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Wyeth Pharmaceuticals to Pay $491 Million to Resolve Allegations of Off-Label Marketing of Rapamune

Rhode Island to receive $201,502 for federal/state Medicaid share

Attorney General Peter F. Kilmartin announced today that Rhode Island has joined with other states and the federal government to announce a $491 million dollar settlement to resolve civil and criminal allegations that Wyeth Pharmaceuticals, Inc. (Wyeth) promoted the sale and use of Rapamune for uses for which it had not been approved by the FDA. Rapamune is an FDA-approved kidney transplant drug which is prescribed to prevent the body from rejecting a donor organ that has been transplanted into the body. Under the terms of the settlement, Rhode Island's state/federal Medicaid share will be $201,502.

The investigation resulted from actions filed in the United States District Courts for the Eastern District of Pennsylvania and the Western District of Oklahoma under the federal False Claims Act and various state false claims statutes. The complaints alleged that Wyeth knowingly promoted the sale and use of Rapamune for use in connection with solid organ transplant patients other than kidney transplant patients and 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.

"The establishment and enforcement of federal rules and regulations for the marketing and use of drugs is to protect the health and safety of patients, yet pharmaceutical companies continue to bypass federal controls to protect their profits," said Attorney General Kilmartin.

Wyeth has agreed to pay the states and the federal government $257,400,000.00 in civil damages and penalties to resolve the civil allegations of off label marketing of Rapamune. Additionally, Wyeth has pled guilty in federal court in Oklahoma to violations of the U.S. Food, Drug, and Cosmetic Act, and has agreed to pay $233,600,000.00 in criminal fines and forfeitures.

In late 2009 Pfizer Inc. acquired Wyeth. The off-label marketing, and the conduct to which Wyeth pled guilty, occurred prior to Pfizer's acquisition of Wyeth. Pfizer cooperated fully with the federal government and the states in the investigation.

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