FDLI Publications: Food and Drug Law Journal 56-1

Volume 56 Issue 1

FDLI's policy regarding the Food and Drug Law Journal online is: Only the Table of Contents and article abstracts for each issue will be posted to our website. Those visitors wishing to obtain a full text version of a particular article, or a copy of an entire issue, may contact FDLI’s Customer Service Department by e-mail at service@fdli.org. Your purchase will be processed quickly, and at reasonable rates.

Any questions or concerns regarding this policy should be directed to
Michael Levin-Epstein, FDLI's Editor-in-Chief.

> The Importance of International Activities to the Work of the Food and Drug Administration's Center
for Food Safety and Applied Nutrition
> Reflections on Delegation in the Chevron Era
> Protecting the Balance of Hatch-Waxman: Understanding the Industry's New Dynamics for the 21st Century
> Guidelines on Gifts to Physicians From Industry: An Update
> WLF and the Two-Click Rule: The First Amendment Inequity of the Food and Drug Administration's Regulation of Off-Label Drug Use Information on the Internet
> Going 90 in a 55 M.P.H. Speed Zone: Reprocessing of Used Single-Use Medical Devices and the Food
and Drug Administration's Non-Enforcement of the Food, Drug, and Cosmetic Act
> Regulatory and Legal Implications of Reprocessing and Reuse of Single-Use Medical Devices
> An Assessment of the Regulations on Medical Devices in the European Union

The Importance of International Activities to the Work of the Food and Drug Administration's Center for Food Safety and Applied Nutrition
Author: Joseph A. Levitt & H. Michael Wehr
Issue: 56 Food and Drug Law Journal 1-10 (2001).

The new importance of the international sector (i.e., ensuring the safety of food in international trade, meeting trade agreement obligations, responding to the needs of other countries) has changed the way the Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition (CFSAN) does business. International engagement is an essential component of our work. CFSAN's Affirmative Agenda for International Activities, which is an action agenda, articulates the Center's international priorities. Key elements for the Affirmative Agenda include international activities of the Food Safety Initiative (FSI) and the work of the Codex Alimentarius Commission. As part of the FSI, FDA has recognized the need for a far greater foreign presence, rather than relying on surveillance at the U.S. border. CFSAN FSI international activities, focused on foods of significant import volume where consumer protection concerns are the highest, involve foreign food safety assessments, technical cooperation, and enhanced compliance activities. Codex work, especially the development of Codex standards and guidelines that have public health significance, is a high CFSAN priority. FDA, currently engaged with 19 of 21 Codex committees and task forces, is committed to continuing and strengthening its work in Codex. The Center's Affirmative Agenda for International Activities will continue to be the vehicle that will be used to prioritize and communicate its work in the international field.

Reflections on Delegation in the Chevron Era
Author: Royce C. Lamberth
Issue: 56 Food and Drug Law Journal 11-18 (2001).

Based on a speech given at FDLI's December 12, 2000 seminar, "Hatch-Waxman: Past, Present, & Future," this article offers Judge Lamberth's perspective on how the judiciary's current method of reviewing administrative regulations affects the democratic principles that are the foundation of our system of government. Judge Lamberth also explores the resurgence of the nondelegation doctrine and what impact this may have in the future. The article concludes with a personal note describing Judge Lamberth's recent experience presiding over the case of Washington Legal Foundation v. Henney.

Protecting the Balance of Hatch-Waxman: Understanding the Industry's New Dynamics
for the 21st Century
Author: Ralph G. Schroeder & Paul Papas
Issue: 56 Food and Drug Law Journal 19-26 (2001).

When the Drug Price Competition and Patent Term Restoration Act (also known as Hatch-Waxman) was enacted over 17 years ago, it helped to establish a balance between consumers' needs for lower priced drugs and the pharmaceutical industry's need for new innovation. Since Hatch-Waxman's initial enactment, the healthcare industry has undergone many changes. This article examines potential scientific advancements in the 21st century and how they will affect the pharmaceutical industry. It also discusses how scientific advancements will change the pharmaceuticals marketplace and how that will affect the overall healthcare system. Furthermore, this article addresses how Hatch-Waxman can be reformed to provide a supportive regulatory, legal, and business environment that will allow the pharmaceutical industry to continue its progress in the discovery and development of new medicines.

Guidelines on Gifts to Physicians From Industry: An Update
Author: The Council on Ethical and Judicial Affairs of the American Medical Association
Issue: 56 Food and Drug Law Journal 27-40 (2001).

