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House Democrat Henry Waxman (D-Calif.) has asked the Food and Drug Administration (FDA) to crack down on the maker of the cholesterol-lowering drug Crestor® for what he calls misleading advertising on its website and in national newspapers.
Dr. David Graham, FDA drug safety officer, recently named CRESTOR® as one of five potentially hazardous drugs in his testimony to Congress. AstraZeneca, which manufactures and markets CRESTOR®, responded with full page advertisements in national and regional publications, including The Wall Street Journal, The Washington Post, The New York Times, and USA Today that said, "The FDA has confidence in the safety and efficacy of Crestor®."
Rep. Waxman, the ranking Democrat on the House Committee on Government Reform, said in a letter to the FDA that AstraZeneca's advertising conflicts with the FDA's public statements about the drug. He has asked the FDA to review the advertisements and order them to post a correction if the statements are false.
Waxman goes on to say that AstraZeneca's statement on its website says "that the company has been assured that senior-level FDA officials have 'no concern in relation to Crestor's® safety,' which appears to conflict with the FDA statements on the drug." In his letter he points out a newspaper interview in which Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency "had been very concerned about Crestor® since the day it was approved, and we've been watching it very carefully."
FDA spokeswoman Kathleen Quinn acknowledged the agency has received Waxman's letter and the FDA "takes his concerns very seriously and will respond promptly."
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