AstraZeneca Plc was reprimanded by the U.S. Food and Drug Administration for underplaying risks linked to its Crestor cholesterol drug in an advertisement.
The ad said the FDA is confident of Crestor’s safety and effectiveness. The U.S. drug regulator told the London-based company in a Dec. 21 letter posted online today to stop using the ad and asked for a list of publications in which it ran.
The advertisement “misleadingly suggests that the agency does not believe that Crestor poses safety concerns,” the FDA wrote in the letter. “In fact, recent public statements made by the agency contradict that conclusion.”
AstraZeneca Chief Executive Tom McKillop is under pressure to show that Crestor can sustain earnings growth after the company’s Iressa lung-cancer drug failed in a key study. The ad ran in the Washington Post Nov. 23, five days after FDA reviewer David Graham told a U.S. Senate hearing that Crestor should be re-examined because of a link to kidney damage in high doses.
“We had lots of calls into our patient and physician information lines, and we felt we had to set the record straight,” AstraZeneca spokeswoman Emily Denney said in a telephone interview today. “The ad was only ever intended to run for a couple of days.”
AstraZeneca’s American Depositary receipts fell 81 cents, or 2.2 percent, to $35.88 at 4:15 p.m. in New York Stock Exchange composite trading. Each ADR represents one ordinary share.
Competing With Lipitor
Crestor was introduced in August 2003 to challenge Pfizer Inc.’s Lipitor, the world’s best-selling drug, which generated $9.2 billion in 2003 revenue. The AstraZeneca product had 2004 sales of $596 million through Sept. 30.
The promotion appeared in publications including the New York Times, USA Today, the Philadelphia Inquirer and the Dallas Morning News, Denney said.
The FDA is under pressure from lawmakers and consumer groups who say it isn’t doing enough to police the safety of medicines after they are approved, such as Merck & Co.’s withdrawn Vioxx painkiller. A company study found that patients taking Vioxx for 18 months or longer had twice the risk of heart attacks and strokes as those on a placebo.
The agency on Dec. 17 asked Pfizer Inc. to halt advertisements for its Celebrex pain medication, which belongs to the same class of drugs as Vioxx, after a study suggested Celebrex may also carry a heart risk. Other Celebrex research has found the drug to be safe.
In its letter to AstraZeneca, the FDA stopped short of asking the company to publish corrections to the advertisement. The agency also didn’t issue a formal warning letter, which can trigger slowdowns in new drug approvals and other consequences. That suggests the letter was intended to keep AstraZeneca from making similar claims in the future, said Ira Loss, who follows the FDA and regulatory issues for Washington Analysis.
“There are many of these kind of letters written every year, and very few end up with real fallout,” Loss said. “The people who write those letters are not going to be the same people who decide whether Crestor has a good risk-benefit ratio.”
According to the FDA letter, the AstraZeneca ad claimed that “a medication can be more effective and just as safe.” The agency said, “This claim is misleading because it minimizes the risks associated with the 40 mg dose of Crestor. The FDA is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are `just as safe’ as other” drugs of its type.
Ad No Longer Running
The company told the FDA Dec. 2 that the ad was no longer running, Denney said.
“The communication in that ad is consistent with what has been communicated to us and what has been found in our post-marketing database, which shows the drug is safe and effective,” Denney said.
Like other cholesterol drugs in the same class, Crestor can cause rhabdomyolysis, which destroys muscle tissue and can lead to serious kidney damage.
AstraZeneca stopped testing the highest doses of Crestor during the medicine’s development after patients suffered kidney damage, and the FDA delayed the drug’s approval for a year to more closely evaluate potential risks.
Bayer AG, Germany’s second-biggest drug and chemical maker, withdrew its related Baycol cholesterol medication in 2001 after it was linked to rhabdomyolysis and has since agreed to pay more than $1 billion to settle about 2,700 lawsuits. Baycol was eventually linked to more than 100 deaths.