Wyeth Pharmaceuticals has pleaded guilty to misbranding a drug that prevents the rejection of organ transplants and agreed to pay USD 490.9 million, the US Justice Department said today.
The USD 490.9 million will resolve Wyeth's criminal and civil liability stemming from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the US Food and Drug Administration.
Wyeth was acquired by US drug giant Pfizer in 2009.
In 1999, Wyeth received approval from the FDA for Rapamune use in renal, or kidney, transplant patients. The immunosuppressive drug prevents the body's immune system from rejecting a transplanted organ.
Wyeth was accused of training its Rapamune sales force in the United States to promote the use of the drug in non-renal organ transplants and encouraged them to offer financial incentives to target all types of transplant patients to boost sales.
The FDA had not authorised the so-called "off-label" uses.
"This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties," Sanford Coats, US attorney for the Western District of Oklahoma, said in a statement.
Wyeth pleaded guilty to a criminal a misbranding violation and has agreed to pay a criminal fine and forfeiture totalling USD 233.5 million, the Justice Department said.
The company, under a plea agreement that has been accepted by the US District Court in Oklahoma City, also has agreed to pay a criminal fine of USD 157.58 million and forfeit assets of USD 76 million.
