A Pennsylvania-based pharmaceutical company agreed Tuesday to pay $490.9 million, including $700,000 to Oklahoma, for unlawfully marketing the kidney transplant drug Rapamune, authorities said.
Wyeth Pharmaceuticals Inc., pleaded guilty in Oklahoma City federal court to a misdemeanor violation under the Federal Food, Drug and Cosmetic Act, and agreed to pay $233.5 million in criminal fines and forfeitures.
Additionally, the resolution includes civil settlements with the federal government and each of the 50 states totaling $257.4 million, about $700,000 of which will go to “repay loses” to Oklahoma's Medicaid program, Oklahoma City-based U.S. Attorney Sanford C. Coats announced at a midday news conference Tuesday.
“The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses,” Coats said. “Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales.”
Rapamune, which is an “immunosuppressive” drug that prevents the body's immune system from rejecting a transplanted organ, is only approved by the Food and Drug Administration for use in treating kidney transplant patients.
Prosecutors alleged Wyeth marketed Rapamune for use in patients who had received liver, heart and other “non-renal” transplants.