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US: Pfizer to pay record $2.3B penalty over promotions

By Devlin Barrett
Thu Sep 3 03:19:20 EST 2009
Wed Sep 2 17:19:20 UTC 2009

WASHINGTON, Sept 2 AP - Pfizer Inc, the world's largest drug maker, will pay a record $US2.3 billion ($A2.78 billion) civil and criminal penalty over unlawful prescription drug promotions, the Justice Department announced on Wednesday.

The department said the $US2.3 billion ($A2.78 billion) settlement included a $US1.2 billion ($A1.45 billion) criminal fine, the largest criminal fine in US history. The agreement also included a criminal forfeiture of $US105 million ($A127.06 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.