FDLI Publications: Food and Drug Law Journal 53-3

Volume 53 Issue 3

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> Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices
> Black Box Warnings in Prescription Drug Labeling: Results of a Survey of 206 Drugs
> Dietary Supplements: Background for Dialogue Between the Industry and the Medical Profession
> So You Want to Market a Food and to Make Health-Related Claims—How Far Can You Go? What Rules of Law Will Govern the Claims You Want to Make?
> Civil and Criminal Liability Associated With Food Recalls
> FDA at War: Securing the Food That Secured Victory
> ORA's Role at FDA Headquarters and in the Field for Product Recalls
> Corporate Compliance Programs: A Shield Against Criminal Liability
> A Plan that Establishes a Framework for Achieving Mutual Recognition of Good Manufacturing Practices Inspections
> The Impact of International Trade Agreements on U.S. Food Safety and Labeling Standards
> The Marketing of Foodstuffs in France
> FDA Regulation of Genetic Testing: Institutional Reluctance and Public Guardianship

Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices
Authors: Janice M. Hogan & Thomas E. Colonna
Issue: 53 Food and Drug Law Journal 385-402 (1998)

This article discusses the reuse and reprocessing of single-use medical devices. Specifically, this article reviews the economic forces associated with medical device reprocessing, the Food and Drug Administration's current policies regarding single-use medical device reuse and reprocessing, the legal framework for assessing products liability for industrial equipment reprocessors generally, and an analysis of these general principles as applied to the reprocessing of single-use medical devices. The review concludes with recommendations to minimize potential liability by outsourcing disposable device reprocessing, establishing validation standards, and providing adequate training and communication to employees.

Black Box Warnings in Prescription Drug Labeling: Results of a Survey of 206 Drugs
Authors: Judith E. Beach, Gerald A. Faich, F. Gail Bormel & Frank J. Sasinowski
Issue: 53 Food and Drug Law Journal 403-412 (1998)

In any prescription drug labeling, the Food and Drug Administration (FDA) may require cautionary information to be displayed prominently in a boxed warning, or a "black box" warning. In 206 package inserts in the 1995 Physicians' Desk Reference, the authors found that such black box warnings generally highlighted risk(s) of clinical significance requiring the judgment of the medical practitioner to evaluate. FDA requires such warnings for serious or life-threatening drug-associated risks that are well-established and well-defined, supported in nearly all cases by the incidence of such events in controlled clinical trials, and/or based on compelling patterns of postmarketing reporting.

Dietary Supplements: Background for Dialogue Between the Industry and the Medical Profession
Author: Arnold I. Friede
Issue:53 Food and Drug Law Journal 413-420 (1998)

The Dietary Supplement Health and Education Act of 1994 (DSHEA) reflects a deliberate congressional decision, rooted in the factors that impelled its enactment, to omit Food and Drug Administration (FDA) premarket review and approval from the regulatory scheme. By contrast with the statutory requirements for approval of new drugs and food health claims, the dietary supplement regime is intended to be largely self-executing; manufacturers simply are required to notify FDA about actual and proposed marketplace activity. The agency bears the burden to take affirmative regulatory action if it believes statutory criteria are not satisfied. FDA demonstrated its discomfort with this new framework in its recent proposal to define safe harbor structure/function claims for dietary supplements, and in its interpretation as to when prior marketing of an article as a new drug conclusively precludes its eligibility for dietary supplement status. With this agency skepticism and absent a discrete FDA premarket review and approval mechanism, the industry and the medical profession need to collaborate to develop information exchange mechanisms in order to provide a basis for assuring healthcare consumers of the integrity and reliability of dietary supplements.

So You Want to Market a Food and to Make Health-Related Claims—
How Far Can You Go? What Rules of Law Will Govern the Claims You Want to Make?
Author: Stephen H. McNamara
Issue: 53 Food and Drug Law Journal 421-436 (1998)

This article provides an overview of the regulatory rules that govern claims of health-related benefits made in food labeling or advertising, including not only conventional food products, but also medical foods, dietary supplements, "functional foods," "nutraceuticals," and other products that a company wants to market as a food, and not as a drug. All foods are subject to the regulatory rules applicable to use of health-related claims in food labeling and advertising described herein. The article also discusses recent developments, including the FDA Modernization Act enactment, and proposed rules to distinguish "disease claims" from certain "structure/function claims" published recently by the Food and Drug Administration (FDA). The article stresses the importance of distinguishing between labeling and advertising claims, and of avoiding the pitfalls of claims to cure, mitigate, treat, or prevent disease. The article then identifies health-related claims that may be used in food labeling and advertising. Although the rules are complex and sometimes require FDA approval of a particular claim, there are types of health-related claims that may be made for foods without triggering drug status.

Civil and Criminal Liability Associated With Food Recalls
Author: John M. Packman
Issue:53 Food and Drug Law Journal 437-452 (1998)

This article provides an overview of the civil and criminal liability that a food producer can incur in connection with a recall. The article asserts that a food producer's failure to recall a violative product can increase the company's potential civil and criminal liability. It also asserts that, under the right circumstances, undertaking a recall can help to limit the company's liability, even though the product recall will attract attention from civil plaintiffs and state and federal law enforcement authorities.

On discovering one of its food products to be violative, a company frequently becomes concerned that a recall will draw the attention of both regulators and potential plaintiffs to the problem. Failure to recall, however, is more likely to increase potential liability, rather than to decrease it.

