MANHATTAN (CN) - Wyeth Pharmaceuticals, a division of Pfizer, will pay $491 million to settle criminal and civil charges of promoting its prescription transplant drug Rapamune for off-label, unapproved uses.
Doctors are allowed to prescribe drugs for off-label uses, but drug companies are not allowed to promote them for that.
Wyeth received FDA approval in 1999 to use Rapamune to help suppress rejection in kidney transplants, but it trained and encouraged its sales force to sell the drug to use in all transplants. Pfizer bought Wyeth in 2009.
Wyeth pleaded guilty to a criminal information of misbranding the drug. A federal judge in Oklahoma City accepted the plea, which includes a criminal fine of $157.6 million and forfeiture of $76 million.
Wyeth also made civil settlements with the federal government and the states, totaling $257.4 million. The federal government will get $230.1 million of the civil fines, and the state $27.3 million.
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