Volume 54 Issue 4
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Table of Contents
> A
History and Perspective on Direct-to-Consumer Promotion
> Medical
Device Labeling and Advertising: An Overview
> Devaluing
Truth: Unverified Health Claims in the Aftermath of Pearson
v. Shalala
> FDA
Marketing v. First Amendment: Washington Legal Foundation Legal
Challenges
to Off-Label Policies May Force Unprecedented Changes
at FDA
> Guidelines
for the Promotion of Dietary Supplements: Examining Government
Regulation
Five Years After Enactment of the Dietary Supplement
Health and Education Act of 1994
> DSHEA's
Third-Party Literature Exemption: Mail Order Sales, Direct Marketing,
and Internet Use
> DSHEA
Provisions Confine FDA's Authority to Issue Regulations That
Concern
Allegedly Adulterated Dietary Supplements
> Regulating
Drug Promotion on the Internet
> Regulation
of Dietary Supplements: Five Years of DSHEA
> Is
It Worth the Trouble? The New Policy on Dissemination of Information
on Off-Label Drug Use
Under the Food and Drug Administration
Modernization Act of 1997
> Special
Labeling Requirements for Genetically Engineered Food:
How Sound
Are the Analytical Frameworks Used by FDA and Food Producers?
A History and Perspective on Direct-to-Consumer Promotion
Issue: 54 Food and Drug Law Journal 489-518 (1999).
Author: Wayne L. Pines
Direct-to-consumer (DTC) advertising has been a way in which consumers could receive medical information about health conditions and possible treatments. This article looks at the history of DTC advertising, including enforcement and regulation by the Food and Drug Administration. The author also discusses various studies conducted on the effectiveness of DTC advertising, and the amount of money spent on marketing. The author identifies viewpoints taken by opponents and supporters of DTC advertising, and concludes with observations on elements that need to be considered to improve DTC advertising in the years to come.
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Medical
Device Labeling and Advertising: An Overview
Author:
Edward M. Basile, Ellen Armentrout & Kelly N. Reeves
Issue: 54 Food and Drug Law Journal 519-534 (1999).
The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act to regulate the labeling and promotion of all medical devices. The regulation of medical device labeling and promotion, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily. Particular areas of current concern are: the promotion of uncleared or unapproved devices and uses; Internet promotion; press releases; and comparative claims. This article summarizes current law and FDA's regulation of medical devices, and discusses the ways that FDA has chosen to address the new issues and how medical device manufacturers are affected.
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Devaluing
Truth: Unverified Health Claims in the Aftermath of Pearson v. Shalala
Author:
David C. Vladeck
Issue: 54 Food and Drug Law Journal 535-554 (1999).
This article examines the recent decision of the U.S. Court of Appeals in Pearson v. Shalala, which struck down the Food and Drug Administration's (FDA's) regulatory scheme for approving health claims for dietary supplements. Implementing Congress' mandate in the Nutritional Labeling and Education Act of 1990 (NLEA), FDA determined that health claims lacking significant scientific agreement are inherently misleading and may be forbidden categorically under the First Amendment. Dietary supplement manufacturers disagreed and sued.
In its ruling, the Pearson court rejected FDA's view that health claims that cannot be proven to be either true or false pose a serious risk to consumers. Although the court recognized that some health claims will mislead consumers, it reasoned that FDA's regulations are nonetheless impermissibly restrictive because they do not allow manufacturers to make health claims accompanied by clarifying disclosures where significant scientific agreement is lacking. The court suggested that disclaimers referring to the absence of FDA approval, or the "inconclusive" nature of the scientific evidence, might be sufficient to guard against consumer deception.
This article explains why the reasoning of Pearson misconceives basic First Amendment commercial speech principles and places the public at risk. Although the Supreme Court has, on occasion, approved the use of government-required disclaimers to guard against potentially deceptive speech, the Court has never directed a government agency to permit potentially misleading speech so long as it is accompanied by a disclaimer. The Pearson court's decision to do so in this case is at odds with substantial precedent.
Nor do the disclaimers envisioned by the court solve the consumers' dilemma. Congress enacted the NLEA to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements. Pearson thwarts that purpose. Nothing in the disclaimers recommended by the court will help consumers appraise the safety, efficacy, or reliability of dietary supplements. To the contrary, the disclaimers envisioned by the court will simply underscore the uncertainty about the product's utility. Accordingly, Pearson relegates consumers to a marketplace that will be rife with unproven and unreliable health claims, and thus poses a real threat to the health of consumers.
