To resolve criminal and civil claims over the illegal marketing of the recalled painkiller Bextra and other drugs, Pfizer has agreed to pay $2.3 billion. It is the fourth Pfizer settlement relating to illegal marketing of their products since 2002, and includes the largest criminal fine in U.S. history.
The deal between the pharmaceutical company and the U.S. Justice Department includes a $1.195 billion criminal fine to resolve claims that they promoted drugs for uses that were not approved by the FDA or established as safe and effective. The drug maker will also pay another $1 billion in civil penalties and make a five-year corporate integrity agreement with the U.S. Department of Health and Human Services.
The Pfizer settlement concludes a four-year investigation into the practices of the world’s largest drug company. The investigation was brought about after whistleblowers from several states filed lawsuits that alleged Pfizer was defrauding government health programs due to its illegal marketing practices. Under the terms of the deal, six whistleblowers will share in more than $100 million of the settlement.
Bextra (valdecoxib) was approved by FDA in 1991 for the treatment of arthritis and menstrual cramps. However, Pfizer marketed the drug to doctors for the treatment of acute pain, which was an “off-label” use. While doctors can prescribe drugs for non-approved uses, it is illegal for drug companies to market them that way. A Bextra recall was issued in April 2005 after it was found that it increased the risk of heart attack, stroke and a serious, potentially fatal skin reaction known as Stevens-Johnson syndrome.
Government prosecutors say that Pfizer marketed Bextra for uses that would require larger doses even after learning that the health risks of the drug increased with dosage. Prosecutors said that Pfizer also provided doctors with kickbacks and incentives including paying doctors for weekend meetings in resort locations. The government also accused Pfizer of illegally marketing the epilepsy drug Neurontin, the antipsychotic Geodon, and several other drugs.
The felony plea will be made by Pfizer subsidiary Pharmacia & Upjohn over its marketing of Bextra specifically. Pfizer has not admitted guilt in any of the civil charges brought against it by whistleblowers, although it is settling with them.
The “corporate integrity” settlement Pfizer is signing is a pledge of good behavior with the government, agreeing to reform its marketing practices. It is the third such pledge Pfizer has made in less than ten years. It signed an agreement in 2002 over its marketing of Lipitor, and again in 2004 over marketing practices for Neurontin.