AstraZeneca, the British drugmaker with its American headquarters in Wilmington, Del., has agreed to a $520 million civil settlement over allegations that it illegally marketed its antipsychotic drug Seroquel for uses that were not approved by the U.S. Food and Drug Administration.
U.S. Attorney General Eric Holder said, the civil penalty was the “largest amount ever paid by a company in a civil-only settlement of off-label marketing claims.”
The initial allegations were filed in a whistleblower lawsuit brought under the False Claims Act. It alleged that between January 2001 and December 2006, AstraZeneca marketed Seroquel to doctors for Altzheimer’s disease, anger management, aggression, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, post-traumatic stress disorder and sleeplessness. Companies are not allowed to market drugs for so-called “off-label” uses, although doctors are allowed to prescribe drug for those conditions.
The case was pursued by the U.S Attorney’s Office for the Eastern District of Pennsylvania in , which announced the settlement.
“When pharmaceutical companies interfere with the FDA’s mission to insure that drugs are safe and effective, they … put the health and safety of patients at risk,” said U.S. Attorney Michael L. Levy in a statement. “People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues.”
In a release, the company acknowledged that it had entered the settlement and that in addition to $520 million civil penalty that would be shared with state governments, the company would enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. As part of that agreement, AstraZeneca will post on its website information about payments it makes to doctors, including money for speeches, other honoraria, travel, and lodging expenses.
AstraZeneca also faces thousands of personal injury lawsuits from people who took the drug alleging that they were harmed by it. In March, the company won a defense verdict from a New Jersey jury in the first Seroquel case to go to trial.
Last month, Horsham Pa.-based Institute for Safe Medication Practices said that between July and September 2009, the FDA got nearly 1,000 reports of serious, disabling, or fatal events that were linked to this medicine. ISMP said that most of those report were patients who became diabetic while taking the drug. According to the reports sent to the FDA, patients on the drug, whose generic name is quetiapine, more often become diabetic than people with similar risks of the condition who take other medications.
In 2009, Seroquel generated $4.2 billion in U.S. sales, according to IMS Health, which tracks prescription drug sales. The drug ranked fifth in drug sales in the U.S., according to IMS which has a regional headquarters in Plymouth Meeting, Pa.