Congress presses FDA, Bayer on DTC info, OTC combos

Rep. Bart Stupak
Rep. Bart Stupak
Reps. John Dingell and Bart Stupak (both D-MI) wrote the FDA to question its use of a pharma PR firm in developing a website about DTC advertising for consumers.

Dingell, who chairs the Committee on Energy and Commerce, and Stupak, who chairs the Oversight and Investigations Subcommittee, said in a letter to FDA Commissioner Andrew von Eschenbach that an informational agency site for consumers on DTC ads “could be viewed as less of a guide to consumers and more of a guide to advertisers,” and demanded to know why FDA “sought the assistance of a pharmaceutical public relations firm to help it advise consumers on how to interpret DTC advertisements.”

The site, developed by Atlanta-based Shaw Science Partners and EthicAd, a nonprofit funded by the PR shop, is titled “Be Smart About Prescription Drug Advertising – What You Should Know About Prescription Drug Advertisements.” Dingell and Stupak noted that Shaw “worked on the launch of more than 30 drugs, including Procrit, whose DTC advertisements have been investigated by this committee, and Rezulin, a drug that was removed from the market for safety problems.” The congressmen demanded all records relating to the website, Shaw Science Partners and EthicAd, and communications with PhRMA about the website.

The congressmen also wrote the Department of Health and Human Services and Bayer to inquire about Bayer Aspirin with Heart Advantage. The drug, they said, seems to defy an FDA edict against marketing OTC medication/dietary supplement combos.

“Bayer Aspirin with Heart Advantage is such a combination product, but the company appears to have ignored FDA's recommendation to refrain from marketing such combination products,” said Dingell and Stupak.