Volume 53 Issue 1
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Table of Contents
> Toys and Confectionery—A Legally Hazardous
Combination?
> Toys and Confectionery—A Legally Compatible
Combination
> Remarks of the Lead Deputy Commissioner of
the Food and Drug Administration
> Managed Care Cost Containment Involving Prescription
Drugs
> Independent Prescribing Authority of Advanced
Practice Nurses: A Threat to the Public Health?
> How Should FDA Regulate Prescription Drug
Promotion on the Internet?
> Government Investigations in the Pharmaceutical
Industry: Off-Label Promotion, Fraud and Abuse, and False
Claims
> FDA, Off-Label Use, and Informed Consent:
Debunking Myths and Misconceptions
> Implications of FDA’s Proposal to Include
Foreign Marketing Experience in the Over-the-Counter Drug
Review Process
> Implications of International Drug Approval
Systems on Confidentiality of Business Secrets in the U.S.
Pharmaceutical Industry
> FDA and Mutual Recognition Agreements: Five
Models of Harmonization
> Food From Developing Countries: Steps to
Improve Compliance
> The Regulation of Foodstuffs With a Specific
Health Effect and Health Claims in Germany
> No "Killer Tomatoes": Easing Federal
Regulation of Genetically Engineered Plants
Toys and Confectionery—A Legally Hazardous
Combination?
Authors: John S. Eldred & Stuart M. Pape
Issue: 53 Food and Drug Law Journal 1-8 (1998)
Prompted by recent publicity surrounding the market introduction, and subsequent withdrawal, by Nestlé USA of a spherical confectionery product enclosing an inedible plastic ball and toy, this article assesses and ultimately rejects the Food and Drug Administration’s (FDA’s) authority to permit the marketing of these types of products based solely on a finding that a given product is safe. The Federal Food, Drug, and Cosmetic Act expressly prohibits as adulterated any confectionery product imbedded with a nonfunctional, nonnutritive object. Because FDA has found in several previous instances that toys imbedded in chocolate are of no practical functional value to the confectionery, a regulation based solely on the safety of such products that purports to allow marketing would be contrary to the Act and beyond FDA’s authority. Thus, such a combination toy and confectionery product is adulterated and may not be marketed lawfully unless and until Congress amends the Act.
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Toys and Confectionery—A Legally Compatible Combination
Authors: Fred H. Degnan & Steven B. Steinborn
Issue: 53 Food and Drug Law Journal 9-15 (1998)
In 1997, Nestlé USA marketed "Magic™," a product that consisted of a toy figure encapsulated inside a large flexible plastic ball that, in turn, was surrounded by a hollow milk chocolate outer shell wrapped in foil and packaged in a cardboard box. This article addresses the legal issues presented by the marketing of this product. On the basis of the factual record established, the article determines that characterizing the marketing of Nestlé Magic as unlawful would not only be at odds with the literal language of the Federal Food, Drug, and Cosmetic Act, but also with how the Food and Drug Administration (FDA) has chosen to enforce the Act. The article focuses on the history, language, and interpretations of section 402(d) of the Act and its proscription against nonnutritive objects completely or partially imbedded in a confectionery. The authors of this article conclude that Nestlé Magic does not fall within the scope of section 402(d) and that Nestlé’s marketing of this product addressed and allayed the fundamental concerns of Congress and FDA expressed in section 402(d).
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Remarks of the Lead Deputy Commissioner of the Food and Drug Administration
Author: Michael A. Friedman
Issue: 53 Food and Drug Law Journal 19-23 (1998)
This past year has been a time of continued progress and consolidation of recent performance gains even in the face of steadily increasing workloads. These dramatic performance improvements have raised the expectations that both Congress and the public have for the Food and Drug Administration (FDA). With passage of the FDA Modernization Act, Congress reauthorized user fees for the review of new drugs and biologics. This will help to ensure the agency’s continued high performance. Nevertheless, FDA will face several challenges in the coming years. It is not clear that the agency will be able to continue the kinds of performance improvements that it has produced in the past if the FDA’s budget remains essentially flat.
In 1998, FDA will focus on special projects such as the National Food Safety Initiative and implementation of its tobacco regulations, even as the agency focuses on revitalizing and enhancing its scientific base and searches for a permanent chief science officer. The public has a vested interest in FDA’s health and vitality. While FDA is evolving, its commitment to traditional public health values remains unchanged.
