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Volume 13, No. 9
© 2005 The Metropolitan Corporate Counsel, Inc.
September 2005
New Guidelines On Direct-to-Consumer Ads
For Prescription Drugs: Too Little Too Late?
Michael D. Ricciuti
and John A. Wortmann, Jr.
KIRKPATRICK & LOCKHART
NICHOLSON GRAHAM LLP
On August 2, 2005, the Pharmaceutical
Research and Manufacturers of America
(PhRMA) announced its adoption of “PhRMA
Guiding Principles – Direct to Consumer
Advertisements About Prescription Medicines”
(hereinafter “the Principles”). The Principles
are a set of voluntary restrictions on direct-toconsumer (“DTC”) prescription drug advertising that could substantially change how
prescription drugs are marketed. Although the
Principles do not have the force and effect of
law, several major pharmaceutical manufacturers have voiced support and have already stated
that they intend to follow (or in some instances
exceed) them.
In announcing the Principles on July 21,
PhRMA referenced the growing concerns of
consumers, doctors, and other health care professionals about prescription drug advertising.
Indeed, the Principles come amidst an explosion of drug-related personal injury litigation,
Congressional calls for more stringent controls
over DTC advertising, and increasing evidence
that the pharmaceutical industry is suffering
from a public relations crisis. For instance, on
August 19, 2005, a jury in Angleton, Texas
awarded the widow of a Vioxx user $253 mil-
Michael D. Ricciuti and John A. Wortmann, Jr. are former federal prosecutors
who are Partners in the Boston office of
Kirkpatrick & Lockhart Nicholson Graham (“K&LNG”). Both are also members
of K&LNG’s Bio Pharma Task Force, a
group of corporate, regulatory, and white
collar defense and trial lawyers formed to
address regulatory and litigation issues in
the Pharmaceutical Industry.
lion in the first wrongful death case based on
alleged Vioxx use. During the trial, plaintiff’s
counsel highlighted what he described as
“glitzy television ads” and other marketing
practices used to stimulate sales. The verdict
thus may be seen by many as confirmation of
issues surrounding the marketing of prescription drugs, and is likely to add to sentiment for
increased regulation over DTC advertising.
Thus, whether the Principles are too little, or
too late in the pharmaceutical industry’s efforts
to avoid further restrictions on drug advertising
remains to be seen.
A. Prescription Drug Advertising: An
Overview Of DTC Rules And Guidance
The Food and Drug Administration’s (“the
FDA”) promulgation of definitive regulations
for DTC advertising reflected the complexity of
the issues. Historically, prescription marketing
focused on promotions to physicians, hospitals
and other health care organizations. The historical market target group drove the FDA’s regulatory approach, since doctors were viewed as
the principal decision maker regarding the risks
and benefits of using a particular prescription
drug.
In 1981, however, the first print ad directed
at consumers ran in the United States. Even
though doctors still acted as gatekeepers – in
that they would ultimately decide whether to
prescribe an advertised drug for a particular
patient – DTC advertising raised concerns
about existing regulation. In 1982, the FDA
formally requested that the pharmaceutical
industry hold off on DTC ads while it reviewed
the issue. It did so, and in 1985, the FDA determined that the existing regulatory framework
was appropriate for DTC ads, which had to
meet the same legal requirements as ads
directed at doctors. Thereafter, the FDA issued
further direction, most significantly its “Guidance for Industry – Consumer-Directed Broadcast Advertisements,” issued in draft in 1997
and finalized in 1999 (hereinafter called the
“Guidance.”)
The law governing DTC ads is complex; a
full analysis here is not practicable. Generally,
current FDA regulations are aimed at product-
claim or indication advertisements, which promote a specific brand of drug for a particular
indication. Under the Federal Food, Drug and
Cosmetic Act (21 U.S.C. §352(n)), advertisements must include a “true statement” of,
among other things, “information in brief summary relating to side effects, contraindications,
and effectiveness.” This statement, often called
the “brief summary,” is more fully described in
FDA’s regulations which provide detailed guidance on what disclosures are required. Further,
the regulations also require that ads present a
“fair balance” between risks and benefits, and
go on to describe factors which may make
advertisements false, misleading or lacking in
fair balance.
