Pfizer Inc. has agreed to pay almost $491 million to settle allegations it illegally marketed an organ transplant drug and will return more than $27 million to state health care programs, including about $700,000 to Oklahoma, a prosecutor said Tuesday.
U.S. Attorney Sanford Coats said the settlement agreement with Pfizer includes civil settlements with the federal government and the states totaling $257 million. About $230 million will go to the federal government and the rest will go to state Medicaid programs.
In addition to the civil claims, Pfizer has agreed to pay a criminal fine of about $158 million and forfeit assets of $76 million.
The government alleged that Wyeth Pharmaceuticals, which was bought by Pfizer in 2009, promoted the drug Rapamune for unapproved uses. Some of those uses were not medically accepted and were not covered by Medicaid, Medicare and other federal health care programs.
In 1999 Wyeth received approval from the Food and Drug Administration for Rapamune to be used by kidney transplant patients. But prosecutors alleged that Wyeth trained its Rapamune sales force to promote use of the drug in patients who received transplants of other organs. Wyeth provided the sales force with materials regarding its use and trained them on how to use the materials in presentations to transplant physicians.
“Actions like these are called misbranding,” said Coats, who is U.S. attorney for the Western District of Oklahoma. “This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.”
Coats said the investigation did not produce any evidence that the unapproved use of the prescription drug caused any deaths among transplant patients.
