House Committee Says FDA Is Dropping the Ball

Questions Drug Industry's Influence on Website; Goes After Bayer Product

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WASHINGTON ( -- Leaders of the House Energy and Commerce Committee are stepping back into drug advertising, saying the Food and Drug Administration isn't doing its job properly. The committee questioned whether the drug industry had an improper role in creating an FDA website explaining DTC advertising. Further, it claimed the FDA hasn't taken action to stop Bayer HealthCare from advertising Bayer Aspirin With Heart Advantage.

In letters sent today, Committee Chairman John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairman of the committee's oversight and investigations panel, complained that the FDA isn't doing the kind of oversight it's supposed to be doing, and cited the two incidents as examples.

Conflict of interest?
One of the targets of the letters is an FDA website titled: "Be Smart About Prescription Drug Advertising." The Center for Science in the Public Industry has suggested there was a conflict because EthicAd, which created the site, is funded by Shaw Science Partners, a public-relations company that does work for the pharmaceutical industry.

One set of letters to EthicAd, Shaw Science and the FDA questions whether the site's content was unduly influenced by drug companies.

"FDA's website could be viewed as less of a guide to consumers and more a guide to advertisers with examples of proper and improper DTC ads," the letter says.

Questions about combination
The other letter questioned whether Bayer's advertising of its Bayer Aspirin With Heart Advantage, a product that combines an over-the-counter medicine and a dietary supplement, conflicted with the FDA's warnings against combining two such products.

The letter noted that in May 2000 the agency discouraged the marketing of combination products because the FDA doesn't generally determine the safety and effectiveness of dietary supplements.

The letters ask the FDA about whether it approved the marketing and asks Bayer whether it intends to seek to have the product approved as a drug and whether it has proof the product is effective. Neither Bayer nor the FDA immediately returned requests for comment.
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