The Food and Drug Administration has criticized an
advertisement for making "false or misleading safety claims that minimize the risks" of the cholesterol drug Crestor.
Accusing AstraZeneca of misbranding Crestor, the agency told the company to stop publishing the ad. But the agency's request appears moot: the ad ran for only several days in several major newspapers in late November.
The company launched the ads Nov. 23 in response to comments by an FDA researcher, Dr. David J. Graham, at a Senate Commerce Committee hearing. Although the hearing focused on the FDA's response to
withdrawing Vioxx from the market, Graham, a longtime critic of Vioxx, said several other drugs still on the market posed risks to patients. He identified Crestor as one of the drugs.
AstraZeneca immediately defended the product, citing clinical trials and comments from higher-ranking FDA officials that the drug is safe. But the company also ran ads to dispel what a spokeswoman said was "a great deal of misinformation."
The ad campaign was immediately attacked by Public Citizen, a consumer group that has petitioned the FDA to ban Crestor, alleging that the drug's side-effect risks outweigh its benefits. Public Citizen petitioned the FDA on Nov. 24 to halt the ads because they were "false and misleading."
The FDA agreed with Public Citizen. In a letter sent to AstraZeneca on Tuesday and published Wednesday on the agency's Web site, the FDA criticized several elements of the ad, including the passage that said, "The FDA has confidence in the safety and efficacy of Crestor."
The agency noted that public comments by top FDA officials include the remark by one that the FDA "has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."
Kellie Caldwell, a spokeswoman for AstraZeneca, said Wednesday that "we stand by the information contained in the ad. We stand behind Crestor." Caldwell said the ad ran on Nov. 23, 24 and 29, adding that AstraZeneca told the FDA on Dec. 2 that the ad no longer was being published.