FDLI Publications: Food and Drug Law Journal 51-4

Volume 51 Issue 4

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> Remarks by the Commissioner of Food and Drugs at the Twentieth Anniversary Celebration of the 1976 Medical Device Amendments
> Remarks by the Honorable Paul G. Rogers at the Twentieth Anniversary Celebration of the 1976 Medical Device Amendments
> Federal Preemption of Common Law Tort Awards by the Federal Food, Drug, and Cosmetic Act
> Premarket Approval and Federal Preemption of Product Liability Claims in the
Wake of Medtronic, Inc. v. Lohr
> Medical Device Preemption After Medtronic, Inc. v. Lohr
> The FDA Export Reform and Enhancement Act of 1996: The FDA's New Extraterritorial Authority Over Labeling and Promotional Practices
> The New Drug Marketing: A Consumer Protection Perspective
> Teaching the Elephant to Dance: Privatizing the FDA Review Process
> FDA Rulemaking After the 104th Congress: Major Rules Enter the Twilight Zone of Review
> Legal Overview of Likely FDA Regulation of Internet Promotion
> The European Market for Food Products
> Globalization of a Food Processor

Remarks by the Commissioner of Food and Drugs at the Twentieth Anniversary Celebration
of the 1976 Medical Device Amendments
Author: David A. Kessler
Issue: 51 Food and Drug Law Journal 501-503 (1996)

This article is a transcription of Commissioner Kessler's remarks at the twentieth anniversary celebration of the Medical Device Amendments of 1976. Commissioner Kessler commended the Center for Devices and Radiological Health for the tremendous strides it has taken since the enactment of the Amendments in regulating medical devices to ensure that they are as safe and effective as possible. He reflected on all the changes that have occurred in device development and technology over the last twenty years and commended the Center for its ability to keep up with the advances, and concluded that the Center with its excellent staff and facilities would continue in the future to ensure the safety and effectiveness of devices utilized in the United States.

Remarks by the Honorable Paul G. Rogers at the Twentieth Anniversary Celebration
of the 1976 Medical Device Amendments
Author: Paul G. Rogers
Issue: 51 Food and Drug Law Journal 505-507 (1996)

This article comprises a short remembrance by Mr. Rogers of the 1976 Medical Device Amendments after twenty years. The reasons for the law’s passage and the basis for its formulation are set forth, as well as the basic philosophy that the least regulations to reasonably ensure safe and effective devices. The Center for Devices and Radiological Health in administering the Amendments has benefited the public and has helped build the Medical Device industry by ensuring that products sold are safe and effective.

Federal Preemption of Common Law Tort Awards by the Federal Food, Drug, and Cosmetic Act
Author: Michael K. Carrier
Issue: 51 Food and Drug Law Journal 509-611 (1996)

The states historically have been responsible for their citizens’ health, safety, and welfare through the exercise of their police powers. Yet prior to the Supreme Court’s recent decision in Medtronic, Inc. v. Lohr, many courts had held state common law tort awards involving medical devices were expressly preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The development of preemption case law demonstrates the states’ traditional role in protecting citizens’ health, safety, and welfare; the role states have played in regulating concurrently with the federal government; and the courts’ willingness to allow states to protect their citizens through state tort law even in areas regulated extensively by federal government. The Medical Device Amendments, construed in light of the Supreme Court’s 1992 decision in Cipollone v. Liggett Group, Inc. had been held by most courts to preempt common law tort awards. While the recent Lohr decision found none of the plaintiff’s claims expressly preempted under the Amendments, the Court left open the possibility that tort claims might not be found impliedly preempted through conflict with federal law in the future.

Premarket Approval and Federal Preemption of Product Liability Claims in the
Wake of Medtronic, Inc. v. Lohr
Author: Daniel G. Jarcho
Issue: 51 Food and Drug Law Journal 613-618 (1996)

The U.S. Supreme Court’s decision in Medtronic, Inc. v. Lohr has sparked significant interest because of its potential effects on the scope of product liability exposure in the medical device industry. Although the Supreme Court’s decision denied preemption of product liability claims involving a device cleared through the 510(k) premarket notification process, claims involving premarket approval (PMA) devices should be preempted under the Court’s analysis. The Lohr Court confirmed that in appropriate cases, the express preemption provision of the Medical Device Amendments of 1976 may bar common law product liability claims. In addition, the Court’s analysis supports the conclusion that the PMA requirements can preempt state law. Following Lohr, therefore, the lower courts should affirm preemption in cases involving PMA devices.