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Managed Care Cost Containment Involving Prescription Drugs
Author: American Medical Association Council on Ethical and Judicial Affairs
Issue: 53 Food and Drug Law Journal 25-34 (1998)
In this report, the American Medical Association’s Council on Ethical and Judicial Affairs addresses the efforts by managed care plans to limit the cost of prescription drugs. Emphasis is placed on the importance of designing such efforts in ways that do not compromise patient welfare or the integrity of the patient-physician relationship. As managed care plans strive to meet the needs of society to restrain the growth of health care costs and to allocate health care fairly among different patients, the physician’s duty of loyalty to patients may be unduly compromised. Prescribing practices is one area of managed care in which physicians have encountered financial restraints. Formularies, limited lists of approved pharmaceuticals, are the most prevalent means of containing drug costs and are utilized by most managed care plans. To ensure optimal patient care, the Council offers various ethical requirements for formulary creation and management.
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Independent Prescribing Authority of Advanced Practice
Nurses: A Threat to the Public Health?
Author: James L.J. Nuzzo
Issue: 53 Food and Drug Law Journal 35-46 (1998)
Many state governments, as well as the Clinton Administration, have sought to provide advanced practice nurses (APNs) with the same access to the pharmacopoeia as that enjoyed by board certified subspecialist physicians. Supporters of such access, however, have failed to consider carefully the public health consequences of their actions. The Food and Drug Administration (FDA) has legitimate concerns over the off-label use of pharmaceuticals by physicians, because of the lack of rigorous continuing pharmacological education to allow for appropriate independent decisionmaking. Therefore, expanding prescribing authority to APNs, who lack substantial formal education in pharmacology and other basic medical sciences, is troubling. This article argues that FDA should use its significant regulatory power to curb the expansion of prescribing authority to APNs unless appropriate safeguards are instituted.
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How Should FDA Regulate Prescription Drug Promotion on the Internet?
Author: David W. Opderbeck
Issue: 53 Food and Drug Law Journal 47-61 (1998)
The current scheme for regulating prescription drug labeling and advertising was developed in a world in which information was centralized, static, and one-dimensional. The world of the Internet is different. Information is now instantly, globally accessible, and anyone with a computer and a modem can become a publisher. The question of how, or whether, the Food and Drug Administration (FDA) should regulate prescription drug promotion in this new context is a pressing one.
This article traces the development of the Internet from its academic roots to its current status as a ubiquitous commercial and cultural force. The article then discusses the suitability of current FDA regulations concerning prescription drug promotion, using two very different drug-related web sites as examples. Finally, the article summarizes the three dominant regulatory models for Internet content proposed at a recent FDA hearing — the "wild frontier," "GMP," and "status quo" models — and provides some suggestions for a new hybrid model.
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Government Investigations in the Pharmaceutical Industry:
Off-Label Promotion, Fraud and Abuse, and False Claims
Authors: Paul E. Kalb & I. Scott Bass
Issue: 53 Food and Drug Law Journal 63-70 (1998)
This article focuses on government investigations in the pharmaceutical industry, looking not only at investigations under the Federal Food, Drug, and Cosmetic Act (such as off-label promotion), but also at those relating to Medicare fraud and abuse and Medicare rebates. It describes how investigations in all of these areas can be triggered by relatively common industry practices such as grant-giving, and discusses the current climate in which such investigations are being initiated. The article also explores the reasons underlying the recent increase in enforcement activity and addresses the high cost of noncompliance. Finally, it offers a number of practical suggestions about steps manufacturers can — and should — take to minimize their legal exposure while continuing to focus on their business goals.
Food and Drug Law Journal article cited in U.S. Supreme Court decision
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FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions
Authors: James M. Beck & Elizabeth D. Azari
Issue: 53 Food and Drug Law Journal 71-104 (1998)
This article addresses whether Food and Drug Administration (FDA) regulatory status is properly an element of informed consent. The article briefly explains how drugs and devices obtain an FDA regulatory status. It then addresses the legal, ethical, and practical position of off-label use of FDA regulated products, and the limits on FDA’s regulation of the practice of medicine. Misconceptions that off-label use is necessarily "experimental" or "investigational" are debunked. The article discusses how FDA regulatory status is, and should be, separate from the common law of informed consent, and examines the informed consent law of several states in depth. Finally, the article discusses how the 1997 FDA Modernization Act can be expected to affect off-label use and tort claims involving such use.
Food and Drug Law Journal article cited in U.S. Supreme Court decision.