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FDA
Marketing v. First Amendment: Washington Legal Foundation Legal Challenges
to Off-Label Policies May Force Unprecedented Changes at FDA
Author:
John Kamp, Daniel E. Troy & Elizabeth Alexander
Issue: 54 Food and Drug Law Journal 556-566 (1999).
The U.S. District Court for the District of Columbia recently altered the way the Food and Drug Administration (FDA) may regulate marketing of off-label uses for prescription drugs. The Washington Legal Foundation (WLF) challenged FDA policy on First Amendment grounds. Judge Lamberth of the district court determined that an industry "pervasively regulated" by the federal government is entitled to First Amendment protection. He also determined that the "commercial speech" test, as set forth by the Supreme Court in Central Hudson Gas & Electric Co. v. Public Service Comm'n of New York, was applicable to FDA's marketing policy. This paper examines the history behind Judge Lamberth's decisions in the WLF cases and what impact those decisions may have.
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Guidelines
for the Promotion of Dietary Supplements: Examining Government Regulation
Five Years After Enactment of the Dietary Supplement Health and Education
Act of 1994
Author:
Robert G. Pinco & Todd H. Halpern
Issue: 54 Food and Drug Law Journal 567-586 (1999).
This article examines the recent legal and regulatory issues that have arisen since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Topics include the decision of the District Court of Utah in Pharmanex v. Shalala, the regulatory framework governing the use of "health claims" (including the potential impact of the D.C. Circuit Court's opinion in Pearson v. Shalala on those regulations), the FDA-proposed rule regarding the use of structure/function claims, and a discussion of regulation by other governmental and nongovernmental entities, including the Federal Trade Commission and the National Advertising Division of the Better Business Bureau. The authors explain how flawed agency policies have undermined the goal of DSHEA to remove "unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers," as well as the reason that some of those policies have been found to be unconstitutional. In addition, the authors demonstrate how the absence of FDA enforcement activity has made it difficult for manufacturers of quality, standardized dietary supplements to compete in a market deluged with inexpensive, substandard products.
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DSHEA's
Third-Party Literature Exemption: Mail Order Sales, Direct Marketing,
and Internet Use
Author:
Charles J. Raubicheck
Issue: 54 Food and Drug Law Journal 587-594 (1999).
The Dietary Supplement Health and Education Act of 1994 (DSHEA) permits persons or entities, other than manufacturers or distributors, to distribute to consumers certain publications in connection with the sale of particular supplements. These publications may include statements about the therapeutic benefits of such products without subjecting the products to regulation by the Food and Drug Administration (FDA) as unapproved new drugs. Under DSHEA, third parties disseminate information about supplements in a variety of ways. Third parties may distribute literature in connection with the sale of dietary supplements in retail stores. Also, third parties may send publications along with multiple supplements as long as the publications describe at least one of the supplements. Additionally, publications can be mailed along with catalogs to consumers. Finally, third parties may use the Internet as long as they use a company website where supplements can be purchased. Thus, third parties have a variety a ways to provide the public with information on supplements without having to go through FDA approval.
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DSHEA
Provisions Confine FDA's Authority to Issue Regulations That Concern
Allegedly Adulterated Dietary Supplements
Author:
Stephen H. McNamara, A. Wes Siegner, Jr. & Evan P. Phelps
Issue: 54 Food and Drug Law Journal 595-598 (1999).
Section 701(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes the issuance of regulations "for the efficient enforcement of this Act." Generally, it has been accepted that this section provides the Food and Drug Administration (FDA) considerable authority to issue, by means of notice-and-comment rulemaking procedures, regulations that interpret or enforce the requirements of the FDCA and that have the force and effect of law. FDA has relied on this rulemaking authority to ban or restrict the potency of various ingredients in products it regulates. Recently, relying on this assumed authority, the agency has proposed regulations that would severely restrict the use of the dietary ingredient ephedra in dietary supplement products. The authors of this article maintain that pursuant to new, explicit, and unique provisions in the Dietary Supplement Health and Education Act (DSHEA), which amends the FDCA with respect to dietary supplement products, FDA now lacks authority to issue regulations that have the force and effect of law based on section 701(a) and the adulteration provisions of sections 402(a)(1) and (f)(1) of the FDCA. Instead, pursuant to DSHEA, in any judicial enforcement action brought by the United States against a dietary supplement product based on an allegation that the product is adulterated because of the presence or potency of a dietary ingredient, the government bears the "burden of proof on each element" on a "de novo basis" to establish that the dietary supplement is adulterated under the statute, and that the government cannot rely on an asserted violation of the terms of a regulation as proof of violation of the FDCA. Accordingly, the authors maintain that, instead of issuing regulations to interpret the FDCA's adulteration provisions with respect to particular dietary ingredients in dietary supplement products, FDA should issue nonbinding guidelines. Guidelines can be issued more efficiently than regulations, and a regulation in these circumstances would not have any greater legal status than a guideline.
