Bayer ignored FDA; Congress asks why

The FDA warned Bayer Healthcare about marketing a product called "Bayer Aspirin with Heart Advantage" as safe and effective, but it appears that Bayer completely ignored the warning and the House Energy & Commerce Committee wants to know why. The product in question contains aspirin in addition to a dietary supplement that purports to lower cholesterol. 

The FDA only regulates the aspirin part of the combination; nevertheless, it sent a letter to the president of Bayer requesting all studies showing the product did indeed have a heart advantage. Bayer claims the supplement can lower cholesterol, but didn't prove it--nor did the company heed the FDA's warning. Instead, Bayer went ahead with direct-to-consumer marketing of its product. Mike Leavitt, U.S. Health & Human Services Secretary, received a letter as well, specifically asking what the FDA has done about the marketing.

- see the Pharmalot blog post

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