FDLI Publications: Food and Drug Law Journal 57-1

Volume 57 Issue 1

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> Regulation of Dietary Supplements: FDA's Strategic Plan
by Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)

> FDA Has Substantial and Sufficient Authority to Regulate Dietary Supplement
by Stephen H. McNamara, Partner at Hyman, Phelps & McNamara, P.C., Washington, D.C.
A. Wes Siegner, Jr., Partner at Hyman, Phelps & McNamara, P.C.,
Washington, D.C.

> Maintaining a Level Playing Field: The Need for a Uniform Standard to Evaluate Health Claims for Foods and Dietary Supplements
by Clement Dimitri Pappas, Attorney in the Office of Ballard, Spahy, Andrews & Ingersoll, LLP, Philadelphia, PA

> General Principles in the Regulatory Requirements for Health
by No-Seong Kwak, Research Fellow at the Korea Institute for Health & Social Affairs, Seoul, Korea
David John Jukes, Senior Lecturer at the University of Reading, United Kingdom

> Regulation of Natural Health Products in Canada
by Gordon S. Jepson, Partner at Deeth Williams Wall LLP, Toronto, Canada

> Considering Changes to CMS's National Coverage Decision Process: Applying Lessons Learned from FDA as a Regulator of Access to Healthcare Technology
by Christopher D. Zalesky, Director, Health Care and Marketing Compliance, Centocor, Inc., Malvern, PA and a fourth-year student at Widener University School of Law, Wilmington, DE

> Humanitarian Use Devices
by Max Sherman, Vice President, Clinical Research and Regulatory Affairs, DePuy Orthopaedics, Inc., Warsaw, IN
Steve Wentworth, Manager, Clinical Research-Product Development, DePuy Orthopaedics, Inc., Warsaw, IN
Lynette Walker, Vice President, Spine Vision, Inc., Atlanta, GA

> Lost Food and Liability: The Good Samaritan Food Donation Law Story
by David L. Morenoff, Associate with the law firm of Troutman Sanders LLP, Washington, D.C.

> Ethics of AIDS Clinical Trials in Developing Countries: A Review
by Lisa Pitler, Associate at Platinum Legal Services, PC, Northbrook, IL > The Right to a Jury Trial Under the Waxman-Hatch Act—The Question Revisited and Resolved
by Brian D. Coggio, Senior Partner at Pennie & Edmonds, LLP, New York, NY
Timothy E. DeMasi, Partner at Pennie & Edmonds, LLP, New York, NY

Regulation of Dietary Supplements: FDA's Strategic Plan
Author: Joseph A. Levitt
Issue: 57 Food and Drug Law Journal 1-13 (2002).

This article provides an update on how the Food and Drug Administration (FDA) is implementing the Dietary Supplement Health and Education Act of 1994 (DSHEA). This article highlights 1) some of the critical issues the Center for Food Safety and Nutrition's (CFSAN's) stakeholders identified at public meetings as priority issues to be addressed in CFSAN's Dietary Supplement Strategic Plan (DSSP); 2) the basic parameters and mechanism FDA used to develop the DSSP; and 3) where things stand with respect to some of the highest priority efforts.

Public meetings with stakeholders have been part of a general way of doing business that CFSAN's Director has initiated since becoming Director in February 1998. FDA held two public stakeholders' meetings geared specifically toward the development of the DSSP-one in Washington, D.C. and the other in Oakland, CA.

The DSSP integrates law and science. The goal of the program is: "By the year 2010, to have a science-based regulatory program that fully implements DSHEA, thereby, providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products." To achieve full implementation of DSHEA, the DSSP is organized under six headings: Safety; Labeling; Boundaries; Enforcement; Science Base; and Outreach. FDA uses this DSSP as its blueprint for implementing DSHEA, and describes yearly planned activities as part of CFSAN's annual program priority-setting process.

FDA Has Substantial and Sufficient Authority to Regulate Dietary Supplements
Author: Stephen H. McNamara & A. Wes Siegner, Jr.
Issue: 57 Food and Drug Law Journal 15-24 (2002).

