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Pfizer agrees to pay $491 million in drug suit

The company’s Pfizer unit marketed a kidney transplant drug for unapproved uses

Pfizer’s pocketbook is nearly $500 million lighter today. The pharmaceutical giant announced that its subsidiary, Wyeth, is pleading guilty to federal charges and will pay $491 million for marketing one of its drugs for uses not approved by the Food and Drug Administration (FDA).

Wyeth pleaded guilty to one count of misbranding Rapamune, a kidney transplant drug, for unapproved uses, including other transplant procedures, the Justice Department said in a statement today. Wyeth will pay a $157.5 million criminal fine, will forfeit assets worth $76 million and will pay another $257 million to resolve civil claims that it trained its staff to market Rapamune for heart, lung, liver and pancreas transplants.

“FDA’s drug approval process ensures companies market their products for uses proven safe and effective,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.  “We will hold accountable those who put patients’ health at risk in pursuit of financial gain.”

Rapamune has been approved since 1999, but only for kidney transplant patients.

Read more about this story on Bloomberg.

For more recent InsideCounsel stories about the pharmaceutical industry, see:

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Contributing Author

Cathleen Flahardy

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