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Regulating
Drug Promotion on the Internet
Author: Leah Brannon
Issue: 54 Food and Drug Law Journal 599-622 (1999).
When the ban on commercial traffic on the Internet was lifted in 1991, drug manufacturers joined other commercial enterprises in promoting their products on-line. As the popularity of the new medium grew, so too did the number of drug manufacturers with a presence on the Internet. But regulation designed for traditional media did not translate easily to the Internet, and wild drug claims began to proliferate unchecked. At a 1996 Food and Drug Administration (FDA) conference regarding drug promotion on the Internet, FDA officials stated their intent to develop comprehensive guidance for on-line drug promotion. This article addresses FDA's efforts, examines the obstacles that have prevented the agency from issuing comprehensive guidance to date, and sketches an outline for proposed FDA regulation of drug promotion on the Internet.
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Regulation
of Dietary Supplements: Five Years of DSHEA
Author: Laura A.W. Khatcheressian
Issue: 54 Food and Drug Law Journal 623-644 (1999).
The Dietary Supplement Health and Education Act of 1994 (DSHEA) was a radical change in the regulatory landscape for the marketing and labeling of dietary supplements. DSHEA restricts the Food and Drug Administration's (FDA's) authority to regulate this area of products and encourages the sale of certain vitamins, minerals, herbs, botanical products, and amino acids, which are advertised often as alternatives to more traditional medical care. While many of these products can be helpful if used properly, the current legislation does not protect consumers from dangerous, ineffective, and impure products. This article examines DSHEA and the regulatory efforts of FDA, discusses the recent growth of the dietary supplement industry and some concerns arising from that growth, and offers a proposal for congressional change to the regulatory framework that would increase consumer knowledge of the safety and efficacy of dietary supplements.
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Is
It Worth the Trouble? The New Policy on Dissemination of Information
on Off-Label Drug Use Under the Food and Drug Administration Modernization
Act of 1997
Author: Elizabeth A. Weeks
Issue: 54 Food and Drug Law Journal 645-666 (1999).
In 1997, Congress passed the Food and Drug Administration Modernization Act, which included a provision relaxing the Food and Drug Administration's long-standing prohibition on promotion of off-label use of previously approved products. Although the provision on dissemination of information on unapproved uses had been anticipated eagerly by many commentators, physicians, and patients, this paper concludes that the hope for real reform has been sorely disappointed by the intricate statutory and regulatory scheme. As enacted, the dissemination provision provides inadequate incentives for drug manufacturers to seek agency approval before distributing information regarding off-label uses of their products. This paper advocates a system of priority review for supplemental new drug applications submitted with requests to disseminate information on off-label uses. This system would create adequate incentives for manufacturers to comply with the new policy.
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Special
Labeling Requirements for Genetically Engineered Food:
How Sound Are
the Analytical Frameworks Used by FDA and Food Producers?
Author: Lara Beth Winn
Issue: 54 Food and Drug Law Journal 667-688 (1999).
Despite the benefits genetically engineered food may offer, many consumers would rather leave it off their tables. This, however, is nearly impossible to do in the United States, because the Food and Drug Administration (FDA) generally does not require biotechnology food producers to place special labels on their products, and producers do not do so voluntarily. Both FDA and producers base their positions on analyses that contain weaknesses. FDA's evaluation of the labeling issue is deficient in three ways. First, the agency arguably erred in interpreting the misbranding provision of the Federal Food, Drug, and Cosmetic Act. Second, FDA's analysis is inconsistent with its analyses of similar issues that involve disclosing information to consumers. Third, FDA failed to consider international issues, even though other countries are affected by the U.S. labeling policy. Although biotechnology food producers approach the labeling issue differently, their analysis is deficient in three ways as well. First, producers argue that special labels will scare consumers away from their products, but producers overestimate the difficulties of combating consumer backlash. Second, producers claim that labeling should not be required because it will result in special labels on all food, when in fact, a reasonable line can be drawn to determine which food should bear a special label. Third, producers fear that labeling will introduce burdensome costs, but in reality, a large portion of these costs would be incurred even in the absence of labeling. In short, although both FDA and biotechnology food producers raise important and insightful issues in their evaluations of the food labeling debate, their analyses are not as sound as they first
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