Pfizer to Pay $491M to Settle Rapamune Off-Label Marketing Charges

Washington, DC: Pfizer will pay $491 million to settle criminal and civil charges relating to its off-label marketing of Rapamune. The US Justice Department had claimed the drug company marketed the kidney-transplant drug for patients who received non-kidney organ transplants.

The Justice Department began its investigation over four years ago, and Pfizer inherited the probe when it bought Wyeth in 2009.

According to the Justice Department, Wyeth trained sales reps to push Rapamune for unapproved uses and offered bonuses to persuade them to flog the drug for patients it wasn't cleared to treat. "This was a systemic, corporate effort to seek profit over safety," U.S. Attorney Sanford Coats said in a statement. "Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties."

Under the settlement agreement, Pfizer's Wyeth division pleaded guilty to a criminal misbranding violation under the Food, Drug and Cosmetics Act. The deal includes a criminal fine of $157.58 million and asset forfeiture amounting to $76 million, or $233.5 million total. Civil payments to the government and states add another $257.4 million, for a total of $490.9 million.

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Published on Jul-31-13