The FDA has called AstraZeneca's recent full-page newspaper ads defending Crestor "false and misleading," because of lingering concerns about the drug's safety.
In a recent but undated letter sent to AZ from the FDA, federal regulators said the ad's claims that "the FDA has confidence in the safety and efficacy of Crestor," and "as recently as last Friday publicly confirmed that Crestor is safe and effective," are untrue.
In the days before the ad ran in publications including The New York Times, The Wall Street Journal, and USA Today in November, FDA officials were quoted as saying they had some concerns about the drug. However, AZ officials said this week that the company stands by the ads.
"We believe that our communication have been consistent with what has been communicated to us and with what clinical trials tell us and post-marketing data tells us," AZ spokeswoman Emily Denney told The New York Times. Denney said AZ stands behind the ads "and our communications around Crestor."
The campaign to defend Crestor began soon after FDA whistleblower David Graham told a Congressional panel that Crestor was one of five drugs currently on the market whose safety needed "to be seriously looked at."
And in the days following the first appearance of the ads, the consumer advocacy group Public Citizen called on AZ to pull them, also charging they made "false claims" about the FDA's safety concerns.
The ads for Crestor stopped running in late November, well before the receipt of the FDA letter, according to published reports.