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Attorney General's News Release

July 31, 2013

Attorney General Koster announces $1.5M for Missouriís Medicaid program from national settlement with Wyeth Pharmaceuticals --Drug maker settles litigation over off-label marketing of Rapamune--

Jefferson City, Mo. – Attorney General Chris Koster today announced that Missouri will receive $1.5 million for its share of a national settlement with Wyeth Pharmaceuticals, Inc..  The settlement resolves federal civil and criminal litigation against the company, alleging that it promoted the sale and use of Rapamune for unapproved or off-label purposes. Rapamune is an FDA approved kidney transplant drug prescribed to prevent the body from rejecting a donor organ that has been transplanted into the body.  

State and federal Medicaid fraud investigators began looking at Wyeth following the filing of federal complaints by three whistleblowers alleging the company was violating the False Claims Act and various state false claims statutes. The complaints alleged that Wyeth knowingly promoted the sale and use of Rapamune in connection with solid organ transplant patients other than kidney transplant patients, and in other unauthorized treatment regimens. A team of officials from several state Medicaid Fraud Control units partnered with the U.S. Department of Justice and the U.S. Attorney in Oklahoma to negotiate a settlement of the litigation.

Under the terms of the settlement, Wyeth agreed to pay the states and the federal government over $257 million dollars in civil damages and penalties to resolve the civil allegations of off-label marketing of Rapamune.  Over $60 million dollars of this amount will go to the Medicaid program, which is funded jointly by the states and the federal government.  The total portion of the settlement amount recovered for Medicaid in Missouri is $1,513,807.70.

"This settlement agreement returns scarce health-care dollars to the state of Missouri," said Koster. "It is my hope that this case serves as a reminder to pharmaceutical companies to promote their products only for FDA-approved clinical use."

Pfizer Inc acquired Wyeth in late 2009, after the off-label marketing was alleged to have occurred.  Pfizer cooperated fully with the federal government and the states in the investigation.

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