Lawmakers question ads for Bayer “herbal” aspirin

By Susan Heavey

WASHINGTON (Reuters) - Democratic lawmakers are expanding a probe into direct-to-consumer drug advertisements to include Bayer AG’s combination aspirin product, according to letters released on Tuesday.

Bayer’s marketing of its Aspirin with Heart Advantage, a combination product that includes a dietary supplement, appears to go against a U.S. Food and Drug Administration request not to advertise such products, said House of Representatives Energy and Commerce Chairman John Dingell.

Advertising the product to consumers “may mislead the public,” Dingell wrote along with Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak.

“The FDA strongly recommends that firms refrain from marketing products that combine or co-package drug and dietary supplement ingredients,” but would be willing to review them for possible approval, then-Associate Commissioner for Policy Margaret Dotzel said in May 2000.

While aspirin is FDA-approved, dietary supplements such as vitamins and herbs are not subject to agency scrutiny before marketing.

In the letter to Bayer, HealthCare President Gary Balkema, Michigan Democrats Dingell and Stupak asked whether the company planned to seek FDA approval for the combination product. They also called on the company to provide lawmakers with all related records within two weeks.

“The Committee is concerned that your company engaged in DTC (direct-to-consumer) advertising of this product, particularly in light of FDA’s recommendation to refrain from marketing combination products,” they wrote.

Bayer, in a statement, said its advertisements tell consumers to consult their doctors before using Bayer Aspirin with Heart Advantage and warns it does not replace cholesterol medications. The drugmaker added it was reviewing the lawmakers’ letter.  Continued…

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