American drug maker Pfizer Inc. and its subsidiary, Pharmacia & Upjohn Company Inc., have consented to pay a record-breaking amount to settle criminal and civil charges against the two companies for illegally marketing Bextra, an anti-inflammatory medication that Pfizer pulled from the shelves in 2005 because of its health risks.  The settlement also resolves allegations that the companies violated the False Claims Act in marketing Bextra and three other drugs.  

Pharmacia & Upjohn Company will plead guilty to a felony charge for violating the Food, Drug and Cosmetic Act.  To obtain approval for a drug under the Act, a company must file an application with the FDA in which the intended uses of the medication are disclosed.  It is illegal for a pharmaceutical company to promote or market its products for an “off-label” use – any use that has not been specifically identified in the drug application and approved by the FDA.  But Pfizer actively promoted Bextra for numerous uses that the FDA refused to approve precisely because of known safety concerns.  To resolve the criminal charges against them arising from this misconduct, Pfizer will pay the largest criminal fine on record for any matter in U.S. history.  Pharmacia & Upjohn will also forfeit a substantial amount as part of the settlement.   

Pfizer has also settled civil allegations that it violated the False Claims Act by illegally promoting Bextra and three other drugs – Zyvox, an antibiotic; Geodon, an anti-psychotic drug; and Lyrica, an anti-epileptic drug.  The United States alleged that the company submitted claims to government health care programs for sales of the drugs to treat conditions for which the medications had not been approved, and thus were not eligible for payment under the government programs. In addition, the government alleged that Pfizer paid illegal kickbacks to health care providers to entice them to prescribe the drugs for off-label uses.  Pfizer will pay a staggering sum to resolve these allegations, the largest civil fraud settlement ever paid by a pharmaceutical company.

Pfizer’s conduct was first disclosed in whistleblower lawsuits filed under the False Claims Act in federal courts in Massachusetts, Pennsylvania and Kentucky.  The Qui Tam provisions of the Act authorize payment to whistleblowers in the event of any recovery by the government.  The six whistleblowers in the Pfizer suits will receive a handsome share of the civil recovery.

For the full story, go to Department of Justice’s Press Release.