Pfizer settled an investigation Wednesday by the U.S. Department of Justice (DoJ) with a $2.3 billion payment, regarding past off-label promotional practices related to several drugs, including the steroidal anti-inflammatory pain medication Bextra, which Pfizer withdrew from the market in 2005, due to reports that it caused heart attacks and strokes.
The New York City-based company said this “final agreement” resolves DoJ investigations involving alleged past off-label promotional practices concerning Bextra, Zyvox, Geodon and Lyrica, allegations related to certain payments to healthcare professionals involving these and nine other Pfizer medicines, and several related qui tam actions.
Pfizer previously disclosed a related $2.3 billion charge to its 2008 fourth quarter and full-year 2008 earnings in connection with the DoJ agreement in principle on Jan. 26. The company said no additional charge to its earnings will be recorded in connection with this settlement.
“We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect,” said Amy W. Schulman, senior vice president and general counsel of Pfizer.
As part of the DoJ settlement, Pfizer has entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). The agreement institutes certain new measures and requires Pfizer to continue maintenance of a corporate compliance program for a period of five years.