Medical Device Preemption After Medtronic, Inc. v. Lohr
Author: Mary Beth Neraas
Issue: 51 Food and Drug Law Journal 619-629 (1996)

This article explores what is now left of the medical device preemption defense after the United States Supreme Court’s June 26, 1996 decision in Medtronic, Inc. v. Lohr. The article concludes that the Supreme Court’s decision seems to largely eliminate the preemption defense in tort cases involving medical devices cleared by the Food and Drug Administration (FDA) under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA). The decision, however, should not impede substantially the availability of the preemption defense in personal injury cases involving investigational devices and devices approved by the FDA through the premarket approval process. Moreover, the article concludes that the preemption provision in the FDCA still should be deemed to preempt common law claims that conflict with FDA regulatory requirements that are device specific, e.g., the FDA’s labeling rules governing hearing aid devices, intrauterine contraceptive devices, and tampons.

The FDA Export Reform and Enhancement Act of 1996:
The FDA’s New Extraterritorial Authority Over Labeling and Promotional Practices
Author: Ansis M. Helmanis
Issue: 51 Food and Drug Law Journal 631-635 (1996)

The issue addressed in this article is a sweeping new extraterritorial regulatory authority granted the Food and Drug Administration (FDA) by the 1996 Export Act over labeling and promotional practices in foreign countries. It identifies potential concerns this provision poses for regulated industry as well as the public health and welfare of foreign countries. It draws on past experience with the 1986 Export Act to underscore the need for all interested parties to monitor FDA implementation of this new authority to ensure that congressional intent is not changed. Most important, it notes the need for the FDA to recognize the interest of local public health and welfare as expressed by sovereign foreign public health officials during consultations with the agency.

The New Drug Marketing: A Consumer Protection Perspective
Author: David Woodward
Issue: 51 Food and Drug Law Journal 637-650 (1996)

Recent acquisitions by pharmaceutical companies of prescription benefit management (PBM) businesses affect millions of American consumers and offer the Food and Drug Administration (FDA) a special opportunity to exercise its broad jurisdiction in a challenging new health-care environment. This article provides an overview of recent acquisitions and affiliations between drug manufacturers and PBM companies, highlighting the nationwide scope of these fundamental market transformations; discusses the FDA’s traditional jurisdiction over prescription drug labeling, advertising and promotional activity; and urges as initial steps applying the standards articulated in a recent multistate consumer law settlement between seventeen states and a large pharmaceutical company and its acquired PBM, improving and safeguarding the flow of information between PBM pharmacists and physicians, and furthering the public interest in the provision of truthful, nonmisleading information to consumers and the protection of consumers’ privacy interests in confidential health care data.

Teaching the Elephant to Dance: Privatizing the FDA Review Process
Author: Elizabeth C. Price
Issue: 51 Food and Drug law Journal 651-676 (1996)

The Food and Drug Administration (FDA) recently came under a criticism that it acts too slowly in reviewing new product applications, imposes needless and costly regulation, and engages in abusive practices against regulated entities that criticize or challenge its decisions. The resulting harm, according to the critics, is a loss of beneficial or even life-saving products for U.S. consumers and a loss of U.S. jobs to foreign shores. The critics have found a sympathetic ear in a Republican Congress that has launched a movement against the FDA, demanding comprehensive reform of the way the agency does business. Perhaps the most controversial aspect of the proposed reforms is whether (or to what extent) the FDA’s review function should be "privatized," i.e., whether the FDA’s current monopoly as the sole reviewer of the safety and efficacy of drugs, food additives, and medical devices should be broken. This article explores the privatization concept in-depth, discussing such topics as: what is the genesis of the privatization movement? What does the term "privatization" mean? What legislative and regulatory privatization proposals have been put forth thus far? What entities could compete with the FDA? How would consumers be affected? How could conflicts of interest be minimized? The article concludes that privatization of the FDA’s review function is normatively desirable. Specifically, because the current system of product review often results in excessive causation and regulation, breaking the FDA’s review monopoly could eliminate or change this situation, speeding review and enhancing regulatory efficiency. Providing statutory standards of safety and efficacy are unaltered and the FDA retains veto authority over any private reviewer’s decision, breaking the FDA monopoly holds the greatest long-term promise to "teach the elephant to dance" without compromising consumer safety.

