The Justice Department said Tuesday that drug maker Pfizer Inc. will pay almost $491 million to resolve an investigation into illegal marketing of the organ transplant drug Rapamune by a company Pfizer later acquired.
Pfizer had taken a charge to cover the settlement late last year, when it reached a tentative settlement to resolve lawsuits three whistle-blowers had filed in 2005 and 2007. The Justice Department and numerous other government agencies eventually joined in the probe and the lawsuits.
On Tuesday, New York-based Pfizer agreed to pay $257.4 million in civil settlements with federal and state governments and a $157.6 million criminal fine. Pfizer also will forfeit $76 million in assets.
The Justice Department said the drug maker Wyeth, which Pfizer bought in October 2009, trained sales representatives to encourage doctors to prescribe Rapamune for uses other than preventing rejection of transplanted kidneys, even giving them bonuses for doing so.
Rapamune was approved in 1999, only for use in kidney transplant patients. Federal laws bar drug makers from promoting drugs for uses not specifically approved by the Food and Drug Administration.
But the practice has previously been so rampant that there’s a term for it — off-label marketing — and multiple law firms specialize in pursuing lawsuits over it. Nearly every big drug maker, including Pfizer, has been prosecuted for it and eventually agreed to big settlements with the government and whistle-blowers.