Wyeth settles whistle-blower charges of off-label marketing for $490.9MReprints
Wyeth Pharmaceuticals Inc. has agreed to pay $490.9 million to settle whistle-blower charges that it illegally marketed Rapamune, a drug intended for kidney transplant patients, for unapproved uses, the U.S. Justice Department said Tuesday.
The settlement by Wyeth, which was acquired by New York-based Pfizer Inc. in 2009, will settle criminal and civil liability arising from its unlawful marketing of the drug, the Justice Department said in a statement.
Although Wyeth received approval from the U.S. Food and Drug Administration in 1999 for Rapamune's use in renal transplant patients, it trained its national sales force to promote its use in nonrenal transplant patents in an effort to boost the drug's sales, the DOJ said in the statement.
“The FDA approves drugs for certain uses after lengthy clinical trials,” said Sanford Coats, U.S. Attorney for the Western District of Oklahoma, in the statement. “Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses.”
The DOJ, which had charged Wyeth with violating the False Claims Act from 1998 to 2009 by promoting the drug for off-label uses, said the settlement includes a criminal fine of $157.6 million and the forfeiture of $76 million in assets, as well as civil settlements with the federal government and states totaling $257.4 million.
The DOJ said the settlement resolves two whistle-blower lawsuits filed under the False Claims Act by two former Rapamune sales representatives. Their share of the civil settlement has not been resolved, the department said in the statement.
Pfizer said in a statement it “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. That cooperation was acknowledged today by the Justice Department.
“Under the final agreement, Wyeth will make a total monetary payment of $491 million and plead guilty to a misdemeanor misbranding offense under the U.S Federal Food, Drug, and Cosmetic Act relating to conduct that ended in July 2006. The monetary payment was recorded as a charge in Pfizer's third quarter 2012 earnings report and covers the DOJ investigation and two (whistle-blower) actions."
The statement continued, “Pfizer and its subsidiaries have practices and procedures that are designed to ensure its promotion and compliance meet or exceed the requirements of law."