Pfizer Unit To Settle Unlawful Medication-Marketing Suit For $491 Million

Although none of the major television networks covered the story, many major online and print media sources on Tuesday covered a settlement agreement by Pfizer’s Wyeth unit related to illegal marketing of a kidney-transplant treatment. Nearly all of the articles included quotes from Federal officials, all of whom emphasized that the company’s off-label promotions placed patient safety in jeopardy. In their ending paragraphs, most of the stories noted that Pfizer also released its second-quarter earnings report yesterday.

The AP (7/31, Johnson, Seaman) reports that the US Department of Justice on Tuesday announced 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), the DOJ “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.”

Bloomberg News (7/31, Feeley) adds that Coats’ spokesperson Bob Troester said Judge Miles-LaGrange sentenced the drug maker to “pay the fine and forfeit assets as laid out in the plea agreement” on Tuesday, after “Wyeth officials entered a guilty plea” to the “charge of misbranding a drug under the Food, Drug and Cosmetic Act.”

Meanwhile, several publications, including the Philadelphia Inquirer (7/31, Sell), added that also on Tuesday, Pfizer announced its second-quarter earnings, reporting a revenue decline of “7 percent, to $13 billion” from Q1 and a revenue decrease of “$995 million or 7% from the same period in 2012.”

 Also covering the story are the Financial Times (7/31, Subscription Publication), AFP (7/31), BBC News (7/31, Jack), the Bergen (NJ) Record (7/31), the Oklahoman (7/31, Willert) and the Philadelphia Business Journal (7/31, George, Subscription Publication) “Health Care Inc” blog.