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"Asking the industry to talk about the risks in a more
consumer-friendly way is just enlightened," he added. "Consumers
want these ads, refer to them and rely on them, so if they talk
about benefits and side effects in language most people can
understand, consumers can adequately discuss the drugs with their
Daniel L. Jaffe, executive vice president of the Association of
National Advertisers, who is the head of its Washington office,
echoed that praise.
"We're pleased the F.D.A. is now focusing on consumer
comprehension rather than believing that providing an enormous
amount of data will somehow solve the problem," he said. "The
consumer may be overwhelmed by the information, which is really set
up to educate doctors."
That was a reference to the fact that the patient information in
print ads often repeats verbatim the material on product risks that
drug makers provide to health care professionals.
"Though the ads provide everything you want to know about the
drug, the type is so small it's off-putting," said Val DiFebo,
managing partner at Deutsch in New York, an agency owned by the Interpublic
Group of Companies that creates campaigns for Novartis
prescription drugs like Lamisil, for toenail fungus, and Zelnorm,
for irritable bowel syndrome.
"The challenge to the advertiser, to the agency, is how to do it
in a way that energizes people to read the information, which is
communicated in a way they understand," she said.
Ms. DiFebo said she was not sure whether designing a print ad to
feature a boiled-down version of the risks inside a box was "the
right solution" because "the box could become a beacon: 'Everything
you don't want to read is in here.' "
John J. Beni, vice chairman at Parade Publications in New York,
the unit of Advance Publications that publishes the Sunday newspaper
magazine Parade, said it was too soon to assert what changes would
be the most effective.
"Let's figure out a way to redraft the ads so people will
actually read the stuff," Mr. Beni said, referring to the risk
information. He added that he was not worried that important data
was "going to go away" as a result of the proposed changes.
Nor is Mr. Beni concerned, he said, that any revisions will
result in "more or less revenue" for Parade, adding: "The question
is, How can drug makers communicate better in print? If they can
communicate better, maybe they will communicate more."
Parade will sponsor a conference in New York on Tuesday to
discuss the proposals, at which executives from two agencies
specializing in drug campaigns are to display examples of what ads
based on the new guidelines may look like.
Another proposal made by Dr. McClellan yesterday involves the
regulation of commercials known as reminder ads, which promote drugs
by brand name but do not mention the ailments they treat. Under
current rules, such commercials can run without describing the
Some drug makers have capitalized on that by closely preceding or
following reminder ads with other ads that discuss the need to treat
certain ailments without mentioning drugs by brand name. Those
commercials, too, can run without risk disclosures.
The proximity of the two types of commercials - paired as
bookends, as they are called - has been attacked by critics as
The proposals envision regulating bookends, possibly using
criteria like how much time separates the two types of ads and
whether viewers consider them "perceptually distinct" or
A third proposal from Dr. McClellan calls for rules for
commercials that promote major medical devices like pacemakers,
which are becoming more frequent and are not regulated.
The proposal would require a prominent statement of substantial
product risk and would require that viewers be directed to other
sources of risk information, like print ads.