NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

Dingell, Stupak on FDA's Warning Letter on Bayer Aspirin with Heart Advantage

Washington, D.C. – Today, two weeks after the Committee on Energy and Commerce launched an investigation into the safety and effectiveness of Bayer Aspirin with Heart Advantage, the Food and Drug Administration (FDA) warned that the drug has not been approved and cannot be marketed legally. FDA also warned that Bayer's product is improperly labeled for use in reducing the risk of heart disease, as it has not been approved for that purpose.

Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of its Subcommittee on Oversight and Investigations, announced that the Committee will continue its investigation into the marketing of Bayer's over-the-counter product.

"Our investigation will continue,” said Dingell. “We remain curious as to why Bayer, in light of previous, well-publicized FDA decisions on such combination products, decided to market its product without prior FDA approval."

“The FDA appears to have responded to our investigation with appropriate action against Bayer Aspirin with Heart Advantage,” said Stupak. “While we appreciate the warning letter being sent, the FDA should not rely solely on Congressional oversight to notify them of such concerns. We need an FDA that is proactive rather than reactive when it comes to protecting public health.”

The Committee on Energy and Commerce began investigating misleading and deceptive direct-to-consumer (DTC) advertising in January 2008. Both the Lipitor ads featuring Dr. Jarvik and the Vytorin “Food and Family” ads were voluntarily withdrawn shortly after the investigation began.

On October 14, 2008, Chairmen Dingell and Stupak sent a letter to Gary S. Balkema, President of Bayer HealthCare LLC, questioning the safety and effectiveness of Bayer Aspirin with Heart Advantage, which claims to be both an over-the-counter medication as well as a dietary supplement, and why the company has ignored FDA recommendations to refrain from marketing such combination products. The Chairmen also wrote to Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services (HHS), inquiring whether the FDA has changed its position on such combination products.

Click here to read letter to HHS
Click here to read letter to Bayer HealthCare LLC

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