Bayer’s Combination Product Under Investigation

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Federal lawmakers are investigating advertising claims Bayer Healthcare, Morristown, NJ, has made on its Aspirin with Heart Advantage product, which combines 81 mg of aspirin and 400 mg of phytosterols.

The company’s marketing appears to go against FDA requests not to advertise these types of products, which combine drug and dietary supplement ingredients, and “may mislead the public,” according to House of Representatives Energy and Commerce Chairman John Dingell and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak, who issued a letter to Bayer HealthCare president Gary Balkema.

The letter asks the company if it plans to seek FDA approval for its product and calls on the drug maker to offer 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,” the letter reportedly states.

The American Herbal Products Association called on FDA earlier this year to clarify its marketing policy for products that combine over-the-counter medicines and dietary supplements. In 2000 FDA began allowing foods that contain plant sterols to include claims on packaging that they can reduce the risk of coronary heart disease because of their possible impact on cholesterol.

Bayer maintains that its advertisements tell consumers to consult their doctors before using Bayer Aspirin with Heart Advantage and warns it does not replace cholesterol medications.

Of late, the Michigan lawmakers have stepped up efforts to investigate whether drug companies have misled the public through consumer-targeted advertisements. Other companies with ads under review include Pfizer, Johnson & Johnson, Merck & Co and Schering Plough Corp.


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