Recently, there has been considerable public debate about whether the Food and Drug Administration (FDA) has sufficient authority under current law to regulate dietary supplements that provide vitamins, minerals, herbs, or other dietary ingredients. This article explains why Congress enacted the current form of the law that governs dietary supplements. It then reviews the essential features of the current legislation and maintains that current law provides ample and sufficient protection for the public health if FDA administers the law appropriately.

Maintaining a Level Playing Field:
The Need for a Uniform Standard to Evaluate Health Claims for Foods and Dietary Supplements
Author: Clement Dimitri Pappas
Issue: 57 Food and Drug Law Journal 25-41 (2002).

This article examines the recent decision of Pearson v. Shalala and examines its effect on health claims by food and dietary supplement manufacturers. This article begins by discussing the Food and Drug Administrations' (FDA's) resistance to health claims since the passage of the Nutrition Labeling and Education Act in 1990 and the court's decision in Pearson, which limited the FDA's ability to keep non-misleading information from consumers. Because of both FDA's intransigence and dietary supplement manufacturers' willingness to pursue their legal entitlement, this article predicts that the Pearson decision may lead to the emergence of different standards for evaluating health claims for foods and dietary supplements. It concludes by discussing the harms that could result from FDA's different standards of evaluation and proposes several alternative regulatory approaches for the agency to consider.

General Principles in the Regulatory Requirements for Health Claims
Author: No-Seong Kwak & David John Jukes
Issue: 57 Food and Drug Law Journal 43-58 (2002).

Regarding the general principles applicable to various health claims in the Codex, they generally are accepted internationally that significant health benefits should be realized within a total diet context, in accordance with national public health and nutrition policies. Various measures including a disqualifying level, minimum nutrients level, and threshold level have been considered to implement the above principle.

Until recently, national authorities, industry, and consumer organizations have established, or proposed, several requirements for health claims in a number of countries including Japan, the United Kingdom, and the United States. These requirements were, however, designed to take into account national problems and circumstances. It appears difficult, therefore, to apply these requirements directly to the regulatory system of other countries. It is necessary, when considering the establishment of an acceptable international control framework for functional foods, to assess the general principles, which have been developed in national proposals and regulations, and to identify and comment upon their main components.

Regulation of Natural Health Products in Canada
Author: Gordon S. Jepson
Issue: 57 Food and Drug Law Journal 59-71 (2002).

This article addresses the current (as of the beginning of 2002) and future regulatory regimes in Canada for what are called "dietary supplements" in the United States and will now be called "natural health products" in Canada. It addresses the fact that most products currently are drugs in Canada, but may often be marketed as "products subject to special measures" with a lower level of scientific proof (and at a lower regulatory cost) than conventional drugs. This article also examines the proposed new Natural Health Products Regulations and the Natural Health Products Directorate that will administer them, with particular attention to the licensing regime that will be introduced by these pending regulations. The new regulations are contrasted with the U.S. system under the Dietary Supplement Health and Education Act. This article also examines the extent of enforcement of the current regulations, and considers the likely impact of the new regulations.

Considering Changes to CMS's National Coverage Decision Process:
Applying Lessons Learned from FDA as a Regulator of Access to Healthcare Technology
Author: Christopher D. Zalesky
Issue: 57 Food and Drug Law Journal 73-93 (2002).

The considerable recent political and public interest in a Medicare prescription drug benefit raises questions about the process that the Centers for Medicare and Medicaid (CMS ) (formerly HCFA) will use to cover breakthrough drugs, especially expensive new biotechnology drugs that can halt disease, prevent hospitalization, and/or save lives. This article discusses the current CMS national coverage decision process and the growing criticism that the process lacks openness, accountability, and speed. It draws parallels between CMS and the Food and Drug Administration (FDA) as regulators of access to new healthcare technology and illustrates how a "modernized" FDA balances its mission to protect the public health with its mission to speed access to new drugs and medical devices. This article also discusses application of a CMS/FDA interagency agreement as one method to accomplish the needed changes at CMS. Such an arrangement is modeled on successful application of a current CMS/FDA interagency agreement implementing certain requirements of the Clinical Laboratory Improvement Amendments.