In December 1990, the American Medical Association's (AMA's) House of Delegates adopted guidelines on Gifts to Physicians from Industry, which first appeared in the Code of Medical Ethics in 1992. A full length report, which provided the rationale for the recommendations, and also provided detailed answers to a number of requests for clarifications, was published in the Journal (47 Food & Drug L.J. 445 (1992)). Those clarifications were disseminated widely and served to provide clearer guidance to physicians and industry in determining appropriate gifts to physicians and subsidies for educational activities. Over the years, the Council on Ethical and Judicial Affairs (CEJA) has continued to provide specific answers to requests it receives asking for clarifications. This article provides the official AMA guidelines, first issued in 1990, the original CEJA report, and the most up-to-date clarifications on the guidelines.

WLF and the Two-Click Rule: The First Amendment Inequity of the Food and Drug Administration's Regulation of Off-Label Drug Use Information on the Internet
Author: Shane M. Ward
Issue: 56 Food and Drug Law Journal 41-56 (2001).

Because the Food and Drug Administration (FDA) does not regulate the practice of medicine, it does not regulate the prescribing of drugs for off-label uses. FDA, however, does have the authority to regulate manufacturers' promotion of off-label uses of approved drugs. This article addresses the bodies of law related to off-label use and discusses the significant changes brought on by the First Amendment. These changes were reflected in a series of federal court cases, most importantly, Washington Legal Foundation v. Henney. The district court ruled that off-label use information disseminated by the product sponsor, though commercial, is deserving of some First Amendment protection. This protection created "safe harbors," which proved problematic when applied to the Internet as a means for information dissemination. The Internet is not protected by the "safe harbor" and is subject to more regulation. This article explores the implications of the "safe harbor" and also explores the potential for the use of the Internet within an applied paper-oriented regulatory regime.

Going 90 in a 55 M.P.H. Speed Zone: Reprocessing of Used Single-Use Medical Devices and the Food and Drug Administration's Non-Enforcement of the Food, Drug, and Cosmetic Act
Author: Kurt R. Karst
Issue: 56 Food and Drug Law Journal 57-76 (2001).

The practice of reprocessing used single-use medical devices has grown significantly over the past 20 years, despite the added risks of compromised sterility and decreased functionality. Manufacturing a reprocessed used single-use medical device changes its intended use from single-use to multiple-use, thereby requiring the Food and Drug Administration's (FDA's) approval or clearance under the Food, Drug, and Cosmetic Act (FDCA). Simultaneous with the growth of reprocessing, FDA increasingly has enforced the device requirements of the FDCA on reprocessors; however, FDA has used its enforcement discretion to not enforce fully the premarket submission requirements of the FDCA. Although FDA's recently published guidance document represents a significant advance by requiring premarket submission for most reprocessed single-use devices, it does not require premarket submissions for all reprocessed single-use devices. To fulfill its mandate to protect patient health, and to ensure regulatory equity and uniformity, FDA must fully enforce the premarket submission requirements of the FDCA against reprocessed used single-use medical devices.

Regulatory and Legal Implications of Reprocessing and Reuse of Single-Use Medical Devices
Author: Emil P. Wang
Issue: 56 Food and Drug Law Journal 77-98 (2001).

Single-use medical devices (SUDs) increasingly have been reprocessed and reused by various entities in an effort to cut costs. This practice has been criticized as having an adverse impact on public health, from exposing patients to potentially infectious substances to patient injuries due to improper reprocessing techniques. Reprocessors of SUDs, such as hospitals and third-party reprocessors, historically have not been subject to regulatory oversight by the Food and Drug Administration (FDA). FDA recently has issued a proposed regulatory strategy that will subject reprocessors of SUDs to the same regulations that currently apply to medical device original equipment manufacturers, including premarket and postmarket requirements. In addition to FDA regulatory requirements, reprocessors also may be subject to potential legal liability resulting from patient injuries associated with this practice, ranging from strict liability theories, negligence, breach of warranty, and intellectual property claims. Therefore, reprocessors need to carefully balance their regulatory and legal responsibilities with the economic benefits from reusing SUDs in order to minimize their liabilities. This article provides an analysis of the regulatory requirements and legal issues, and highlights relevant ideas that reprocessors should consider in their reprocessing practices.

An Assessment of the Regulations on Medical Devices in the European Union
Author: Sharon Frank
Issue: 56 Food and Drug Law Journal 99-122 (2001).

This article provides an outline of the laws adopted for the marketing of medical devices in the European Union (EU). One objective of the EU medical device legislation relates to the European Community's commerce and economy, specifically the prohibition on restricting the free movement of medical devices in the EU. The article discusses the controversial, although not yet effective, premarket approval process in France for high-risk devices. Recently, a court upheld the French registration regime for in vitro diagnostic devices, even though it deviates from Community law. The article concludes with a discussion about whether an empirical study of all Member States should be conducted to determine whether the system sets the standards Member States need.