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. Addenda: Radio Ad Revenue Was 1% Higher in 2003 (February 5, 2004)



Food and Drug Administration

Drugs (Pharmaceuticals)


Marketing and Merchandising

Research Company

Proposed Changes to Ad Rules

Published: February 5, 2004

(Page 2 of 2)

"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 doctors."

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 drugs' risks.

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 exploitive.

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 intrinsically related.

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.

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