Psychiatr News December 2, 2005
Volume 40, Number 23, page 1
© 2005 American Psychiatric Association
FDA Reviews Rules Governing Drug Ads For Consumers
Rich Daly
The $4 billion spent annually to market prescription drugs to the public
is under regulatory scrutiny for the first time in nearly a decade.
The Food and Drug Administration (FDA) is considering whether to modify its
policy on direct-to-consumer (DTC) advertising, which was relaxed in 1997,
prompting an advertising explosion. Many physicians maintain that the ads need
to be improved.
The 1997 policy change led to a marketing explosion, with pharmaceutical
ads promoting prescription products on television and radio, in print, and on
the Internet estimated to cost at least $4 billion annually.
During public hearings on the issue in November in Washington, D.C.,
physicians and public-health advocates told regulators that the ads can be
informative at their best and create unwarranted demands for drugs at their
worst.
Joseph Cranston, Ph.D., director of Science, Research, and Technology at
the AMA, testified that DTC advertising has been a topic of debate among his
organization's membership, which is considering recommending a ban on such
ads.
However, it remains unclear whether the FDA has the authority to impose
such an advertising moratorium, according to Robert Temple, M.D., director of
the Office of Medical Policy at the FDA's Center for Drug Evaluation and
Research.
Some legislators already support a moratorium. Prominent among them is
Senate Majority Leader Bill Frist (R-Tenn.), who said he would back a two-year
moratorium. The Pharmaceutical Research and Manufacturers of America (PhRMA)
said that beginning in 2006 its members will voluntarily delay broadcast ads
of new products for six months after introduction. The policy does not apply
to print ads.
Current FDA regulations require ads to be submitted for review at some time
during an ad campaign. In 2004, 586 TV ads and 52,848 other types of
promotions were submitted to the agency. Consumer advocates urged the FDA to
change its policy to require agency clearance of an ad before it is broadcast
or printed.
Revisions in FDA policy are unlikely to come until next spring, while the
agency continues to accept comments on the issue through the end of February
2006, according to regulators.
The range of issues at the November public hearing included industry
groups' claims that the DTC advertising of prescription drugs can lead to
better health care and consumer groups' suggestions that they can mislead the
public.
Drug makers defended the ads, saying that they motivate people to seek a
doctor's help. J. Patrick Kelly, president of Pfizer U.S. Pharmaceuticals,
said that 65 million people have talked to a doctor as a result of the ads and
that 29 million had discussed a condition for the first time, according to a
study by Prevention magazine.
DTC ads have been under scrutiny since the fall 2004 recall of Vioxx, due
to risk of cardiac complications. The drug was heavily promoted to consumers,
with the manufacturer, Merck & Co., spending up to $160 million annually
on such Vioxx ads.
DTC ads are acceptable, Cranston said, when they enhance patient education
about medical conditions, balance their presentation of the drug's risk with
its benefits, facilitate physician/patient communication, and are withheld
from release until physicians have been educated about a new drug.
But several studies have raised serious questions about the negative
aspects of DTC ads, such as lack of information on the condition the drug aims
to treat, using emotional appeals, and presenting inflated benefits of the
drug.
"These studies raise the question of whether commercially driven
direct-to-consumer ads are as informative as they need to be," Cranston
said.
Cranston said research has found that the ads tend to improve communication
between physicians and patients, but a subset of patients will insist a
physician prescribe a specific drug due to advertising they saw.
When asked by an FDA official how to improve the balance between the
presentation of risks and benefits in television ads, Cranston said regulators
should seek consultants to suggest guidelines to encourage a balance.
The AMA is preparing a report on the ads and will consider recommendations,
including two calling for ad bans, in June 2006.
Temple said the FDA is not considering changes to the advertising
requirements for direct-to-physician advertising, which is estimated to exceed
$5 billion annually.
PhRMA advertising principles are posted at
<www.phrma.org/publications/policy/admin/2005-08-02.1194.pdf>.
Related Article:
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Pay for Performance Raises Anxiety Level at AMA
- Mark Moran
Psychiatr News 2005 40: 8.
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