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Implications of FDA’s Proposal to Include Foreign Marketing Experience
in the Over-the-Counter Drug Review Process
Author: Robert G. Pinco
Issue: 53 Food and Drug Law Journal 105-122 (1998)
The Food and Drug Administration’s (FDA’s) October 3, 1996 advanced notice of proposed rulemaking to amend the agency’s over-the-counter (OTC) drug regulations would expand the OTC review process to include foreign drug products that have an established marketing history (material time/material extent) of safe and effective usage. Historically, the OTC drug review process has been open only to drug products that were on the U.S. market as of 1972. This policy effectively has denied U.S. consumers access to safe and effective products that have an established history of use in other countries. The agency’s proposal to broaden the OTC eligibility criteria is a positive step that would benefit the pharmaceutical industry and consumer alike. FDA’s current proposal, however, would establish more rigorous standards for foreign products than the standards applied to domestic products. The author of this article maintains that in amending the eligibility criteria for the OTC review, FDA should implement a policy that treats foreign products with foreign marketing data similarly to domestic products already included in the OTC review.
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Implications of International Drug Approval Systems on Confidentiality
of Business Secrets in the U.S. Pharmaceutical Industry
Author: James T. O’Reilly
Issue: 53 Food and Drug Law Journal 123-132 (1998)
Serious complications face the U.S. innovative drug industry as a result of the increased multigovernment sharing of confidential business information by the Food and Drug Administration (FDA). Mutual recognition agreements may benefit U.S. trade, but such agreements can create an opening through which important proprietary data may "leak" to foreign competitors of the U.S. pharmaceutical industry, unless FDA rules and procedures are updated.
This article offers a general discussion from a U.S. perspective on the impact of FDA disclosure policy on export sales and foreign license or sales income of innovative U.S. drugs and medical devices. Innovative companies are vulnerable to economic loss if their data on new pharmaceutical entities is disseminated without adequate trade secret protection. This article seeks to raise awareness on these issues and to suggest defensive measures.
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FDA and Mutual Recognition Agreements: Five Models of Harmonization
Author: Richard A. Merrill
Issue: 53 Food and Drug Law Journal 133-137 (1998)
This article discusses the legal steps the Food and Drug Administration (FDA) may be required to take to implement, i.e., to domesticate, the agreements it enters into with other countries. The challenging question is no longer whether FDA has authority to enter such agreements, for the FDA Modernization Act of 1997 has answered that in the affirmative. Rather it is how may the agency translate its commitments into domestic law and practice. The article briefly reviews the pertinent institutional relationships within the executive branch of the U.S. government, and goes on to offer the author’s framework for analyzing the procedural steps FDA must take to implement international agreements. This framework is built around five models, which vary as to issues of legal authority and administrative process.
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Food From Developing Countries: Steps to Improve Compliance
Author: Linda R. Horton
Issue: 53 Food and Drug Law Journal 139-171 (1998)
Developing countries seeking to expand their exports often turn to food exports and seek to market these products in developed countries such as the United States. To be successful, developing countries must overcome an array of obstacles, including the need to comply with food safety and other requirements of the importing country. This article discusses how compliance with international food norms and national food laws benefits exporting and importing countries, what trends in food trade influence measures to deal with food problems, and what categories of controls are available to deal with good products offered for importation. The article concludes by outlining several suggested steps that can be taken to improve the likelihood of acceptability of food offered for importation.
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The Regulation of Foodstuffs With a Specific Health Effect and Health Claims in Germany
Author: Stefan Hermle
Issue: 53 Food and Drug Law Journal 173-179 (1998)
This article focuses on the German regulation of the advertising of foodstuffs with a specific effect on health. By prohibiting restrictively and generally any disease-related claims, the German Act of Foodstuffs and the Goods of Daily Use (Lebensmittel-und Bedarfsgegenständegesetz) makes it very difficult for producers of foodstuffs to advertise specific health effects.
The German regulatory system lacks a legal basis for characterizing foodstuffs with a specific effect on health and fails to provide for the need to advertise the effects of such products. Therefore, this article introduces concepts taken from the British Food & Drink Federation, which define such foodstuffs and state principles for advertising based on protecting the consumer against misleading advertising. The article also assesses the role of the Directive of the European Communities on labelling, presentation, and advertising of foodstuffs to the ultimate consumer (79/112/EC), which overrules national laws within the European Union or determines how such national laws may be interpreted.
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No "Killer Tomatoes": Easing Federal Regulation of Genetically Engineered Plants
Author: Judith E. Beach
Issue: 53 Food and Drug Law Journal 181-191 (1998)
This article discusses the regulation of the use of genetically engineered organisms by the three federal organizations that have significant roles in regulating such use: the U.S. Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency. In response to the public’s fear that genetic engineering of plants somehow would harm the environment, these agencies promulgated strict regulations and established policies to provide specific guidelines for such regulation. Based on extensive regulatory review and testing, however, these regulatory organizations determined that there are no risks to the environment and are liberalizing their regulations. Indeed, in contrast with the policies of the European Union, the U.S. government considers genetically engineered crops to be identical to traditional crops so that, unless specific safety issues are raised, special labeling of genetically engineered foods is not required.
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