FDA Rulemaking After the 104th Congress: Major Rules Enter the Twilight Zone of Review
Author: James T. O’Reilly
Issue: 51 Food and Drug law Journal 677-695 (1996)

Congress has adopted four pieces of rulemaking-related legislation during the 104th Congress that will impact on how the Food and Drug Administration (FDA) makes its rules and when those rules will become effective. The most significant of these allows Congress to delay a rule with a "joint resolution of disapproval" and to veto the rule by passing legislation that will invalidate the regulation. Congress also imposed new duties to conduct evaluations of impacts, to select the least costly alternative, and to provide small businesses the plain-language compliance explanations and the specific compliance advice that the FDA has not provided in the past. More costs of rulemaking may induce the FDA to avoid discretionary or optional rules, and concentrate its efforts on the rules made necessary by a statute or major health concern.

Legal Overview of Likely FDA Regulation of Internet Promotion
Author: Marc J. Scheineson
Issue: 51 Food and Drug Law Journal 697-716 (1996)

The traffic on the information superhighway is being directed increasingly to consumers and prescribers of pharmaceutical drugs, biologics, and medical devices. Dozens of new home pages and web sites are popping up on the Internet and World Wide Web (WWW) daily. Many of these promotional mediums are sponsored by drug and device manufacturers. This information has become so prolific that a separate Pharmaceutical Information Network (PharmInfoNet) now organizes and indexes private, government, and academic databases. These information sources span the spectrum from government disseminators (including the National Institutes of Health, the National Library of Medicine, the Agency for Health Care Policy and Research , the Food and Drug Administration (FDA), and many others) to medical schools, patient support groups, and pharmaceutical, biologic, and device manufacturers.Both the FDA and Federal Trade Commission (FTC) have noticed these developments. This article focuses on actions likely to be taken by the FDA. The FDA’s concerns have centered on the potential of drug and device manufacturers to promote products for uses not approved by it and contained within its approved labeling. An internal FDA Internet working group continues to meet to discuss regulation and surveillance. That group is composed primarily of officials from the FDA Center for Drug Evaluation and Research Division of Drug Marketing, Advertising, and Communications, the FDA Commissioner’s Office of Policy, and representatives of the promotions and advertising policy staff from each FDA center.This article examines the structures used currently by drug and device manufacturers to promote products on the Internet and WWW. Those structures are analyzed under the strictures of the Federal Food, Drug, and Cosmetic Act, its regulations, and FDA policy guidance documents. Specific recommendations are made and conclusions reached concerning the propriety of disseminating particular information using this new information superhighway.

The European Market for Food Products
Author: Guido Kayaert
Issue: 51 Food and Drug Law Journal 717-725 (1996)

The market situation in Europe to a large extent is influenced by the ongoing development of the European Union (EU), and by the changing political and economical systems in the central and east European countries. More than ten years after its conception, the Single Market in the EU is still considered to be the major tool to create business opportunities in Europe. Efforts remain focused on its further development and optimization. The basic principles of the Internal Market program are still valid today. Some key issues currently under debate are the simplification of the vertical directives. With the Internal Market legislation largely in place, attention also must be paid to the management of the system and to equivalent enforcement throughout the EU. The Internal Market, notwithstanding the remaining practical problems, is a success. The process, however, is not finished. Plans for simplification, improved coherence of legislation, and a reduction in administrative burden are being discussed. This is the ideal occasion to bring legislation in line with the international trade agreements.

Globalization of a Food Processor
Author: John Ruff
Issue: 51 Food and Drug Law Journal 727-000 (1996)

For a company to become international today, strategy decisions must be made in three areas: (1) organization; a company must find the proper balance between global and local decisionmaking; (2) geographical expansion; and (3) consistency/variation in product and marketing; a company must understand the product’s core elements (and not to tamper with them) as opposed to its peripheral elements (which can be modified), and the consumers’ level of familiarity with the product (since consumers may need to be shown new ways to use it). There are organizational impediments to globalization (i.e,. difficulty in working with matrix management), however, and the technology community can be the facilitator and champion of globalization.