Volume 58 Issue 3
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Table of Contents
>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.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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