FDA Issues Untitled Letter to AstraZeneca Over Crestor Promotion

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued AstraZeneca its second untitled letter in four months regarding promotional activities for the company's cholesterol-lowering drug Crestor.

The DDMAC's latest letter cited AstraZeneca for making misleading claims regarding the superiority of Crestor (rosuvastatin calcium) in a direct-to-consumer (DTC) advertising campaign that included both television spots and print ads. The DTC ads indicated that Crestor had an advantage over competing statin drugs based on the results of the STELLAR study (Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin). AstraZeneca includes the results of the STELLAR trial in Crestor's labeling.

"All cholesterol drugs simply aren't the same. When Crestor performed in a head-to-head test, its lowering effect was clearly the best," state the ads, which aired in 2004. The DDMAC took issue with the "clearly the best" line, saying the STELLAR data do not support such a claim for Crestor.

The DDMAC ordered AstraZeneca to immediately cease distribution of the promotional materials. To view the March 8 letter, go to http://www.fda.gov/cder/warn/2005/Crestor_letter.pdf (http://www.fda.gov/cder/warn/2005/Crestor_letter.pdf).