FDA says Crestor ads are misleading; regulators say the pill is not necessarily best at lowering cholesterol

• For the second time in four months, the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications (DDMAC) has warned AstraZeneca on advertisements promoting its cholesterol drug Crestor--calling suggestions that the drug is better that Pfizer's Lipitor "misleading."
• A spokesperson for AstraZeneca (nyse: AZN - news - people) said the letter, a copy of which was obtained by Forbes.com, only applies to one ad campaign in the context of one specific portion of data from one study.
• AstraZeneca continues to believe that based on other comparative data it will be able to claim that Crestor is better at lowering bad cholesterol than all other statins.
• In a letter sent to AstraZeneca, an officer at DDMAC noted that the efficacy of Crestor's top 40-milligram dose was similar to that of 80 milligrams of Lipitor in the study referenced by AstraZeneca.
• "The TV and print ads make false or misleading claims regarding the superiority of Crestor," Christine Smith, a regulatory review officer at DDMAC wrote in the letter.
• "All cholesterol drugs simply aren't the same," one ad intoned, according to the letter.
• Print advertisements made their own rhyming claims.
• If not then compare," says a third.
• Pfizer's (nyse: PFE - news - people) Lipitor rules the cholesterol market and is prescribed more than all other similar drugs combined.
• Merck (nyse: MRK - news - people) and Schering-Plough (nyse: SGP - news - people) have introduced their own drug, Vytorin, which gets efficacy by combining Merck's Zocor with another cholesterol-lowering drug.
• Crestor, meanwhile, has been faced with critics who say it may not be as safe as its competitors--claims with which AstraZeneca and some researchers vigorously disagree but which have had a noticeable affect on sales.