Although the regulations govern both print
ads and broadcast ads, they make special provision for broadcast ads with respect to the “brief
summary” requirement. In print ads, it is practical for pharmaceutical companies to include
information necessary to satisfy the “brief summary” requirement in the text of the advertisement. This is far more difficult in radio or
television spots. Recognizing this, the FDA
regulations require that broadcast ads “include
information relating to the major side effects
and contraindications of the advertised drugs,”
which is sometimes called the major statement,
as well as the brief summary, “unless adequate
provision is made for dissemination of the
approved or permitted package labeling in connection with the broadcast presentation.” In
other words, the FDA regulations allow for
broadcast ads to provide less detailed information than print ads, so long as they adequately
provide that the information gets to recipients of
the ads in other ways.
The FDA fleshed out the adequate provision
requirement in the Guidance. To ensure that
“most of a potentially diverse audience …
[receives] reasonably convenient access to the
advertised product’s approved labeling,” companies can satisfy the adequate provision
requirement by providing full package labeling
through four mechanisms, all of which the
Guidance indicated ordinarily should be used:
• providing a toll-free number;
• referencing a dissemination mechanism,
Please email the authors at mricciuti@klng.com or jwortmann@klng.com
with questions about this article.
Volume 13, No. 9
© 2005 The Metropolitan Corporate Counsel, Inc.
such as concurrent print advertisements which
reach the exposed audience with the toll-free
number and an address or, in less frequent
cases, ensuring concurrent, wide public availability of brochures containing product
labeling;
• providing an internet web page;
• disclosing that pharmacists, physicians or
other health care providers may provide additional information to consumers.
More recently, the FDA has issued another
draft guidance, this one entitled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.” The
draft seeks to increase industry options in fulfilling the brief summary requirement other
than reprinting the entire section of approved
labeling on side effects and warnings because
consumers may be discouraged from using that
information. This guidance has not yet been
finalized.
B. DTC Advertising And Concerns
It Fostered
DTC advertising has exploded in recent
years. In 1991, the pharmaceutical industry
spent approximately $50 million on DTC ads.
Ten years later, advertising expenditures were
approaching $2.5 billion – a fifty-fold increase.
Moreover, approximately 70% of the industry’s
2001 advertising dollars were spent for television ads touting a small number of now well
known drugs.
As the industry’s DTC spending rose, so has
the debate over its effects and social utility. The
pharmaceutical industry has consistently maintained that DTC ads educate consumers about
new treatments and prompt them to seek appropriate medical advice earlier and more often.
Critics on the other hand, argue that many ads
are misleading, increase the overall cost of prescription drugs, and often pressure doctors into
prescribing advertised drugs even when there are
less expensive alternatives.
A 2002 survey conducted by the FDA found
doctors split on the overall effects of prescription drug advertising. Many doctors participating in the survey believed that ads prompted
their patients to ask appropriate questions about
available treatments and helped promote early
recognition of potentially adverse conditions.
At the same time, comparable numbers of doctors believed that the ads led many patients to
overestimate the efficacy of individual drugs
and created confusion about their effectiveness.
Controversy began to build in 2004 about
Vioxx and Celebrex, two well-known and heavily advertised prescription pain medications.
In 2000, Vioxx was the most-heavily advertised
prescription drug in the United States. Celebrex
was seventh. By 2003, the two drugs accounted
for more than $4 billion in sales in the United
States alone.
In 2004, reports linked the use of both Vioxx
and (to a lesser extent) Celebrex to increases in
the risk of certain cardiovascular problems.
Vioxx was withdrawn from the market, and
more than 4,000 lawsuits were brought against
its manufacturer. Although Celebrex has not
been withdrawn, it and other drugs in its class
are now required to include in all labeling
boxed warnings (the highest FDA warning level
provided under current regulations) highlighting this risk as well as “potentially life-threatening, gastrointestinal bleeding.” Celebrex has
reportedly been targeted in at least some personal injury suits, as well.
Perhaps not surprisingly, in April, Senators
Grassley and Dodd introduced the Food and
Drug Administration Safety Act of 2005, which
would establish the Center for Post-Market
Drug Evaluation and Research within the FDA.
