AstraZeneca, a pharmaceutical company, has reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its best-selling psychiatric drug Seroquel. According to research firm IMS Health, Seroquel was the top selling anti-psychotic medication in 2004 with about $17 billion in sales. AstraZeneca joins a list of drug manufacturers forced to pay billions of dollars to settle inquiries filed by former company insiders.
AstraZeneca disclosed one of the investigations related to physicians who participated in clinical trials involving Seroquel and another related to off-label promotion of the drug. However, a company spokesman refused to give more specifics about the physicians or clinical trials under investigation. He also said the company was in final negotiations to settle the whistle-blower lawsuits and reach a corporate integrity agreement with the U.S. Justice Department.
As a result to the company’s aggressive marketing campaign, Seroquel has been used for children and elderly patients for indications not approved by the Food and Drug Administration (FDA); doctors are allowed to prescribe any approved medication for off-label uses. AstraZeneca has also said that as of October 9, it has been served with 14,444 civil lawsuits over Seroquel’s misleading marketing because many of the patients using the drug have developed diabetes and other health problems.