The AP (7/31, Johnson, Seaman) reports that the Justice Department on Tuesday announced that Pfizer’s Wyeth division agreed to $490.9 million to settle civil and Federal lawsuits related to illegal, off-label marketing of its prescription medication, Rapamune (sirolimus).
CQ (7/31, Reichard, Subscription Publication) adds that DOJ officials said the Food and Drug Administration approved the immunosuppressive therapy for “kidney transplant patients but that Wyeth also marketed it on an unapproved basis for other types of organ transplant patients,” which resulted in false Medicare and Medicaid claims. The investigation was spurred by “whistleblower suits filed in 2005 and 2007 and involved conduct” that occurred prior to Pfizer’s purchase of Wyeth in 2009.
According to the New York Times (7/31, B8, Thomas, Subscription Publication, 1.68M), the department “opted to join the lawsuit” in 2010, after a whistle-blower lawsuit filed by two former Wyeth Pharmaceuticals employees was made public and “lawmakers announced a Congressional inquiry.” The settlement announced yesterday, which “also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia.”
Reuters (7/31, Ingram) notes that Pfizer disclosed the settlement preliminarily, in November 2012 filing with the Securities and Exchange Commission; and US District Judge Vicki Miles-LaGrange in Oklahoma City accepted the plea agreement on Tuesday. Sanford Coats, the US Attorney for the Western District of Oklahoma emphasized the importance of complying the treatment uses approved by the FDA to ensure patient safety. In addition, Reuters quotes FDA Special Agent in Charge Antoinette Henry as saying, “Wyeth’s conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy.”
