Pfizer Settles in Fraudulent Marketing Case9 Sep, 2009 Response This Week
NEW YORK – Pharmaceutical manufacturer Pfizer Inc. finalized an agreement with the U.S. Department of Justice (DOJ) to settle an investigation on past promotional practices for the drug Bextra – a product voluntarily withdrawn from the market in 2005. The settlement, worth $2.3 billion, also resolves investigations into off-label promotional practices of Pfizer’s Zyvox, Geodon, Lyrica and nine other medicines.
The government accused Pfizer of marketing Bextra off label for several uses and dosages that the U.S. Food and Drug Administration (FDA) had declined for safety reasons. The allegations said that from 2002 through April 2005, Pfizer used misleading claims of safety to promote Bextra for unapproved uses and for doses above the approved level.
Pharmacia & Upjohn, the unit of Pfizer which manufactured Bextra, agreed to plea guilty to one criminal count of violating the U.S. Food, Drug and Cosmetic Act for misbranding the pain reliever.
Other payments in the recent settlement include $33 million to 42 states for civil consumer protection allegations related to promotional practices of Geodon. In addition, the company will make payments of $503 million to resolve civil allegations concerning past promotional practices related to Bextra, $98 million for Zyvox, and $50 million for Lyrica.
“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 from a leading worldwide company dedicated to healing and better health,” says Amy W. Schulman, senior vice president and general counsel of Pfizer. “Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company.”