FDLI Publications: Food and Drug Law Journal 55-2

Volume 55 Issue 2

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> Update on the Center for Devices and Radiological Health
> The Safety of Genetically Modified Soybeans: Evidence and Regulation
> Data and Marketing Exclusivity for Pharmaceuticals in the European Community
> Global Harmonization of Regulatory Requirements for Premarket Approval of Autologous Cell Therapies
> Physician Modification of Legally Marketed Medical Devices:
Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act
> You Say Zantac, I Say Xanax: A Critique of Drug Trademark Approval and Proposals for Reform
> FDA Regulation of Internet Pharmaceutical Communications: Strategies for Improvement

Update on the Center for Devices and Radiological Health
Author: Elizabeth D. Jacobson
Issue: 55 Food and Drug Law Journal 185-192 (2000).

This article analyzes important issues facing the Center for Devices and Radiological Health (CDRH). Topics such as premarket review performance, improvements in science, "leveraging" agency resources, and increasing communication are discussed. The article concludes with a discussion of the current challenges facing CDRH.

The Safety of Genetically Modified Soybeans: Evidence and Regulation
Author: Steven H. Yoshida
Issue: 55 Food and Drug Law Journal 193-208 (2000).

Genetically modified foods (GMFs) have generated a great deal of controversy. Among other criticisms, GMFs are considered potentially unsafe to eat. This paper reviews data on one particular GMF, the Roundup Ready soybean. Studies by Monsanto showed that soybeans developed through genetic engineering are similar to non-engineered soybeans in terms of composition, use as animal feed, and safety. Thus, genetically engineered soybeans appear to be equivalent to non-engineered soybeans. Other consumer concerns not addressed by these published studies include possible tryptophan toxicity, allergenicity, generation of antibiotic resistance in gastrointestinal bacteria, and general uncertainties with transgenic technology. Available information suggests that these problems can be minimized. For both GMFs and non-GMFs, however, scientific certainty and absolute proof of safety for all consumers cannot be guaranteed. As is always the case, public acceptance of these products must be based on a balancing of risks and benefits.

Data and Marketing Exclusivity for Pharmaceuticals in the European Community
Author: Richard F. Kingham & Grant H. Castle
Issue: 55 Food and Drug Law Journal 209-224 (2000).

Most industrialized countries now recognize that data and marketing exclusivity are an important incentive to innovation in the pharmaceutical sector—one that patent protection does not always provide. The European Community (EC) has adopted a number of measures to provide periods of data or marketing exclusivity for pharmaceutical products, particularly in its legislation governing abridged marketing authorization applications (the EC equivalent of abbreviated new drug applications) and medicinal products (orphan drugs) for rare diseases.

The existing rules on abridged applications remain deficient in significant respects, despite more than thirteen years of judicial and regulatory clarification. Many important issues are still undecided, and the authors assert that the key question of whether to provide data exclusivity for new uses of old products has been decided incorrectly. The recent orphan drug legislation is better than the provisions on abridged applications, but important issues are yet to be resolved.

Global Harmonization of Regulatory Requirements for Premarket Approval of Autologous Cell Therapies
Author: Shane M. Ward
Issue: 55 Food and Drug Law Journal 225-244 (2000).

A comprehensive, globally harmonized system for the regulation of autologous cell therapies (ACTs) must be implemented in the near future. The current U.S. and international laws, regulations, and guidelines relating to ACTs weave an effectively impenetrable web of requirements barring efficient global commercialization of these products. The task of creating a valid harmonized guideline for ACTs is complicated by the lack of a complete model. To demonstrate the need for a comprehensive harmonized guideline, this article will: 1) define ACTs and identify the regulatory difficulties they present; 2) summarize the current regulatory schemes utilized by the United States, EU, and Japan, and identify their shortcomings; and 3) demonstrate the feasibility of creating an internationally harmonized guideline using the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) mechanism.

Physician Modification of Legally Marketed Medical Devices:
Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act
Author: John J. Smith
Issue: 55 Food and Drug Law Journal 245-254 (2000).

Clinical circumstances and good medical practice occasionally require that physicians modify legally marketed devices for patient use. Such modification raises complex regulatory issues under the Federal Food, Drug, and Cosmetic Act. These issues turn on the degree of modification, its purpose, and any activities taken to market the modified product.

Where a physician makes only minor modifications to a product, such that there is no significant alteration of the device's safety and effectiveness, there are likely no federal regulatory implications. Should modifications significantly alter safety and effectiveness, the physician has created, in essence, a new device, and his or her underlying purpose in making the modification becomes crucial. If the modification is undertaken primarily to provide patient treatment, it is likely that the activity would fall within the practice of medicine doctrine or custom device exemption. In either case, it is unlikely that the physician would face federal regulatory consequences.

A physician who significantly alters a legally marketed product cannot engage in activities that could be seen as marketing that modified device without risk of violating federal law. Though what actually constitutes marketing is fact-specific, treating large numbers of patients, actively advocating treatment using the modified product, and selling the modified device to other practitioners could all be seen as evidence of marketing.

You Say Zantac, I Say Xanax: A Critique of Drug Trademark Approval and Proposals for Reform
Author: Danielle A. Gentin
Issue: 55 Food and Drug Law Journal 255-268 (2000).

This article argues for the systematic reform of the current method of approving trademarks for pharmaceuticals. In particular, the article examines the inadequacies of the process for drug trademark approval from the perspectives of the Patent and Trademark Office, the Food & Drug Administration (FDA), healthcare workers, and the consuming public. After exploring various proposals for reform, the paper concludes that FDA should institute mandatory procedures to combat the ever-increasing confusion generated by today's lexicon of medications.

FDA Regulation of Internet Pharmaceutical Communications: Strategies for Improvement
Author: Emilé L. Loza
Issue: 55 Food and Drug Law Journal 269-292 (2000).

This article calls into question the Food and Drug Administration's (FDA's) position on the regulation of prescription drug marketing on the Internet. It is a "point-in-time" look at the roles that consumers, healthcare providers, and pharmaceutical manufacturers play in the healthcare system, and it examines how the rise of the Internet has affected these roles. After defining FDA's position on Internet drug communication, the article presents a brief survey of a few Internet drug sites and identifies problems that have arisen due to FDA's approach to Internet regulation. Finally, the article proposes a strategic Internet action plan, calling upon FDA to reinvent its regulations to encompass the Internet; to implement interim stop-gap measures; and to envisage compelling future views as it proceeds.