FDA holds hearing for DTC guidelines

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Pharmaceutical companies and their agencies could be operating under new Food and Drug Administration guidelines before the end of the year. The FDA will hold a two-day public meeting beginning today in Washington D.C. to hear both sides of the direct-to-consumer advertising argument before issuing new guidelines.

"DTC ads are one factor that helps get people into the doctor's office," FDA Commissioner Dr. Mark McClellan said Sept. 10 at a private luncheon in New York hosted by Hearst Magazines' Good Housekeeping. "There's a lot of good. But there's also a lot of concern. There's a fine line there, as there is in everything. But through enforcement, companies get a better idea of where the line is."

under microscope

The pharmaceutical industry has been under the microscope in part because the FDA has been under some scrutiny itself. Last year, the General Accounting Office issued a report that criticized the FDA for taking too long to review claims made in DTC advertising.

Dr. McClellan said many of the concerns will be addressed in the public forum this week, but he also made it clear that DTC advertising is here to stay. Drug companies, he noted, spent more than $2.5 billion on DTC ads last year, "but that was still only 10% of what the [overall] spending was in the industry." For example, pharmaceutical companies spent $32 billion last year just on research and development.

"Our concern right now is that [the drug companies] are not relating what the full picture is in terms of risk vs. benefit," Dr. McClellan said.

The move comes as the FDA is more closely scrutinizing drug ads. Of 18 warning letters sent by the FDA this year, seven were for DTC ads. Two were sent within 22 days of each other last month to major pharmaceutical companies that were asked to pull their advertising-one to Bristol-Myers Squibb for a misleading print ad for Pravachol, and the other to Novartis for a TV spot for Lamisil.

FDA issues

In reprimanding the pharmaceutical companies for the Lamisil and Pravachol ads, the FDA took issue with what it called misleading claims of efficacy and for targeting illnesses and ailments for which the drugs had not been approved. In the case of the anti-cholesterol Pravachol, the FDA also asked for "prompt dissemination" of corrective ads.

Novartis and its agency, Interpublic Group of Cos.' Deutsch, New York, declined to comment, although a Deutsch spokeswoman did say the TV ads for Lamisil were scheduled to end in September.

Bristol-Myers Squibb would only say that it is continuing to work with the FDA to resolve the issue. No corrective ads have been produced as of yet. The agency for Pravachol, Havas' Euro RSCG Life Becker, New York, did not return a call.

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