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FDA writes to AstraZeneca regarding Crestor advertisements

ROCKVILLE, MD., March 14, 2005 -- The Food and Drug Administration posted a copy of a letter sent to AstraZeneca Pharmaceuticals LP regarding direct-to-consumer advertisements for the drug Crestor. The letter followed a review by the afency's Division of Drug Marketing, Advertising, and Communications (DDMAC), in consultation with the Division of Metabolic and Endocrine Drug Products (DMEDP), of a direct-to-consumer television advertisement and three DTC print ads for Crestor (rosuvastatin calcium) Tablets, submitted by AstraZeneca Pharmaceuticals LP under cover of Form FDA 2253 (ID# 223151, 223444, 224174, and 225058).

According to the letter, the TV ad and the STELLAR print ads make false or misleading claims regarding the superiority of Crestor. The TV and print ads thus misbrand Crestor in violation of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 352 (n)); 21 CFR 202.1(e)(6) (ii).

Frames 10-14 of the TV ad and each of the STELLAR print ads present a bar graph purportedly based on the STELLAR study. In conjunction with the bar graph, the ads make the following comparative claims:

All cholesterol drugs simply aren't the same. When Crestor performed in a head to head test its lowering effect was clearly the best. (TV ad)

Cholesterol high? Trouble getting it low? Perhaps your answer is right here, below. (print ad)

Lowering cholesterol isn't a game. It's vital to know not all drugs are the same. (print ad)

Is your cholesterol treatment doing its share? Are you where you should be? If not, then compare. (print ad)

In the TV ad and STELLAR print ads, the graph is titled THE STELLAR STUDY Bad cholesterol (LDL-C) lowering effect and shows LDL-C lowering from baseline for Pravachol 40 mg (30%), Zocor 20 mg (35%), Lipitor 10 mg (37%), and Crestor 10 mg (46%). Below the graph in the TV ad are small SUPERs Most commonly Rx'd doses (August 2003-July 2004) and Your results may vary. Below the graph in the STELLAR print ads is a small SUPER Your results may vary and the text below the graph states In the STELLAR study, the usual starting dose of Crestor was more effective at lowering bad cholesterol than the most common doses of the other leading medications.

The FDA says the presentation is a misleading comparison because it relies solely on data that are not relevant to comparisons of the drugs such as most common dose or starting dose, while ignoring data that do not support the claim of superiority made in the ads. Specifically, the comparison with Lipitor is misleading because it suggests that Crestor is superior to Lipitor when in fact none of the approved doses of Crestor was significantly superior to 80 mg of Lipitor in the STELLAR study. The STELLAR study itself states The best LDL cholesterol reduction (55%) was achieved in the rosuvastatin 40-mg group and was not significantly different from the next highest LDL cholesterol reduction (51%) observed in the atorvastatin [Lipitor] 80-mg group (emphasis added).1 Moreover, the 10 mg dose of Crestor was not statistically significantly more effective at LDL-C lowering than Lipitor 20 mg or 40 mg. Comparison of the most common doses or starting doses is irrelevant to the actual effectiveness of the drugs. Starting and common doses reflect a variety of influences, including doses studied in trials, commercial considerations, and toxicity concerns; however, they do not represent factors that are relevant for comparative effectiveness. Accordingly, your suggestion that Crestor is superior to Lipitor is therefore misleading. 21 CFR 202.1(e)(6)(ii).

DDMAC requested that AstraZeneca immediately cease the dissemination of violative promotional materials for Crestor such as those described in the letter and ensure that promotional materials for Crestor comply with each applicable requirement of the Act and FDA implementing regulations.

Source: FDA

Posted: March 2005

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