Pfizer Inc., will pay $409.9 million for illegally marketing the kidney transplant drug Rapamune, according to the U.S. Justice Department. Pfizer, which acquired Wyeth Pharmaceuticals in 2009, trained its sales force to promote the drug for unapproved uses in order to boost sales with little regard for the health and safety of “a highly vulnerable patient population dependent on life-sustaining therapy,” says Antionette Henry, Food and Drug Administration (FDA) Agent in Charge.
Rapamune was approved by the FDA in 1999 for kidney transplant patients to help keep the immune system from rejecting the new organ. Wyeth pushed its sales team to promote the drug’s use for other organ transplants for which the drug had not been tested or approved, including liver, lung, and heart transplants. The practice continued until 2006. Pfizer didn’t learn about the illegal marketing practices until October 2009, when the drug company acquired Wyeth.
Doctors have the discretion to prescribe drugs for indications for which they are not FDA-approved. However, drug companies are forbidden to promote these “off-label” uses to doctors or patients.
According to the settlement, Pfizer will pay $257.4 million in civil settlements with federal and state governments and a $157.6 million criminal fine. The drug company will also forfeit $76 million in assets.