FDA at War: Securing the Food That Secured Victory
Author: James Robert Dean, Jr.
Issue: 53 Food and Drug Law Journal 453-512 (1998)

World War II was a crucial and unique period in the Food and Drug Administration's (FDA's) history. Soon after receiving a greatly expanded mandate through the 1938 Federal Food, Drug, and Cosmetics Act the agency had to deal with the tremendous increase in production by regulated industries and with the extensive involvement by other government agencies in the wartime economy. This article describes how FDA met these challenges during the war, and further suggests that FDA's wartime experience has influenced the subsequent development of American administrative practice to a much greater extent than generally has been acknowledged.

ORA's Role at FDA Headquarters and in the Field for Product Recalls
Author: Sandra Nowlin Whetstone
Issue: 53 Food and Drug Law Journal 513-516 (1998)

The Associate Commissioner for Regulatory Affairs (ACRA) heads the Food and Drug Administration's (FDA's) Office of Regulatory Affairs (ORA) and establishes the agency's general recall policy and procedures. The Office of Enforcement, Division of Compliance Management and Operations Recall Operations Staff (OE/DCMO/ROS) within ORA provides staff support to the ACRA's office with respect to recall policies and procedures, and serves as FDA's focal point for information, advice, and direction regarding the field aspects of all recalls. The staff works closely with FDA Centers during each significant recall with the goal of maintaining agency-wide consistency in policy and procedures. The OE/DCMO/ROS also maintains FDA's recall database and evaluates the overall effectiveness of recall activities.

Corporate Compliance Programs: A Shield Against Criminal Liability
Author: Steven M. Kowal
Issue:53 Food and Drug Law Journal 517-526 (1998)

Business continues to be a prime target for government enforcement agencies. Corporations particularly are vulnerable because they are responsible for their employees' conduct in many instances, even where that conduct defied express direction. Individuals operating in highly regulated industries are subject to the same threat. A responsible relationship to a violation can suffice for a conviction, even without participation in the violative conduct. In this environment, prevention is the best defense, demanding a corporate culture that requires and rewards ethical and legal conduct, and that deters and punishes violative conduct. Internal compliance program are important to the achievement of these goals.

Corporate compliance programs, if operated effectively, can produce tangible benefits in the event of a criminal investigation, and can help reduce certain civil liability. Moreover, in the near future, such programs may be necessary to comply with the duty of care imposed on corporate directors and managers. These potential benefits will be realized, however, only where the program complies with Federal Sentencing Guidelines and meets certain minimum requirements to demonstrate that the program is effective.

A Plan that Establishes a Framework for Achieving Mutual Recognition
of Good Manufacturing Practices Inspections
Author: Linda R. Horton & Kathleen E. Hastings
Issue: 53 Food and Drug Law Journal 527-536 (1998)

The Food and Drug Administration Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to "make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections" no later than May 20, 1998. The agency published this plan on its website on May 20, 1998. The plan focuses on FDA's primary role to maintain and strengthen domestic public health safeguards, and strives toward a common international ground as to regulatory systems (including good manufacturing practices (GMP) inspections), criteria for the collection and assessment of inspection information, and appropriate enforcement procedures.

The plan discusses the types of international agreements or arrangements into which the agency enters with other countries, outlines FDA's policy on agreements with foreign regulatory counterparts, reviews current agreements and activities, establishes a framework for mutual recognition agreements with other countries on GMP inspections, outlines approaches for confidence-building activities with foreign countries, and specifies current FDA priorities in this area.

The Impact of International Trade Agreements on U.S. Food Safety and Labeling Standards
Author: Bruce A. Silverglade
Issue: 53 Food and Drug Law Journal 537-542 (1998)

Food and Drug Administration and U.S. Department of Agriculture food safety and labeling regulations are in danger of being weakened as a result of trade agreements that provide for the international harmonization of regulatory requirements. The Administration claims that international harmonization, as mandated by the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), helps to increase U.S. exports and will not lead to lower health and safety standards.

A review of recent actions by the Codex Alimentarius Commission, the United Nations affiliate charged with the harmonization effort, however, indicates that U.S. regulatory requirements are at risk. The Administration should conduct a policy review and make a firm commitment to place food safety standards ahead of increasing exports. The Administration also should revamp U.S. participation in Codex and seek SPS Agreement amendments that better protect the interests of American consumers in a safe and wholesome food supply.

The Marketing of Foodstuffs in France
Author: Nicole Coutrelis
Issue: 53 Food and Drug Law Journal 543-554 (1998)

The marketing of foodstuffs in France is largely governed by European law, which establishes general principles, such as the free movement of goods within the European Union (EU), as well as by specific regulations related to the food sector. In order to successfully market a product in France, however, it also is necessary to take into account French regulations, which derive from laws as well as from French tradition. Some related French regulations are codified in the recently issued Code de la Consummation (Consumer Code) while others are found in specific texts, in various Administration positions, and in case law.

Depending on its marketing strategy, a company must reasonably determine the category to which the product belongs, i.e., medicine or foodstuff, foodstuff for ordinary consumption or for particular nutritional uses, etc. This choice entails specific legal consequences as to procedural requirements and the product's composition and presentation, and when questions arise as to the conformity of French requirements to EU law, the latter must prevail.

FDA Regulation of Genetic Testing: Institutional Reluctance and Public Guardianship
Author: Anny Huang
Issue: 53 Food and Drug Law Journal 555-592 (1998)

In recent years remarkable advances in genetic research have made marketing genetic tests into a viable commercial enterprise. People, however, are concerned about genetic testing. While a consensus appears within reach regarding the privacy of genetic information, basic questions about regulating genetic tests themselves remain mired in complex theoretical and scientific controversies. The Food and Drug Administration (FDA), however, is the most logical and efficient choice as the regulatory actor. Ensuring public health safety in an age of new biological technologies will undoubtedly subject FDA to evolutionary pressures, but the novelty and complexity of genetic technology should not deflect the agency from its traditional goals and areas of oversight, nor should the use of innovative forms to deliver essentially commercial products.