Humanitarian Use Devices
Author: Max Sherman, Steve Wentworth & Lynette Walker
Issue: 57 Food and Drug Law Journal 95-105 (2002).

Humanitarian use device (HUD) provisions were added to the 1938 Federal Food, Drug, and Cosmetic Act with the enhancement of the 1990 Safe Medical Devices Act. The provisions are a boon to patients with rare diseases (those that affect fewer than 4,000 individuals in the United States) and grant manufacturers an expedited pathway to market products with limited usage. The disadvantage is that manufacturers cannot realize a profit from HUDs, as the amount charged must not exceed the cost of research, development, fabrication, and distribution. To market HUDs, manufacturers must obtain HUD status from the Food and Drug Administration's Office of Orphan Products Development and comply with the Humanitarian Device Exemption (HDE) regulations. The HDE submission requirements are similar in most respects to those required in a premarket approval application, without extensive clinical evidence collected to support efficacy. Also, the time frame for review is much shorter. Postapproval requirements for approved HDE holders are similar to those required for premarket approval applications, including the submission of supplements for periodic review.

Lost Food and Liability: The Good Samaritan Food Donation Law Story
Author: David L. Morenoff
Issue: 57 Food and Drug Law Journal 107-132 (2002).

According to recent studies, the United States throws away more than one quarter of the food it produces. This sobering statistic begs the question of why the country wastes so much food while hunger afflicts millions of Americans.

Over the past quarter century, Good Samaritan food donation laws have emerged as a tool that may alleviate this problem. These measures seek to encourage donations of food by limiting the liability of food donors. Since 1977, every state has enacted a Good Samaritan food donation law, and Congress has passed two such measures at the federal level.

This article traces the growth of the movement for Good Samaritan food donation laws. It also examines the current situation concerning these measures, exploring unresolved legal issues and the impact of these laws on hunger relief efforts. This last issue may be the most important, because if Good Samaritan food donation laws fulfill their promise, they could do much to combat the hunger that stands as an obstacle to a substantial part of the American population achieving its full potential.

Ethics of AIDS Clinical Trials in Developing Countries: A Review
Author: Lisa Pitler
Issue: 57 Food and Drug Law Journal 133-154 (2002).

Acquired immunodeficiency syndrome (AIDS) is a devastating disease that dramatically has impacted the world. While there is no cure for AIDS, antiretroviral agents are available and used for treatment to prolong life, and to decrease mother to child transmission (MTCT). In the United States and other industrialized countries, these agents are readily accessible. In the developing countries, however, the limitations on healthcare systems and cost restraints severely restrict access to therapy. Recently, numerous placebo-controlled trials have been conducted in the developing countries to study treatments for the prevention of MTCT, and in the treatment of tuberculosis and other sexually transmitted diseases in people infected with the virus. The conduct of these studies has raised numerous ethical issues regarding the standards that should be used to protect the rights and welfare of human subjects who participate in research. This article reviews the ethical issues addressed and analyzes the adequacy/feasibility of applying the safeguards and regulations available for human subjects participating in research in the United States, to the human subjects participating in research in developing countries.

The Right to a Jury Trial Under the Waxman-Hatch Act—The Question Revisited and Resolved
Author: Brian D. Coggio & Timothy E. DeMasi
Issue: 57 Food and Drug Law Journal 155-160 (2002)

The Waxman-Hatch Act created a new and artificial action for patent infringement based on the filing of an abbreviated new drug application (ANDA) seeking approval to market a pharmaceutical product before expiration of the relevant patents. The action and the exclusive remedies for such infringement are codified in 35 U.S.C. §§ 271(e)(2) and 271(e)(4), respectively. Uncertainty existed as to whether these ANDA-based infringement actions could be tried to a jury. Indeed, this topic was discussed in a 1997 article in this publication. Recent decisions have confirmed the authors' earlier conclusion that neither the statute nor the Seventh Amendment permits a jury trial in these actions; moreover, this result is not altered by the assertion of counterclaims for invalidity or noninfringement.