AstraZeneca settles for $520 million following investigation into improper marketing of anti-psychotic drug
Pharmaceutical giant AstraZeneca has agreed to pay $520 million to end a federal investigation into its alleged illegal marketing of the drug Seroquel for off-label uses, according to reports from Washington.
The Justice Department has accused AstraZeneca of misleading physicians by emphasizing research favorable to Seroquel, and downplaying potentially dangerous side effects, such as diabetes and increased risk of death for elderly patients with dementia, according to The New York Times. Though it is not illegal to use drugs for off-label purposes, it is illegal to market them for those uses. A 2009 study found that as many as 20% of physicians who prescribed Seroquel for dementia treatment were unaware that the drug hadn't been approved for that use. (McKnight's, 8/26/09)
In October of last year, AstraZeneca set aside $520 million in an agreement with the United States attorney in Philadelphia, according to the Times. AstraZeneca made $4.9 billion in sales of Seroquel in 2009. The company has denied all allegations of wrongdoing. Off-label refers to the practice of prescribing a drug for a purpose other than what it was approved for by the Food and Drug Administration.