Wyeth is facing $490.9 million in fines for marketing drugs illegally. The company pled guilty to misbranding a medication that prevents organ transplant rejection. The US Justice Department has said on Tuesday that the company has agreed to pay the full amount of the fines. The whopping settlement will resolve any civil and criminal liabilities that have stemmed from unlawfully marketing the prescription medication called Rapamune for uses that were not approved by the US FDA as effective and safe.
The FDA approved Rapamune for use in kidney transplant cases to prevent rejection of the organ. The drug is immunosuppressive that prevents the immune system from rejecting organs after a transplant. The company was accused of teaching its sales staff in the US to promote using the drug in transplants that were not kidneys, and encouraged the offering of financial boosts as a way of targeting any type of transplant sales.
Off label uses have not been authorized by the FDA.
According to US attorney with the Western District of Oklahoma, Sanford Coats, the off use sales of the drug were a corporate attempt to seek profits above ensuring safety. Companies who choose to ignore compliance with regulations set by the FDA face stiff penalties, as well as criminal prosecution.
Wyeth entered a guilty plea of criminal a misbranding violation, and has agreed that it will pay criminal fines and forfeiture for a total of $233.5 million. Under a plea agreement accepted by the US District Court in Oklahoma City, the company has agreed that it will pay criminal fines of $157.58 million, as well as forfeiture of $76 million.
According to the government, Wyeth also was in violation of the False Claims Act between 1998 and 2009, because of the promotion of Rapamune for off label uses that were not approved by the FDA. These uses resulted in false claims to health care programs run by the government.
Pfizer, the US pharmaceutical giant, acquired Wyeth in October of 2009 and stressed that the agreement was between Wyeth and the DOJ, as well as all of the 50 states and the District of Columbia. Pfizer has asserted that the company was not a target or subject of the matter, and has worked to cooperate fully with the government from the time it was informed of the investigation in October of 2009. In December of 2012, Pfizer agreed to a settlement of $55 million to settle allegations from the US government that Wyeth was promoting the acid-reflux medications for uses that had not been approved by the FDA between February of 2000 and June of 2001.