Wyeth fined $540m for illegal marketing

The $541.71 million will resolve Wyeth's criminal and civil liability stemming from the unlawful marketing of the drug sirolimus (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 sirolimus use in renal transplant patients. In Australia it is PBS listed for the prophylaxis of renal transplant rejection. 

Wyeth was accused of training its sales force in the US 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 approved these 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," said Sanford Coats, US lawyer for the