Volume 53 Issue 2
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Table of Contents
> Off-Label Promotion: Is FDA’s Final
Guidance on Industry-Supported Scientific and
Educational
Programs Enforceable?
> Surfing the Net in Shallow Waters: Product
Liability Concerns and Advertising on the Internet
> The New Restatement (Third) of Torts—Shelter
From the Product Liability Storm for Pharmaceutical Companies
and Medical Device Manufacturers?
> About-Face: How FDA Changed Its Mind, Took
on the Tobacco Companies
in Their Own Back Yard, and Won
> Food and Drug Administration Modernization
Act of 1997: Medical Device Provisions
> Medtronic v. Lohr:
For Want of a Word, the Patient Was Almost Lost—Fixing
the Mischief Caused in Cipollone by Dividing the Preemption
Stream
> FDA’s Efforts to Improve Access to Agency
Records
> FDA’s Consideration of Codex Alimentarius
Standards in Light of International Trade Agreements
> Update on FSIS Initiatives
> Ethical Issues in the Patenting of Medical
Procedures
> Xenotransplantation: Ethics and Economics
Off-Label Promotion: Is FDA’s
Final Guidance on Industry-Supported Scientific
and Educational Programs
Enforceable?
Authors: I. Scott Bass, Paul E. Kalb & Bradford
A. Berenson
Issue: 53 Food and Drug Law Journal 193-212 (1998)
In December 1997, the Food and Drug Administration (FDA) issued its final guidance on industry-supported scientific and educational programs. This guidance establishes the rules under which drug and device manufacturers legally may support educational programs, including those relating to unapproved uses. The most notable aspect of this guidance is that the agency appears to rely on a legal theory different from the one on which it relied in support of its draft version of the guidance, which was published in 1992. The article first describes the new guidance and differentiates it from the draft version. It then reviews the legal problems with the old rationale. Finally, the article describes the agency’s new rationale and analyzes the statutory, regulatory, and First Amendment problems with that rationale. The article concludes that, while FDA has an interest in preventing the dissemination of fraudulent information, the guidance ultimately is beyond the agency’s statutory and constitutional authority because it seeks to regulate the exchange of truthful scientific information.
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Surfing the Net in Shallow Waters:
Product Liability Concerns and Advertising on the Internet
Authors: Marilyn A. Moberg, James W. Wood &
Howard L. Dorfman
Issue: 53 Food and Drug Law Journal 213-224 (1998)
The Internet provides unprecedented opportunities for manufacturers and researchers to disseminate information about the benefits and risks of medical devices and pharmaceuticals. Instant, worldwide communication means that health practitioners and patients can better educate themselves about available treatments. The Internet also provides a remarkable marketing opportunity.
With these opportunities, however, come both responsibility and concern about potential liability, which have caught the attention of the Food and Drug Administration and the courts. When patients educate themselves about medical products, for example, manufacturers must decide how to provide warnings against off-label uses, or uses approved in some countries but not others. This problem is compounded by hypertext links from sites over which manufacturers have no control. If manufacturers and their attorneys are aware of these issues, however, and review their Internet materials in light of the statutes and regulations governing advertising and labeling, they can face the challenges discussed in this article.
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The New Restatement (Third) of
Torts—Shelter From the Product Liability Storm for Pharmaceutical
Companies and Medical Device Manufacturers?
Authors: Michael J. Wagner & Laura L. Peterson
Issue: 53 Food and Drug Law Journal 225-242 (1998).
This article highlights the key provisions of the Restatement (Third) of Torts, Products Liability that address liability standards for drug and medical device manufacturers, and analyzes some of the more controversial standards set forth by the Restatement (Third)’s drafters. The article overviews the Restatement (Third)’s provisions relating to design defects and warning defects (including the duty to warn of product defects after sale or distribution), and provides guidance on how these provisions may be treated by courts and employed by practitioners in product liability litigation.
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About-Face: How FDA Changed Its
Mind, Took on the Tobacco Companies
in Their Own Back Yard, and Won
Author: David A. Rienzo
Issue: 53 Food and Drug Law Journal 243-266 (1998)
This article discusses the Food and Drug Administration’s (FDA’s) longstanding reluctance to exert jurisdiction over tobacco products, and the agency’s reversal of that position as discussed in the 1995 jurisdictional analysis and as evidenced by the 1996 final rule. The article then reviews Coyne Beahm, Inc. v. FDA, the court case in which the tobacco companies challenged FDA’s assertion of jurisdiction. The U.S. District Court for the Middle District of North Carolina upheld the majority of FDA’s claims. The article explains how FDA prevailed and why the court resolved the jurisdictional issues in FDA’s favor. The article also briefly analyzes the constitutional issues regarding FDA’s attempted regulation of tobacco advertisements, in light of the Supreme Court’s current commercial speech jurisprudence.
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Food and Drug Administration Modernization
Act of 1997: Medical Device Provisions
Author: Larry R. Pilot & Daniel R. Waldmann
Issue: 53 Food and Drug Law Journal 267-296 (1998)
The medical device provisions of the Federal Food, Drug, and Cosmetic Act continue their evolution with the enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Congress made clear in FDAMA that the Food and Drug Administration’s (FDA’s) mission is not limited to protection of public health by preventing distribution of unsafe products, but also requires timely review and approval of beneficial new products. This article seeks to summarize and explain changes made by FDAMA that are applicable to devices.
