On July 31, 2013, the United States Department of Justice announced that Wyeth Pharmaceuticals pleaded guilty to misbranding a drug and agreed to pay $490.9 million to resolve criminal and civil liability. The drug in question, Rapamune, was approved by the FDA in 1999 for use in preventing the body’s immune system from rejecting kidney transplants. Wyeth, however, allegedly trained its U.S. sales force to promote the drug for use in transplants of other organs, something that is referred to as “off-label” use.
FDA approval is based on lengthy clinical trials, according to a U.S. official, and “Compliance with these approved uses is important to protect patient safety.” This same official said that, “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.”
Wyeth was acquired by Pfizer, Inc. in October of 2009. Pfizer itself was not a target of the investigation. In December 2012 Pfizer also agreed to pay $55 million to the U.S. government to settle allegations that Wyeth promoted an acid-reflux drug, Protonix, for off-label uses.