Pfizer agrees to $491M settlement in off-label marketing case

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Pfizer has agreed to pay a $491m settlement fee in criminal and civil penalties following allegations of off-label marketing by Wyeth, a company that it acquired in 2009.

The case revolves around the drug Rapamune, which could be prescribed to prevent rejection of transplanted kidneys. According to The US Department of Justice, "Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales."

"This was a systemic, corporate effort to seek profit over safety... Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties."

U.S. Attorney Sanford Coats, in a statement.

Pfizer has stressed that this off-label marketing occurred before it acquired Wyeth.