FDLI Publications: Food and Drug Law Journal 58-3

Volume 58 Issue 3

FDLI's policy regarding the Food and Drug Law Journal online is: Only the Table of Contents and article abstracts for each issue will be posted to our website. Those visitors wishing to obtain a full text version of a particular article, or a copy of an entire issue, may contact FDLI’s Customer Service Department by e-mail at service@fdli.org. Your purchase will be processed quickly, and at reasonable rates.

Any questions or concerns regarding this policy should be directed to
Michael Levin-Epstein, FDLI's Editor-in-Chief.

>A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions on the Promotion of Prescription Drugs
by Henry A. Waxman (D-CA), ranking member of the House Committee on Government Reform and a senior member of the House Committee on Energy and Commerce, both of which have jurisdiction over the Food and Drug Administration.

> Courts Are Arriving at a Consensus on Food and Drug Administration Speech Regulation
by Richard A. Samp, Chief Counsel of the Washington Legal Foundation, Washington, D.C. He represented the plaintiff in one of the cases discussed in this article: Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), appeal dismissed, 202 F.3d 331 (D.C. Cir. 2000).

> Ripe for Revision: Reassessing the Constitutionality of Food and Drug Administration
Restrictions on Protected Speech
by Jeffrey N. Gibbs, Member in the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.

Paul L. Ferrari, Associate in the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.

Anne Marie Murphy, Associate in the law firm of Hyman, Phelps & McNamara, P.C., Washington, D.C.

> The Supreme Court Checks Out Drug Promotion Restrictions
by Margaret Gilhooley, Professor of Law, Seton Hall University, Newark, NJ.

> The First Amendment and the Food and Drug Administration's Regulation of Labeling and Advertising: Three Proposed Reforms
by Jonathan S. Kahan, Partner in the law firm of Hogan & Hartson L.L.P., Washington, D.C. and co-director of the firm's Food, Drug, Medical Device, and Agriculture Group.

Jeffrey K. Shapiro, Partner in the law firm of Hogan & Hartson L.L.P., Washington, D.C. and a member of the firm's Food, Drug, Medical Device, and Agriculture Group.

> FDA Regulation of Prescription Drug Manufacturer Speech: A First Amendment Analysis
by George W. Evans, Associate General Counsel of Pfizer Inc, New York, NY.
Arnold I. Friede, Senior Corporate Counsel, Pfizer Inc, New York, NY.

> Drug Manufacturers' First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory
by A. Elizabeth Blackwell, Associate in the Philadelphia office of Dechert, L.L.P.
James M. Beck, Of Counsel in the Philadelphia office of Dechert, L.L.P.

> Protecting Protected Speech: First Amendment Taxonomy and the Food and Drug Administration's Regulation of "Enduring Materials
by Daniel J. Gilman, Associate in the FDA practice group at the law firm of Hogan & Hartson L.L.P., Washington, D.C., and Adjunct Professor of Law, Georgetown University Law Center.

> Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate
by Peggy Chen, Associate at the law firm of Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY.

> The Power of Positive Drinking: Are Alcoholic Beverage Health Claims Constitutionally Protected?
by Ben Lieberman, Senior Policy Analyst, Competitive Enterprise Institute, Washington, D.C.

> The Canadian Approach to Freedom of Expression and the Regulation of Food and Drug Advertising
by Elizabeth L. McNaughton, Partner with the law firm of Blake, Cassels & Graydon LLP, Toronto, Ontario, Canada.

Christopher M. Goodridge, Associate with the law firm of Blake, Cassels & Graydon LLP, Toronto, Ontario, Canada.

A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions
on the Promotion of Prescription Drugs
Author: Henry A. Waxman
Issue: 58 FOOD AND DRUG LAW JOURNAL 299-312 (2003).

In 2002, the Food and Drug Administration (FDA) issued a notice stating its belief that recent court decisions giving protections to commercial speech under the First Amendment may be in conflict with many of FDA's restrictions on promotion. The notice challenges the constitutionality of one of the cornerstones of the Federal Food, Drug, and Cosmetic Act: the requirement that new uses of drugs be shown to be effective before they are promoted. A restriction on commercial speech satisfies the First Amendment if it directly advances a substantial government interest, is based on evidence of real harm and alleviates the harm to a material degree, and is narrowly tailored to meet the desired ends. As described in detail in this article, the effectiveness requirement for drugs is based on evidence from a decade of congressional hearings about the harm that flows from a system that permits promotion of unapproved uses and relies on postmarket enforcement against misleading promotion. This evidence more than satisfies the requirements of the Constitution.

Courts Are Arriving at a Consensus on Food and Drug Administration Speech Regulation
Author: Richard A. Samp
Issue: 58 FOOD AND DRUG LAW JOURNAL 313-330 (2003).

