal 285-292 (1995)
The Dietary Supplement and Health Education Act of 1994 (DHSEA) was enacted by unanimous consent on the final days of the 103d Congress. Borne out of compromise between proponents of health freedom of choice and advocates of traditional Food and Drug Administration (FDA) regulation and premarket approval schemes, DSHEA provides new and expanded opportunities for those marketing vitamins, minerals, herbs, and other dietary supplement products. Under certain conditions, DSHEA exempts published literature from the definition of "labeling" and permits its use in product sales. DSHEA also permits certain statements about the effects of products so long as a disclaimer is included that the FDA has not evaluated the statement. In addition, DSHEA mandates a separate nutrition information labeling scheme for dietary supplements, different from that recently imposed on other food products. Premarket approval is not found in the Act. Instead, premarket notification and the provision of information is required for new ingredients and postmarket notification is all that is required for certain new product statements. One guiding principle is that labeling not be false or misleading. Another guiding principle is that the FDA bears the burden of proof that dietary supplements are not safe. DSHEA's concepts reverse the FDA trend for tighter regulation and premarket clearance.
The Changing Environment in Health Care—Introduction
Author: Donald O. Beers
Issue: 50 Food and Drug Law Journal 293-294 (1995)
The marketing of pharmaceuticals is changing over time. The regulated industry realizes this, as do the regulators, and all are in the process of developing strategies to deal with the issues raised by the new reality. Some of these issues are addressed in the following group of articles that originally were presented at a Food and Drug Law Institute annual meeting panel on changes in the health care environment. These articles represent important perspectives on this topic, namely that of both federal and state regulators and the pharmaceutical industry.
Recent Multistate Enforcement Initiatives: Prescription
Drug Promotional Practices
Author: David Woodward
Issue: 50 Food and Drug Law Journal 295-300 (1995)
Various state attorneys general have been active in recent years in launching enforcement initiatives involving the application of state consumer protection laws to various business practices within the health care industry. This article reviews a number of these state initiatives, including two multistate settlements addressing pharmacist payment programs sponsored by pharmaceutical companies, and briefly raises questions focusing on some consumer protection implications arising from recent acquisition activity within the health care marketplace. This article reflects the author's oral presentation on a panel devoted to federal and state enforcement issues at the December 1994 annual meeting of The Food and Drug Law Institute.
Competition and Antitrust Enforcement in the Changing
Pharmaceutical Marketplace
Author: Lisa A. Foley
Issue: 50 Food and Drug Law Journal 309-312 (1995)
The Office of the Inspector General (OIG), Department of Health and Human Services, has a statutory mandate to police the integrity and quality of the federally-funded Medicare and Medicaid programs, among others. The OIG has a substantial interest in prescription drugs due to increasing federal payments for these items and the substantial number of program beneficiaries receiving them. Prescription drug marketing is a focus of OIG scrutiny because marketing practices may violate the Medicare and Medicaid anti-kickback provision. This law prohibits the knowing and willful payment of anything of value to induce, or in return for, patient referrals (including recommending or arranging for provision of an item that is payable by Medicare or Medicaid). Anti-kickback violators are subject to criminal prosecution and/or administrative sanction. In August 1994, the OIG issued a Special Fraud Alert describing marketing practices that are considered potential violations and that have been subject to OIG investigation.
Drug Marketing from an OIG Enforcement
Author: Lisa A. Foley
Issue: 50 Food and Drug Law Journal 309-312 (1995)
The Office of the Inspector General (OIG), Department of Health and Human Services, has a statutory mandate to police the integrity and quality of the federally-funded Medicare and Medicaid programs, among others. The OIG has a substantial interest in prescription drugs due to increasing federal payments for these items and the substantial number of program beneficiaries receiving them. Prescription drug marketing is a focus of OIG scrutiny because marketing practices may violate the Medicare and Medicaid anti-kickback provision. This law prohibits the knowing and willful payment of anything of value to induce, or in return for, patient referrals (including recommending or arranging for provision of an item that is payable by Medicare or Medicaid). Anti-kickback violators are subject to criminal prosecution and/or administrative sanction. In August 1994, the OIG issued a Special Fraud Alert describing marketing practices that are considered potential violations and that have been subject to OIG investigation.
Authors: Stephen Paul Mahinka and Kathleen M. Sanzo
Issue: 50 Food and Drug Law Journal 313-326 (1995)
Over the past few years, there has been an ongoing, unprecedented restructuring of the pharmaceutical industry. New approaches to pharmaceutical marketing and distribution have been a major consequence of this restructuring. These new approaches primarily have occurred in response to exogenous changes in the structure of the U.S. health care system, principally the development of large managed-care buyers of health care products and services. This substantial restructuring of the pharmaceutical industry has been accompanied by an enormous amount of attention and enforcement activity by both federal regulatory and antitrust enforcement agencies, particularly the Food and Drug Administration, the Federal Trade Commission, the Office of the Inspector General of the Department of Health and Human Services, and by the state attorneys general under their consumer protection laws.
Legitimate and serious questions can be raised as to whether this enforcement attention and activity is well-founded economically or analytically and whether it is likely to enhance market competition, produce consumer benefits, or contribute to the safe and effective use of pharmaceutical products. Many of the state and federal agencies' activities appear, rather, to be premature responses to a rapidly changing pharmaceutical industry. Significant risks are presented by such premature enforcement activity, potentially resulting in less efficient or cost-effective functioning of the pharmaceutical industry to the detriment of consumers and government and private purchasers of health care products and services. In view of the scope and number of enforcement activities, however, industry members must assess carefully the trends of enforcement when developing new marketing approaches and considering acquisitions and strategic alliances in response to the changing health care system.
Remarks by the Commissioner of Food and Drugs
Author: David A. Kessler
Issue: 50 Food and Drug Law Journal 327-334 (1995)
This article is based on remarks presented by the Commissioner at The Food and Drug Law Institute's 38th Annual Educational Conference. Dr. Kessler provides a retrospective on the activities of the Food and Drug Administration (FDA) since he assumed the position of Commissioner in 1990. He expresses appreciation for the dedication of FDA employees to the agency's mission of protecting the public health, and reviews the various Centers' changes and accomplishments. The article also discusses the plans of the FDA to respond to the demands of the future.
Current Issues in the Pioneer Versus Generic Drug
Wars
Author: Peter O. Safir
Issue: 50 Food and Drug Law Journal 000-000 (1995)
Both pioneer and generic drug manufacturers have been active in asserting their rights. Aggressive strategies to protect brand name products are a central part of any research-based company's long-range plans. There is a fine line between an aggressive approach and anti-competitive activities that can lead to antitrust challenges from competitors and regulators. This article highlights some of the recent developments in this area and provides a brief review of some controversies that await decision.