This new office would conduct post-market risk
assessments on approved drugs and disseminate
information about the risks and benefits of such
drugs. The bill would also require the submission of DTC and other ads to the FDA prior to
dissemination and require further disclosures in
ads under certain conditions. In July, Senate
Majority Leader Bill Frist suggested a voluntary two-year moratorium on new drug advertising as part of a broad-based attack on the
pharmaceutical industry delivered on the Senate
Floor. Frist also called on the Government
Accountability Office to study the FDA’s oversight of DTC advertising, industry expenditures, and the impact of DTC advertising on
drug use, costs and patient health.
C. PhRMA’s Principles
Against this backdrop, the Principles were
approved by PhRMA’s Board of Directors on
July 29 and go into effect in January, 2006. The
Principles recognize that FDA regulations
already require that DTC ads be accurate and
not misleading, should make claims only when
supported by substantial evidence, should
reflect a balance between risks and benefits,
and should be consistent with FDA-approved
labeling. The Principles, and a question-andanswer section included with them, go further
and suggest that signatory companies implement the following steps, among others:
• Educate health care professionals for an
“appropriate amount of time” about new prescription drugs or new therapeutic indications
for prescription drugs before commencing the
first DTC ads. These educational efforts are
intended to provide health care professionals
with information about these new drugs or new
uses to foster responsible communication with
patients likely to have questions generated by
DTC advertisements. Companies are also to
continue these educational efforts upon receipt
of additional, valid and reliable information
regarding these drugs;
• Submit all new DTC television ads to the
FDA a reasonable time before they are broadcast, and inform FDA of the earliest date the ads
are scheduled to air (note, however, that the
Principles do not require, and the law does not
permit, FDA to pre-approve the content of such
ads);
• Ensure that DTC television ads for a
named product state clearly the medical condition for which the drug has been approved for
use and the major risks associated with it;
• Ensure that DTC television and print ads
state in clear, understandable language the risks
associated with use of a drug, and, working
September 2005
with FDA, alter or pull DTC ads when new and
reliable information indicates a serious, previously unknown safety risk;
• Target DTC print and television ads to
avoid age-inappropriate audiences (e.g., television ads for erectile dysfunction drugs should be
aired only when the audience is approximately
80% adult);
• Establish internal processes to ensure compliance with the Principles.
Under the Principles, PhRMA will also establish an Office of Accountability to receive comments from the public and health care
professionals regarding DTC ads by any signatory company, which includes any company
which publicly states it will follow the Principles. The Office of Accountability will provide
compliance guidance and will issue periodic
reports regarding DTC advertising. In January,
2007, the Office of Accountability will appoint
an independent panel to review the prior year’s
reports, examine industry trends relating to the
Principles, and make recommendations for
future action.
D. What’s Next?
Businesses in the life sciences field should
pay close attention to the Principles and to the
DTC issue in general. Even though the Principles will be followed by many PhRMA members,
important
interpretative
and
implementation issues remain. For instance,
there is no set period over which a company
must educate health care professionals before
broadcasting DTC ads, a recurring Congressional concern. The Principles suggest that the
“appropriate time” is to be determined by each
company in light of factors identified in the
Principles, including the importance of alerting
patients to the availability of the drug, the complexity of the drug’s risk-benefit profile, and the
health care field’s knowledge of the condition
being treated.
Nor is it possible to predict Congressional or
governmental response to the Principles, and in
particular, what effect they may have in forestalling further action by Congress or the FDA.
For its part, the FDA is expected to begin a
major regulatory review governing DTC advertising. Indeed, Lester Crawford, the new head
of the FDA, recently announced that he will be
holding public hearings this Fall in Cambridge,
Massachusetts, Florida, and Arizona in which
the FDA is expected to elicit public comment on
DTC ads. Crawford believes DTC ads can be
beneficial, but is reportedly weighing whether
clearer guidelines are in order.
There is also reason to question whether the
Principles go far enough. Already, two prominent PhRMA members have pledged to do
more. Although the Principles do not call for a
moratorium on DTC ads for new drugs, BristolMyers Squibb has announced it will hold off on
DTC ads for at least one year following a new
product launch – and said so before the Principles were released. After publication of the
Principles, Pfizer announced it would not
begin DTC ads for new drugs for at least six
months.