ASTRAZENECA GETS LETTER FROM DDMAC OVER CRESTOR DTC ADS

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to AstraZeneca for safety claims about the company's cholesterol-lowering drug Crestor that the agency has deemed false or misleading.

In the untitled letter, DDMAC takes issue with a direct-to-consumer (DTC) print ad for Crestor (rosuvastatin calcium) that appeared in the Washington Post Nov. 23 and in other major metropolitan newspapers, including the New York Times, the Wall Street Journal, USA Today and the Los Angeles Times.

The DTC ad says consumers "can be assured that at AstraZeneca, patient safety is our number one priority" and seeks to assure them that Crestor is "more effective and just as safe" as "the leading medications in its class."

AstraZeneca's "patient safety" ad violates the Federal Food, Drug, and Cosmetic Act by making false or misleading safety claims that minimize the risks associated with Crestor, and by suggesting that the drug is safer than has been demonstrated by clinical evidence, DDMAC said in the untitled letter. The FDA is not aware of substantial evidence showing that all doses of Crestor are "just as safe" as other statins, DDMAC added.

Also of concern to DDMAC was a section of the ad that says the FDA "has confidence in the safety and efficacy of Crestor," and that the agency states on its website that concerns raised about the product "have no medical or scientific basis." According to DDMAC, however, no such statement appears on the FDA's website, and recent public statements by the agency contradict the drugmaker's assertion.

To view the untitled letter, go to http://www.fda.gov/cder/warn/2004/12779.pdf (http://www.fda.gov/cder/warn/2004/12779.pdf).