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Medtronic v. Lohr: For Want
of a Word, the Patient Was Almost Lost—
Fixing the Mischief Caused
in Cipollone by Dividing the Preemption Stream
Author: Suzanne Darrow Kleinhaus
Issue: 53 Food and Drug Law Journal 297-320 (1998)
This article provides an evaluation of the U.S. Supreme Court’s three separate opinions in Medtronic v. Lohr and offers a proposal for resolving the preemption issue left open by the case by providing a definition for the word "requirement" in the Medical Device Amendments (MDA). Because the real dilemma posed by the Medtronic decision was its failure to define criteria by which particular MDA "requirements" can be determined to be preemptive of common law claims, post-Medtronic lower courts have continued to face the question of what constitutes a preemptive MDA requirement. Consequently, some courts have focused erroneously on device classification as determinative of preemptive status. This article discusses the flaws in such reasoning. While the Medtronic Court may have neglected to hold that state common law tort actions do not impose "requirements" within the meaning of the MDA, it nevertheless provided the means to do so by affirming the role and authority of the Food and Drug Administration (FDA). Therefore, this article proposes that FDA define "requirement" as "requirement specification" in its regulations. This definition, based on the technological nature of the MDA and the circumstances surrounding the adoption of those amendments, would resolve the preemption issue left open by the Medtronic Court.
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FDA’s Efforts to Improve Access
to Agency Records
Author: Arvin P. Shroff & Sharon M. Sheehan
Issue: 53 Food and Drug Law Journal 321-326 (1998)
The Food and Drug Administration (FDA) is making a deliberate effort to ensure that more of its records are available to citizens, as well as to local, state, and foreign government requesters, in an expeditious and timely manner. FDA’s sharing of information is an integral part of its role as participant in policymaking and other collaborative regulatory efforts with other federal government agencies and with its counterpart agencies in the states and other countries. This article focuses on the availability of FDA records that are considered public because they are not specifically exempted from disclosure or excluded from the Freedom of Information Act’s coverage. The article also addresses the availability of records that contain confidential or nonpublic personal information that may be private, commercial, or governmental. Such sharing or nonpublic information will not be at the expense of maintaining the confidentiality of information that should be protected. FDA is achieving its goal in part through the use of newer technologies (including information technology), by increasing the number of records that are available through various channels (including the Internet), and by improving the efficiency of its information-sharing procedures.
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FDA’s Consideration of Codex
Alimentarius Standards in Light of International Trade Agreements
Author: Lucinda Sikes
Issue: 53 Food And Drug Law Journal 327-336 (1998)
This article addresses the impact recent international trade agreements have had on the status of standards set by the Codex Alimentarius Commission, an international food standard-setting organization. Although originally designed to facilitate smooth trading negotiations and to serve as a minimum floor of acceptable food quality for less developed countries, Codex standards became the presumptive international standards for food safety and labeling with adoption of the Uruguay Round of the General Agreement on Tariffs and Trade in 1994.
In response to these international changes, the Food and Drug Administration (FDA) is considering whether it should amend its regulations governing procedures for the review and evaluation of Codex standards. This article discusses significant problems in the Codex standard-setting process and offers specific suggestions to ensure that FDA’s consideration of Codex standards does not undermine the public health.
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Update on FSIS Initiatives
Author: Margaret Glavin
Issue: 53 Food and Drug Law Journal 337-340 (1998)
The Food and Safety Inspection Service (FSIS) actively has been implementing its final rule on Pathogen Reduction and Hazard Analysis Critical Control Points since January 1997. Implementation will be completed by January 2000. FSIS has held numerous public meetings to receive input and provide assistance to plants required to implement the provisions of the final rule.
While implementation is proceeding, FSIS has been working closely with federal and state government agencies to determine how to broaden FSIS’ connections with both levels of government to better meet consumer protection goals. Critical issues being examined include the appropriate roles for federal, state, and local governments, and how to engage stakeholders in establishing frameworks for partnerships. FSIS also is working closely with the Food and Drug Administration to develop a science-based, farm-to-table strategy for egg safety and is consolidating, streamlining, and clarifying many of its regulations for meat and poultry.
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Ethical Issues in the Patenting of Medical Procedures
Author: American Medical Association Council on
Ethical and Judicial Affairs
Issue: 53 Food and Drug Law Journal 341-352 (1998)
The patenting of medical procedures has been criticized on general grounds. Commentators have argued that it raises the cost of the patented procedure, thereby limiting patient access to the procedures. In addition, patenting restricts access in the research community, constraining opportunity for peer review and further research that would build on or use a patented technique. Physicians should strive to advance medical science and make their advances known to patients, colleagues, and the public. A physician has the ethical responsibility not only to learn from, but also to contribute to, the total store of scientific knowledge when possible. This obligation provides not merely an incentive but an imperative to innovate and share the ensuing advances. The patenting of medical procedures poses substantial risks to the progress of medicine by limiting the availability of new procedures to patients. Accordingly, the American Medical Association’s Council on Ethical and Judicial Affairs believes that it is unethical for physicians to seek, secure, or enforce patents on medical procedures.
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Xenotransplantation: Ethics and Economics
Author: Jack M. Kress
Issue: 53 Food and Drug Law Journal 353-384 (1998)
The ethical issues raised by xenotransplantation are broad. Discussions of ethical issues, however, often come from a single religious or ideological perspective without providing a full or fair hearing to alternative voices. The aim of this article is to offer the concerned reader a broadly based "think piece," viewing xenotransplantation from a different, unique, and, hopefully, more balanced perspective than usually has been the case. The goal of the article is to suggest topics ripe for reconsideration, and more to raise questions about them than to answer them.
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