Pfizer’s Wyeth has consented to pay $491m in fine for unlawful marketing of its kidney drug Rapamune, an FDA-approved immunosuppressant drug used to prevent rejection in organ transplantation.
In order to boost Rapamune sales, the company promoted the use of the drug in non-renal transplant patients by encouraging sales force members, through financial incentives, to target all transplant patient populations.
Between 1998 and 2009, Wyeth violated the False Claims Act by encouraging the use of Rapamune in combination with other immunosuppressive agents not listed on the label.
US Justice Department civil division acting assistant attorney general Stuart Delery said the FDA's drug approval process ensures companies market their products for uses proven safe and effective.
"We will hold accountable those who put patients' health at risk in pursuit of financial gain," Delery added.
The company has now pleaded guilty and agreed to settle all its criminal and civil liabilities arising from the off-label marketing of Rapamune.
Wyeth agreed to pay a criminal fine of $157.58m and forfeit assets of $76m, apart from paying $257.4m for resolving civil liabilities with the federal government and the states.
