01 Aug 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US Department of Justice revealed that Pfizer has agreed to pay $491 million to settle criminal and civil charges over the illegal marketing of the kidney-transplant drug Rapamune. The case revolves around the practices of Wyeth Pharmaceuticals, which was acquired by Pfizer during 2009.
Rapamune, which prevents the body's immune system from rejecting a transplanted organ, was approved by the US FDA in 1999 for use in patients receiving a kidney transplant. However, federal officials said that Wyeth aggressively promoted the drug for use in patients receiving other organ transplants, even offering financial incentives to its sales force to do so. Accusations of Wyeth's practices became public in 2010 after a whistle-blower lawsuit filed by two former employees was unsealed.
After lawmakers announced a Congressional inquiry, the Justice Department opted to join the lawsuit. The settlement also resolves a second, similar whistle-blower suit and includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia.
Mr Reuben A Guttman, a lawyer for two of the whistle-blowers, said the spate of pharmaceutical settlements in recent years had blunted reaction to what he said were shameful practices. "Everybody's been asking me why this case is different than any other," he said. "We used to trust these companies. You can't trust these companies anymore."
In a statement, Pfizer noted that it was not a target of the Justice Department's case, and said the company "cooperated fully with the government from the time it learned of this investigation in
October 2009. That cooperation was acknowledged today by the Justice Department."