Astra Zeneca to Settle Case for $520 Million

The Department of Justice plans a news conference on Wednesday to reveal details of the case, according to two people close to the negotiations who were not authorized to discuss it publicly.

AstraZeneca will sign a corporate integrity agreement with the federal government over its aggressive marketing of Seroquel for unapproved uses, but will not face criminal charges, the people said. The company, based in Britain, has been accused of hiding evidence that Seroquel increases the risk of diabetes.

The deal would make formal an agreement in principle the company reached last October with the United States attorney in Philadelphia. At that time, AstraZeneca said in a filing with the Securities and Exchange Commission that it had set aside $520 million in respect to the investigation.

The company was facing two federal investigations and two whistle-blower lawsuits involving Seroquel sales and marketing practices. One of the investigations related to physicians who participated in clinical trials, the other to sales staff, and details are expected to be revealed this week.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. Doctors are permitted to prescribe any approved drug for off-label uses.

Tony Jewell, a company spokesman, declined to comment on Monday. Patricia Hartman, a spokeswoman for Michael L. Levy, the United States attorney in Philadelphia, said she would neither confirm nor deny the report. “We don’t have anything public on AstraZeneca,” Ms. Hartman said.

AstraZeneca, which reported $4.9 billion in Seroquel sales in 2009, plans to report its first-quarter financial results on Thursday.

The company will join a series of American pharmaceutical companies that have admitted to illegal marketing after federal investigations and whistle-blower filings and have signed agreements with the government to monitor and avoid such activity in the future. Pfizer paid $2.3 billion and Eli Lilly paid $1.4 billion to settle similar cases.

AstraZeneca also faces thousands of civil lawsuits over Seroquel. It was accused of hiding the risk of diabetes and other health problems for people who take the drug.

via nytimes.com

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