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.
“This was a systematic, corporate effort to seek profit over safety,” Coats said.
By promoting the drug for treatment of other kinds of transplant patients, Wyeth, a subsidiary of pharmaceutical giant Pfizer, caused false or fraudulent Medicaid claims to be submitted, according to allegations contained in lawsuits brought against Wyeth by former employees, the federal government and participating states.
The lawsuits were filed in federal courts in Oklahoma and Pennsylvania. The civil settlement resolves two lawsuits pending in Oklahoma City federal court, authorities said.
Pfizer, which acquired Wyeth in 2009, was not the subject of the U.S. Justice Department investigation because Wyeth's criminal conduct ended in 2006, Coats said.
“Pfizer was not a subject or a target of this matter and cooperated fully with the government from the time we learned of this investigation in October 2009,” Christopher Loder, a Pfizer spokesman, said Tuesday. “Pfizer and its subsidiaries have practices and procedures that are designed to ensure its promotion and compliance meet or exceed the requirements of law.”