What was the Bextra scandal and why was the fine so large?
A $2.3 billion settlement — then the largest healthcare fraud fine in US history — over the illegal promotion of an anti-inflammatory painkiller the FDA had already declined to approve for those uses.
Bextra was an anti-inflammatory painkiller. According to NPR's reporting on the settlement, Pfizer asked the FDA to approve Bextra for additional uses, the agency declined over safety concerns, and Pfizer promoted it for those unapproved uses anyway. The drug was voluntarily withdrawn in 2005.
In September 2009 Pfizer finalised a $2.3 billion resolution with the Justice Department: $1.3 billion as a criminal penalty tied only to Bextra, and $1.0 billion in civil payments covering several medicines. A subsidiary, Pharmacia & Upjohn, pleaded guilty to one criminal count under the Food, Drug, and Cosmetic Act. The criminal component was described at the time as the largest criminal fine ever imposed by the US government, and the investigation had been triggered by whistleblower lawsuits filed in three states.