WASHINGTON -- U.S. pharmaceutical giant Amgen has pleaded guilty to illegally introducing a misbranded drug for treating anemia onto the market and will pay a record $762 million fine, officials said Wednesday.
The Justice Department said the guilty plea was part of a settlement with the United States that "represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history."
The $762 million includes $612 million to resolve False Claims Acts suits and $150 million in criminal penalties and forfeiture, a statement said.
The drug in question is Aranesp, which the criminal plea agreement says Amgen illegally introduced for uses and at dosage levels that the Food and Drug Administration had specifically declined to approve.
"Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease," said Marshall Miller, acting U.S. attorney for the Eastern District of New York.
"Today's settlement demonstrates our vigilance in protecting America's healthcare consumers and pursuing any corporation that seeks to profit by violating U.S. law."
Copyright Agence France-Presse, 2012