Public policy advocates have widely disparate views on the extent to which the First Amendment imposes restraints on the Food and Drug Administration's (FDA's) regulation of manufacturers' speech. Courts quietly have begun to arrive at a consensus on this issue—a consensus that gives a little to both sides of the debate. Courts have shown a willingness to uphold FDA regulation of even wholly truthful speech, if the regulation serves some legitimate government interest and is not overly broad. At the same time, courts appear unwilling to accept as legitimate some of the interests upon which the government has relied in the past—particularly any interest based on a belief that the public is better off being kept in ignorance on certain topics. The Supreme Court's recent Western States decision typifies this middle-of-the-road approach. On one hand, the Court made clear that it was willing to tolerate significant FDA speech suppression, provided that FDA explains why such action is necessary to achieve its regulatory objectives. On the other hand, it rejected FDA's effort to justify a ban on advertisements for compounded drugs because the ban was based on nothing more than FDA's fears that obtaining this information might cause consumers to make foolish choices.

Ripe for Revision: Reassessing the Constitutionality of Food and Drug Administration
Restrictions on Protected Speech
Authors: Jeffrey N. Gibbs, Paul L. Ferrari & Anne Marie Murphy
Issue: 58 FOOD AND DRUG LAW JOURNAL 331-346 (2003).

A series of recent defeats in the courts—culminating with the U.S. Supreme Court's decision striking down a provision of the Federal Food, Drug, and Cosmetic Act that prohibited pharmacists from advertising their ability to compound specific drugs or categories of drugs—has led the Food and Drug Administration (FDA) to reexamine and seek public comment on its regulations, policies, and practices that may infringe the First Amendment rights of the regulated industry. This article focuses on two such provisions: the requirement that the sponsor of a new drug approved under FDA's accelerated approval regulations must submit all promotional materials for review by the agency prior to dissemination, and FDA's policies that restrict the dissemination of truthful information (e.g., abstracts and scientific posters) on "off-label" uses of approved products. This article takes the position that these provisions would fail to pass constitutional muster if challenged in court because they impermissibly restrict protected commercial speech. As such, these provisions are ripe for review and revision by the agency.

The Supreme Court Checks Out Drug Promotion Restrictions
Author: Margaret Gilhooley
Issue: 58 FOOD AND DRUG LAW JOURNAL 347-352 (2003).

This paper examines whether the Western States case supports the constitutional protection of manufacturers' distribution to physicians of medical journal article reprints about new uses of approved drugs, provided there is disclosure about the lack of Food and Drug Administration (FDA) approval. The analysis suggests that additional protections are needed, including prior notice to FDA before manufacturers distribute reprints and undertake further testing that might be necessary. An analysis also is made of the means that could be initiated to reduce the pressures on physicians that arise from the product-specific nature of direct-to-consumer advertising.

The First Amendment and the Food and Drug Administration's Regulation of Labeling and Advertising: Three Proposed Reforms
Authors: Jonathan S. Kahan & Jeffrey K. Shapiro
Issue: 58 FOOD AND DRUG LAW JOURNAL 353-364 (2003).

This article discusses the Supreme Court's decision in Thompson v. Western States Medical, which held that the Food and Drug Administration (FDA) must comply with the First Amendment. The authors urge FDA to revise current speech restrictions to comply with Western States. First, FDA should permit manufacturers to disseminate peer-reviewed journal articles and textbooks discussing off-label uses of their devices. Second, FDA should liberalize current restrictions on the dissemination of scientific findings about investigational devices. Finally, the article suggests that FDA allow manufacturers to disseminate truthful and nonmisleading post-approval clinical data about premarket application (PMA)-approved devices, without approval of a PMA supplement.

The Food and Drug Administration's Regulation of Prescription Drug Manufacturer Speech:
A First Amendment Analysis
Authors: George W. Evans & Arnold I. Friede
Issue: 58 FOOD AND DRUG LAW JOURNAL 365-438 (2003).

The Supreme Court's decision in Thompson v. Western States Medical Center has laid to rest any doubts about the First Amendment's general applicability to the Food and Drug Administration's (FDA's) regulatory scheme. This article addresses one subset of questions that arises in the wake of that case: the implications of free speech jurisprudence for the agency's regulation of prescription drugs. Respect for First Amendment values does not require adoption of an extremist position that no FDA speech restraint is viable; regulatory review of certain "information flows" is essential to protect public health and is acceptable under First Amendment jurisprudence. It is appropriate for the agency to have jurisdiction over products on the basis of manufacturers' claims, and to scrutinize the dosage, safety, and other usage information upon which prescribing decisions should be made. The agency's power to regulate truthful commercial speech is considerably more constrained, however, and its authority to check noncommercial communications by manufacturers is even more circumscribed. This article analyzes each step in the regulatory process to assess the constitutional limits of the agency's power to evaluate, ban, preclear, restrict, or mandate speech at every significant stage.

