Pfizer will pay $491 million to settle criminal and civil charges related to unlawful marketing and promotion by Wyeth Pharmaceuticals of the drug Rapamune. Pfizer acquired the drug when it purchased Wyeth in 2009.

The settlement resolves two lawsuits filed by former Wyeth employees under the whistleblower provisions of the False Claims Act. Their suits alleged that Wyeth trained its national Rapamune sales force to promote the use of the immunosuppressant in patients receiving transplants of organs other than kidneys.

Wyeth admitted to off-label marketing practices for liver, heart, pancreas and other non-kidney transplant use; converting or switching patients to Rapamune; using it with unapproved combinations of other immunosuppressive drugs; encouraging its sales force to approach physicians about initiating investigator originated protocols to study off-label uses; approving business plans and monthly reports that included plans for off-label marketing; inviting physicians to engage in off-label research; and providing off-label continuing medical education opportunities.

The promotions by Wyeth represented “a systemic, corporate effort to seek profit over safety,” says Sanford Coats, U.S. Attorney for the Western District of Oklahoma where the cases were filed. It led to unapproved uses of the drug and false insurance claims submitted to and paid by federal healthcare programs.

Rapamune prevents the immune system from attacking and rejecting a transplanted kidney. In 1999 the FDA approved the drug for kidney transplants and in 2003 approval was extended to include first-line therapy for low to moderate immunologic risk patients in combination with other drugs. It is not approved for use in connection with any other transplanted organs.