FDLI Publications: Food and Drug Law Journal 55-1

Volume 55 Issue 1

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> Remarks of the Commissioner of Food and Drugs
> FDLI Futurist Subcommittee, FDLI Futurist Task Force Reports
> A Survey of Developments in Food and Drug Law from July 1998 to November 1999
> Medical Device Regulation in the United States and the European Union: A Comparative Study
> Resolving International Sanitary and Phytosanitary Disputes in the WTO: Lessons and Future Directions
> Modification and Consumer Information: Modern Biotechnology and the Regulation of Information
> Direct-to-Consumer Advertisements of Prescription Drugs
> The Orphan Drug Act: An Engine of Innovation? At What Cost?
> Abbott Laboratories Consent Decree and Individual Responsibility
Under the Federal Food, Drug, and Cosmetic Act
> DSHEA and Structure/Function Claims for Animal Feed
> An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation

Remarks of the Commissioner of Food and Drugs
Issue: 55 Food and Drug Law Journal 1-4 (2000).
Author: Jane E. Henney

The turn of the century is a good time to reflect on past accomplishments, and even more importantly, to examine our preparedness for the challenges that lie ahead. The Food and Drug Administration (FDA) has made considerable progress on the priorities articulated last year, including implementation of the Food and Drug Administration Modernization Act of 1997, strengthening FDA's science base, and pursuing initiatives relating to food safety, blood safety, and tobacco. Strengthening the agency's science base is particularly important because it plays a role in every part of FDA's decision making processes. Rapid changes in technology require that agency scientists keep abreast of new scientific advances in order to fulfill FDA's mission. Credibility, integrity, and independence are the underlying values that maintain and strengthen continued consumer confidence in the agency. While FDA's mission is not changing, the agency is focusing on ways to increase its ability to perform its duties as effectively and efficiently as possible.

FDLI Futurist Task Force Reports
Issue: 55 Food and Drug Law Journal 5-34 (2000).
Author: FDLI Futurist Subcommittee

Over the past year, the Food and Drug Law Institute's (FDLI's) Futurist Task Forces met to discuss what the next fifty years hold for food and drug law issues. This article is a collection of the reports presented at FDLI's 43rd Annual Educational Conference in Washington, D.C. (Dec. 16-17, 1999). The reports predict how the changing dynamics of the U.S. population will affect the regulation of food, human and animal pharmaceuticals, biologics, dietary supplements, and medical devices. The reports note that factors such as the increasing age of the population, the influx of more diverse ethnic populations, the greater availability of foreign foods, and the increase in consumer input in personal healthcare decisions are all modifying the dynamics of the U.S. population. The reports also emphasize the rapid development of scientific technology, which will lead to advancements in medical devices, dietary supplements, and pharmaceuticals. The members of the task forces predict that the Food and Drug Administration's (FDA's) role will change to respond to future public health concerns generated by scientific advancements and shifting demographics, so that consumer protection remains a high priority while allowing for technological innovation and advancement.

A Survey of Developments in Food and Drug Law from July 1998 to November 1999
Issue: 55 Food and Drug Law Journal 35-56 (2000).
Author: Nick Littlefield and Nicole R. Hadas

This article summarizes the developments in food and drug law during a period of profound change at the Food and Drug Administration (FDA) that will continue well into the new millennium. FDA's efforts to maximize its responsiveness to innovation associated with advances in biotechnology and biomedicine were coupled with the appointment of Dr. Jane E. Henney as Commissioner of Food and Drugs on November 30, 1998. In addition to implementing the "letter and spirit" of the Food and Drug Administration Modernization Act of 1997, Commissioner Henney has identified several priorities—including strengthening FDA's science base and ensuring food safety and the safety of the U.S. blood supply—that continue to shape FDA policy and developments. Judicial, administrative, and legislative developments over this time period are addressed in this comprehensive survey of food and drug law.

Medical Device Regulation in the United States and the European Union: A Comparative Study
Issue: 55 Food and Drug Law Journal 57-80 (2000).
Author: John Y. Chai

This article compares and contrasts medical device regulation in the United States and the European Union (EU). Further, it discusses the ongoing international efforts toward harmonization of national regulatory requirements for medical device regulations. The author analyzes the U.S. and EU systems based on factors such as history, the mission of regulatory schemes, the administrative structures, the test of marketability of a medical device, the device classification system, and the scope and emphasis of regulatory controls. The author also assesses the regulatory systems in meeting their goals, and the efficiency of the systems in reviewing medical devices. The last section discusses recent international efforts in harmonization of medical device regulations.

Resolving International Sanitary and Phytosanitary Disputes in the WTO: Lessons and Future Directions Issue: 55 Food and Drug Law Journal 81-104 (2000).
Author: Kevin C. Kennedy

Although the burden of proof of a violation of the SPS Agreement rests with the complaining World Trade Organization (WTO) member, WTO jurisprudence to date shows that that burden is a relatively low barrier to clear. This is not surprising. The WTO is first and foremost the premier international organization for the enforcement of rules designed to promote open trade, and only incidentally, an institution that enforces sanitary and phytosanitary standards.

Under the SPS Agreement, an international standard presumptively is valid, thereby placing a heavy burden of proof on a complaining WTO member. One strategy for any importing country to pursue is to leverage international standard-setting bodies for the adoption of international standards that meet that country's sanitary and phytosanitary standards.

In addition, the precautionary principle has not been a viable defense in WTO dispute settlement proceedings. The Appellate Body, although somewhat delphic in its pronouncements on this score, has signaled that the SPS Agreement will have to be amended and clarified in this connection if WTO members want to raise the precautionary principle as a legal defense in WTO dispute settlements.