Drug Manufacturers' First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory
Authors: A. Elizabeth Blackwell & James M. Beck
58 FOOD AND DRUG LAW JOURNAL 439-462 (2003).

This article considers the constitutionality of the Food and Drug Administration's (FDA's) policies restricting drug manufacturers' speech promoting off-label uses of their products. The authors predict that FDA's current policies are unlikely to survive First Amendment scrutiny, particularly following the Supreme Court's decision in Thompson v. Western States Medical Center. The article considers how FDA might be expected to respond to any future invalidation of its current speech-restrictive policies, and concludes that simply relaxing existing speech restrictions to permit more speech regarding off-label uses is not a viable response for FDA. It predicts that future invalidation of FDA's current policies regarding off-label use may lead to the adoption of alternative nonspeech-restrictive policies designed to further the agency's regulatory interests. The article questions whether drug manufacturers might consider such alternatives even less desirable than existing policy.

Protecting Protected Speech: First Amendment Taxonomy and the Food and Drug Administration's Regulation of "Enduring Materials"
Author: Daniel J. Gilman
Issue: 58 FOOD AND DRUG LAW JOURNAL 463-472 (2003).

Numerous comments have called on the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of "enduring materials" (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think that such materials deserve a very high level of protection; 3) FDA restrictions on enduring materials are liable to be both constitutionally suspect and futile; and 4) FDA ought, therefore, to repudiate its prior restrictions on the dissemination of enduring materials.

Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate
Author: Peggy Chen
Issue: 58 FOOD AND DRUG LAW JOURNAL 473-510 (2003).

This article focuses on one of the recurring battlegrounds of the speech issue—industry sponsorship of continuing medical education (CME). The Food and Drug Administration's (FDA's) guidance on industry-sponsored CME bans speech about off-label uses, and requires that other speech presented at CME settings be truthful, nonmisleading, and fairly balanced. This article provides background on the FDA's regulatory authority over drug promotional activities, including drug approval, misbranding due to lack of adequate directions for use, and labeling and advertising. It also discusses the Washington Legal Foundation cases, which were brought to challenge the CME guidance as an unconstitutional restriction because it bans speech about off-label uses. The article examines the district court's holdings that industry-sponsored CME speech is commercial speech, and that FDA's regulation is unconstitutional because it is considerably more extensive than necessary to further the government's interest in getting new uses on-label. Lastly, the article examines the problem of representational speech, which arises when speech is tied to financial sponsorship. It finds that the guidance factors fail to establish a representative connection between the CME speaker and the pharmaceutical manufacturer such that the pharmaceutical manufacturer may be held responsible for the speaker's speech. Therefore, the CME guidance sweeps into its regulatory scheme not only commercial speech, but also core scientific speech that deserves the highest First Amendment protection.

The Power of Positive Drinking: Are Alcoholic Beverage Health Claims Constitutionally Protected?
Author: Ben Lieberman
Issue: 58 FOOD AND DRUG LAW JOURNAL 511-520(2003).

Published studies have shown it to be an accurate statement that moderate consumption of alcoholic beverages substantially reduces one's risk of contracting heart disease. Predictably, many alcoholic beverages industry members would like to put "heart healthy" messages on product labels and advertisements. The Department of the Treasury's Alcohol and Tobacco Tax and Trade Bureau, which has authority over alcoholic beverage labels and advertisements, asserts that any health-related claim would be misleading unless it detailed the risks of heavier drinking and explained every category of individual unlikely to benefit. The agency insists its policy is not a ban and does not violate the First Amendment. Recent commercial speech case law casts doubt, however, on the constitutionality of so broad a restriction. Legal precedent strongly suggests that there is a First Amendment right for producers to use, and consumers to read, accurate summary statements about moderate drinking and health on alcoholic beverage labels and advertisements.

The Canadian Approach to Freedom of Expression and the Regulation of Food and Drug Advertisin
Authors: Elizabeth L. McNaughton & Christopher M. Goodridge
Issue: 58 FOOD AND DRUG LAW JOURNAL 521-536 (2003).

Much like the situation in the United States, the Canadian legislature and judiciary have wrestled with the inherent conflict between constitutional guarantees of free speech and legislation designed to protect consumers and promote public health. This article provides an overview of the approach taken by Canadian courts to issues of free speech as it relates to commercial expression and legislative restrictions placed on food and drug advertising. The article discusses the general restrictions placed on food and drug advertising in the Canadian Food and Drugs Act and also addresses the new regulations under that Act that place restrictions on nutrition labeling, nutrient content claims, and diet-related health claims. The article then provides a synopsis of the case law under the Canadian Charter of Rights and Freedoms that has addressed the protection of commercial expression. Finally, the article analyzes the new Canadian regulations with respect to diet-related claims in light of the Charter's constitutional guarantee of freedom of expression.