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Belch: Advertising and
Promotion, Sixth Edition
IMC PERSPECTIVE 21-3
VII. Special Topics and
Perspectives
21. Regulation of
Advertising and Promotion
© The McGraw−Hill
Companies, 2003
The Debate over Direct-to-Consumer Drug Advertising
For years, pharmaceutical companies did most of their
prescription-drug marketing directly to physicians,
either through their sales forces or by advertising in
medical journals. However, in 1997 the Food and Drug
Administration (FDA) issued new guidelines making it
easier for pharmaceutical companies to advertise prescription
drugs on television as well as in print media.
With the change in guidelines, direct-to-consumer
drug advertising has exploded, and pharmaceutical
companies are some of the largest consumer advertisers.
Brand name prescription drugs such as Prozac,
Viagra, and Claritin have become as well known to consumers
as brands of soft drinks.
Direct-to-consumer drug advertising spending
soared from $859 million in 1997 to $2.8 billion in
$2001. In recent years there has been a flurry of ads
hawking prescription drugs for a variety of medical
problems and conditions, including allergies, heartburn,
arthritis, depression, and impotence. Drug companies
use celebrities to pitch their products just as
effectively as other marketers do. A television commercial
for cholesterol drug Zocor features National
Football League coach Dan Reeves stating, “Taking
care of my cholesterol; it has become an important
part of my game plan.” Former figure skating champion
and Olympic gold medalist Dorothy Hammill talks
about experiencing the pain of osteoarthritis in a commercial
for Vioxx. Pfizer used former vice president
Bob Dole as an advertising spokesperson when it
launched Viagra in 1998 and now spends nearly $100
million a year to advertise the male impotence drug.
Texas Ranger’s baseball star Rafiel Palmeiro appears in
ads for the product, stating, “I take batting practice. I
take infield practice. I take Viagra.”
The pharmaceutical companies note that the
increased spending on drug advertising has helped
educate consumers about their options and has
caused people to see doctors about medications who
might not have done so otherwise. However, a number
of physician, consumer, and health care groups have
expressed concern over the increase in drug advertising
for several reasons. A major concern of these
groups is whether the ads are accurate and whether
they inform consumers of all the risks associated with
taking the drugs. Consumer groups have asked the
Food and Drug Administration to develop a process for
enforcement of the “fair balance” provision, an FDA
regulation governing broadcast commercials that
requires drug ads to give both the benefits and the
risks of taking a medication.
The FDA is charged with the responsibility of ensuring
that drug advertising is fair, balanced, and truthful.
However, the number of ads submitted annually for
FDA scrutiny, including TV spots, magazine ads, Internet
sites, and even pamphlets used by sales representatives,
has jumped nearly 35 percent over the past five
years, from just over 25,000 to more than 34,000. The
number of citation letters issue by the FDA to drug
companies for ads that might be false, misleading, or
otherwise out of compliance has been steadily declining,
as only 71 were sent out in 2001. The pharmaceutical
companies say that the drop in citations shows
that their advertisements are cleaner than before and
that the companies are much more knowledgeable
about the FDA guidelines than they were in 1997. However,
the FDA’s director of the Division of Drug Marketing,
Advertising and Communication notes that with
its limited resources the division cannot investigate
all of the ads so it focuses on ads deemed most critical—those
that appear on television, make unusual
claims, or raise a major public health issue.
Many watchdog organizations such as the Public Citizen’s
Health Research Group feel that the drug companies’
advertising and marketing pitches are not more
honest or balanced than they were in the past. They
argue that the FDA citations are little more than slaps
on the wrist to the powerful drug companies and that
the FDA has to be given the authority to levy stiff fines
against companies that repeatedly violate its guidelines.
Consumer advocates have also argued for stricter
regulations on drug ads, noting that while advertisers
must include statements about negative side effects or
toxicity, it is the dancing couples and happy images that
people remember—not the cautionary voiceover.
Another concern over the increase in prescriptiondrug
advertising has been raised by insurance companies
as well as employers, who feel that the ads are
driving up the costs of health care. These companies
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