Pfizer Inc., the world’s largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription
drug promotions, the Justice Department announced today.
The department said the $2.3 billion settlement included
a $1.2 billion criminal fine, the largest criminal fine in U.S. history. The agreement also included a criminal forfeiture
of $105 million.
"Combating health care fraud is one of this administration’s top priorities," Associate
Attorney General Thomas Perelli said in announcing the settlement. He said it illustrates ways the department "can help
the American public at a time when budgets are tight and health care costs are rising."
The overall settlement
is the largest ever paid by a drug company for alleged violations of federal drug rules.
The government said the
company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different
than those the drugs had been approved for by federal regulators.
Use of drugs for so-called "off-label"
medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been
approved by the Food and Drug Administration.
A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired
in 2003, has entered an agreement to plead guilty to one count of felony misbranding.
"These agreements bring
final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing
and delivering innovative medicines to treat patients dealing with some of the world’s most debilitating diseases," said
Amy W. Schulman, senior vice president and general counsel of Pfizer.