HEARINGS ON $4 BILLION DTC INDUSTRY BEGIN

Pfizer Talks of Changes, Consumers Union Urges Reform

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WASHINGTON (AdAge.com) -- There were several dissonant voices during day one of the two-day public hearings on direct-to-consumer pharmaceutical advertising convened by the Food and Drug Administration that began today, but three things became clear.
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Change needed
First, supporters of DTC recognize change is needed and will bend -- but not too much. Second, opponents want complete reform of the $4 billion industry and are emboldened by a public and political climate that seems to favor them right now. And somewhere in between is an embattled FDA that knows it has to do something but isn’t quite sure it can do anything.

Nearly 20 speakers provided testimony for the FDA’s Center for Drug Evaluation and Research public hearings on Consumer Directed Promotion of Regulated Medical Products that conclude Nov. 2. The FDA panel stressed its goal was to gather information to answer pertinent questions surrounding DTC, including whether the presentation of risk and benefits is done in an accurate, balanced way; whether changes in the requirements for fair balance in TV advertising can be improved; and what action the agency should take if companies distribute materials to consumers that violate guidelines.

Calling for moratorium
Most of the speakers today were in support of DTC, but one group that isn’t scheduled to testify until tomorrow distributed an advance copy of a call for reform. Washington-based Consumers Union, the nonprofit publisher of Consumer Reports, in a release said: “Because the emphasis at the FDA is getting drugs quickly to market, the agency often doesn’t fully know the safety implications of some of these drugs.”

Consumers Union called for a two- to three-year moratorium on advertising new drugs; pre-approval of DTC and direct-to-physician ads; passage of Senate bill that calls for a public report that safety concerns have been identified and are being investigated; and other legislation that would give the FDA civil monetary penalty authority to enforce truth-in-advertising.

'Clearly bad ideas'
John Kamp, director of the Coalition for Healthcare Communication, testified that such quick fixes were “clearly bad ideas.” Mr. Kamp did note, however, that while DTC advertising “is the most regulated form of advertising in the U.S.,” it nonetheless is “more confusing than enlightening.”

The most influential speaker from day one was Pfizer’s president of U.S. Pharmaceuticals, J. Patrick Kelly. While agreeing that drug companies “can do more,” Mr. Kelly also said that “we believe under the First Amendment patients have a right to receive information and our companies have a right to impart it.” He spoke about Pfizer’s specific efforts that went beyond the voluntary code of conduct put in place in August by the Pharmaceutical Research and Manufacturers of America.

But two of his answers to direct questions from the FDA panel were spoken in generalities.

Enough risk information?
“Are patients not getting enough risk information?” asked Thomas Abrams, the FDA’s director of the Division of Drug Marketing, Advertising and Communications. “That’s a fair question and an important question,” Mr. Kelly replied. “It’s a determination of what is enough. Will we accept that a consumer understands there are risks inherent in any medication, or do we need them to recite specific side effects that might occur with that medication?”

Dr. Rachel Behrman, deputy director, Office of Medical Policy, asked Mr. Kelly if he “thought internally about the entire message of the ad and how do you ensure one part doesn’t obscure or dilute the other part?”

He replied: “That has to start with an understanding or appreciation of what is accomplishable in 60 seconds or 30 seconds of a TV ad, or a page or two if you’re talking about print advertising.”

Celebrity DTC ads
One of the more interesting presentations was from Dr. Abby Mehta, director of research and advertising for the marketing firm of Gallup & Robinson. One of the items on the FDA’s loose agenda was to hear testimony about the impact of celebrity endorsers of drugs. In a survey commissioned by Pfizer, Ms. Mehta testified that in a study done with fictitious brands of migraine and high-cholesterol medications (to ensure there was no prior knowledge of current brands) endorsed in fake ads by real celebrities, awareness among consumers of the faux celebrity print ads was 34% higher than that of ads featuring non-celebrities.

The awareness was higher for the migraine ads than the cholesterol promotions and the study was done as “day after recall.”

“On average,” Ms. Mehta said, “celebrity ads can and do show higher breakthrough [of clutter], gain attention and the spokesperson is rated more favorably than non-celebrities. But the celebrities, she said, were not seen to be providing any more important a message” than non-celebrities.

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