Pfizer has agreed to pay a fine of $490.9m to settle an investigation related to off-label marketing of immunosuppressive drug Rapamune, according to the US Department of Justice.
The drug was produced by Wyeth Pharmaceuticals, a company acquired by Pfizer in 2009.
According to Pfizer, Rapamune (sirolimus) is indicated for the prevention of organ rejection in kidney transplant patients aged 13 years or older.
The company, in a statement, said, “Pfizer was not a subject or target of this matter, and cooperated fully with the government from the time it learned of this investigation in October 2009.”
Wyeth received FDA approval for Rapamune in 1999 for use in renal (kidney) transplant patients. Once approved, a drug may not be used for unapproved (off-label) purposes until the clearance from FDA for the new intended uses, which are supposed to be specified under the Federal Food, Drug and Cosmetic Act (FDCA).
Wyeth has pleaded guilty of violating FDCA. In addition, Wyeth is also alleged to have violated the False Claims Act, from 1998 through 2009, by marketing Rapamune for unapproved uses.
The department, in a statement, said: “Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales.”
Sanford Coats, US attorney for the Western District of Oklahoma, said: “The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses.
“Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. 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.”
Under a plea agreement, which has been accepted by the U.S. District Court in Oklahoma City, Wyeth has agreed to pay a criminal fine of $157.58m and forfeit assets of $76m. The resolution also includes civil settlements with the federal government and the states totaling $257.4m.
Wyeth will pay $230.11m to the federal government and $27.28m to the states, to resolve the civil claims.