Qui Tam

Justice Department Intervenes in FCA Action Against Pfizer

By Nolan and Auerbach

Earlier this week, the federal government and nineteen state governments intervened in a False Claims Act qui tam action against Pfizer and its subsidiary Wyeth Pharmaceuticals, accusing the companies of illegally off-label marketing their drug Rapamune, a drug used to prevent rejection of kidney transplants.

While health care providers can prescribe drugs for anything they see fit, it is illegal for drug companies to promote their drugs for uses not approved by the FDA. In this case, the whistleblowers, former Wyeth sales reps, maintained that they were encouraged to promote this drug for heart, lung, liver and pancreas transplants, even though the FDA had only approved the drug for kidney transplants.

Notably, the federal and state governments initially declined to intervene in this qui tam action. However, because the whistleblowers were able to move the case forward and piece together additional evidence of wrongdoing, the governments decided to take a second look.

Pfizer could be in violation of a corporate integrity agreement it signed a year ago, when it settled another FCA action for $2.3 billion, quieting similar claims of off-label promotions.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

Full post as published by Pharma 101 - Pharmaceutical Fraud on September 24, 2010 (boomark / email).