TRENTON – New Jersey will receive approximately $700,000 as a result of its participation in a national settlement resolving allegations that Wyeth Pharmaceuticals, Inc., violated state and federal laws by marketing one of its drugs for uses not approved by the federal Food and Drug Administration (FDA), Acting Attorney General John J. Hoffman announced today.
According to Hoffman, the settlement resolves allegations that Wyeth violated the federal False Claims Act, as well as False Claims Act statutes in New Jersey and other states, by unlawfully promoting its kidney transplant drug Rapamune for use in other kinds of organ transplant patients.
Rapamune is only approved by the FDA for use in treating kidney transplant patients. Promotion of the drug for treatment of other kinds of transplant patients 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 the participating states.
“Marketing drugs for unapproved uses is wholly inappropriate, and the resultant false billing to government health care programs costs every one of us,” Hoffman said. “Through our own efforts, and through a collaborative effort with our state and federal partners, we are committed to identifying Medicaid fraud and abuse, and to holding those who engage in such conduct accountable.”
Hoffman explained that an investigation of Wyeth’s marketing of Rapamune resulted from qui tam actions filed by former company employees under the federal False Claims Act, as well as various state false claims statutes. The lawsuits were filed in federal courts in Oklahoma and Pennsylvania.
The complaints alleged that Wyeth knowingly promoted the sale and use of Rapamune (1) for use in connection with solid organ transplant patients other than kidney transplant patients and (2) in treatment regimens with transplant patients who used another immunosuppressant drug before using Rapamune, and who did not receive Rapamune at or around the time of a kidney transplant.
As part of the national settlement, Wyeth pleaded guilty today in federal court in Oklahoma to a misbranding offense under the federal Food, Drug and Cosmetic Act. As part of that agreement Wyeth, which is based in Collegeville, Pa., must pay more than $233 million in criminal fines and forfeitures.
According to the lawsuits against Wyeth, Rapamune is only approved for use in suppressing patient immune systems following a kidney transplant operation. The drug is applied, along with a second immunosuppressive drug called cyclosporine, and with corticosteroids, to prevent the body from rejecting the new kidney. The lawsuits alleged that Wyeth directed its workers to employ a number of marketing strategies designed to encourage the sale and use of Rapamune for other, unapproved purposes.
Wyeth was acquired in late 2009 by Pfizer, Inc. However, the alleged off-label marketing of Rapamune that was the focus of the multi-state investigation took place prior to Pfizer’s acquisition of Wyeth. Pfizer cooperated fully with the federal government and the states in the Rapamune investigation.
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