Modification and Consumer Information: Modern Biotechnology and the Regulation of Information
Issue: 55 Food and Drug Law Journal 105-118 (2000).
Author: J. Howard Beales III

This article examines consumers' need for information about food products containing genetically modified organisms (GMOs). Despite the scientific consensus that biotechnology products do not pose unique risks, some consumers may seek to avoid such products. Various rationales for labeling may justify the provision of particular information, but offer little reason for a mandatory disclosure that a food is genetically modified. This article contends that if enough consumers are interested in avoiding GMOs, voluntary claims for products without GMOs will emerge. Unlike mandatory disclosures, voluntary claims place the costs of labeling on consumers who value the information, rather than those who are not interested. Costs of labeling include the costs of keeping genetically modified foodstuffs separate from traditional varieties, and information costs stemming from including excess information on food labels.

Direct-to-Consumer Advertisements of Prescription Drugs
Issue: 55 Food and Drug Law Journal 119-124 (2000).
Author: The Council on Ethical and Judicial Affairs of the American Medical Association

If used appropriately, direct-to-consumer (DTC) advertising has the potential to increase patient awareness about treatment options and enhance patient-physician communication. Advertising directly to the public educates patients, enabling them to better understand and participate in medical care. While this benefits the practice of medicine, such advertisements are beneficial only if they do not distort information and mislead patients. This article by the American Medical Association's Council on Ethical and Judicial Affairs suggests guidelines for physicians to ensure that DTC advertising does not lead to false expectations and does not undermine professional standards of informed consent.

The Orphan Drug Act: An Engine of Innovation? At What Cost?
Issue: 55 Food and Drug Law Journal 125-144 (2000).
Author: David Duffield Rohde

This article reviews the Orphan Drug Act's impact on innovation in the development of pharmaceutical products and applications, known as orphan drugs, for the treatment of rare diseases. Because an orphan drug's market is limited, industry concerns over the drug's profitability are considerable. Indeed, while the Act has led to the introduction of numerous products, some question remains as to whether its current regulatory scheme efficiently encourages market innovation and, if so, at what social and economic costs.

To address these issues, the article analyzes: 1) the Act's legislative history and underlying theory of regulation; 2) the orphan drug market conditions and FDA regulatory processes that existed prior to the Act's adoption; 3) the costs and benefits that the Act's market exclusivity provisions impose on orphan drugs and the impact those provisions have on new drug applications; 4) the market externalities, including tort liability, that affect orphan drug innovation; and 5) the Act's efficiency in bringing new products to the market.

The article concludes that while the Act has succeeded in both bringing orphan drugs to market and in providing treatment to those individuals suffering from rare diseases, it suggests that the Act could be changed to encourage innovation more efficiently, especially in terms of its market exclusivity provisions. While market exclusivity has been discussed and criticized in the context of "blockbuster" drugs, there is an absence of analysis concerning whether or not the Act's seven-year period strikes an appropriate balance between the need to incentivize innovation in orphan drugs, and the public benefit associated with a competitive market. Such analysis would provide a sound basis for adjusting the market exclusivity term to better balance the grant of a monopoly with the needs of society.

Abbott Laboratories Consent Decree and Individual Responsibility
Under the Federal Food, Drug, and Cosmetic Act
Issue: 55 Food and Drug Law Journal 145-150 (2000).
Author: Eric M. Blumberg

This article focuses on two matters. First, it describes the background, major provisions, and Food and Drug Administration (FDA) rationale for the recent Consent Decree of Permanent Injunction agreed to by Abbott Laboratories. Secondly, it explains, why FDA seeks to identify and hold individual defendants responsible in its enforcement cases, including injunctions.

DSHEA and Structure/Function Claims for Animal Feed
Issue: 55 Food and Drug Law Journal 151-160 (2000).
Author: Jeannie Perron and Eugene I. Lambert

Recent developments in the regulation of conventional foods and dietary supplements for humans provide a new basis for allowing the use in the labeling of feeds and dietary supplements for animals of the same types of "structure/function claims" that legally may be used on human products. In its 1999 "no objection letters" with respect to the new Benecol and Take Control vegetable oil spreads, the Food and Drug Administration tacitly agreed that the products' novel dietary ingredients, which had nontraditional functions, were "nutrients" or had "nutritive value," thereby significantly expanding the meaning of those terms. These expanded definitions arguably provide a mechanism by which animal feed manufacturers can include in the labeling of their products claims based on the nontraditional functions of new or known dietary ingredients, as well as provide functional information about well-recognized nutrients. This article examines the history and current issues involving the regulation of label claims on dietary supplements and conventional foods for humans, as well as the historical treatment of such claims on animal products, and argues that an expanding category of structure/function claims should be available for these animal products.

An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
Issue: 55 Food and Drug Law Journal 161-184 (2000).
Author: Suzanne White Junod

The 1938 Federal Food, Drug, and Cosmetic Act (FDCA) recognized as drugs those substances contained in the U.S. Pharmacopeia, the National Formulary, and the Homeopathic Pharmacopeia of the United States (HPUS). Although the legislative record is silent as to how the HPUS came to be recognized in the FDCA, it has been assumed that the provision was simply a concession to Royal Copeland, Senate sponsor of the FDCA. Evidence from the Copeland Papers, however, combined with a careful analysis of the evolution of the draft FDCA, support the idea that it could have been included in the earliest draft of the FDCA with the support of regulators who hoped to use it to prosecute fraudulent homeopathic drugs. Since 1938, the HPUS provision has created unanticipated regulatory challenges, especially following enactment of the 1962 Kefauver-Harris drug amendments, and institution of the agency's modern mandate to ensure the efficacy of both prescription and over-the-counter drugs.

Author Suzanne White Junod receives Thomson Prize for this Food and Drug Law Journal article