Life Sciences

Congress investigating Bayer advertising claims

Pharma Compliance Alert, October 22, 2008

Representatives John Dingell (D-MI) and Bart Stupak (D-MI) continue to examine pharmaceutical direct-to-consumer advertising, this time taking aim at Bayer Aspirin with Heart Advantage.

Bayer claims the product reduces the risk of heart attack by up to 30% and contains a natural plant-based supplement clinically proven to lower bad (LDL) cholesterol, which may help reduce the risk of heart disease.

Dingell and Stupak want to know why Bayer ignored the FDA’s 2000 warning not to promote products that combine over-the-counter drugs and dietary supplements because the addition of the supplement could affect the safety and effectiveness of the drug. In a letter to Bayer President Gary Balkima, the representatives requested copies of documents relating to claims about the supplement and the combination product as well as results of all studies.

In a separate letter to HHS Commissioner Michael Leavitt, Dingell and Stupak asked whether the FDA:
  • Knew about Bayer’s product in advance of the marketing
  • Knows about any other combination products being marketed
  • Has made any recent decisions regarding the marketing of combination products

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