FDA calls Crestor ads ‘false and misleading’

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.