Wyeth Pharmaceuticals has pleaded guilty to misbranding a drug that prevents the rejection of organ transplants and agreed to pay US$490.9 million, the US Justice Department said on Tuesday.
The US$490.9 million will resolve Wyeth’s criminal and civil liability stemming from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the US Food and Drug Administration (FDA).
In 1999, Wyeth received approval from the FDA for Rapamune use in renal — kidney — transplant patients. The immunosuppressive drug prevents the body’s immune system from rejecting a transplanted organ.
Wyeth was accused of training its Rapamune sales force in the US to promote the use of the drug in non-renal organ transplants and encouraged them to offer financial incentives to target all types of transplant patients to boost sales.
The FDA had not authorized the so-called “off-label” uses.
“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,” Sanford Coats, US attorney for the Western District of Oklahoma, said in a statement.
Wyeth pleaded guilty to a criminal a misbranding violation and has agreed to pay a criminal fine and forfeiture totaling US$233.5 million, the US Department of Justice said.
The company, under a plea agreement that has been accepted by the US District Court in Oklahoma City, also has agreed to pay a criminal fine of US$157.58 million and forfeit assets of US$76 million.
The US government alleged that Wyeth also violated the False Claims Act from 1998 through 2009 by promoting Papamune for unapproved purposes that resulted in false claims to government healthcare programs.
US pharmaceutical giant Pfizer Inc, which acquired Wyeth in October 2009, highlighted that the agreement was between Wyeth and the Justice Department, all 50 states and the District of Columbia.
“Pfizer was not a subject or target of this matter and cooperated fully with the government from the time it learned of this investigation in October 2009,” the company said in an e-mail to reporters.
Pfizer in December last year agreed to pay US$55 million to settle US government allegations that Wyeth promoted an acid reflux drug, Protonix, for unapproved uses between February 2000 and June 2001.
Pfizer denied the allegations in that civil complaint.