Wyeth pays US$490m to resolve liabilities over immunosuppressive drug
US Justice Department claims that Wyeth marketed Rapamune for unapproved uses
Pfizer-owned Wyeth Pharmaceuticals has agreed to pay US$490.9m to resolve criminal and civil liability claims from its unlawful marketing of the prescription immunosuppressant drug Rapamune, says the US Justice Department.
The Justice Department claims that Wyeth marketed the drug in America for uses beyond those approved by the US Food and Drug Administration (FDA). Rapamune was approved to prevent kidney transplant patients from rejecting their new organs.
The Justice Department cited claims that Wyeth trained its national Rapamune sales staff to promote treating transplant patients who had received different organs.
'Wyeth encouraged sales force members, through financial incentives, to target all transplant patient populations to increase Rapamune sales,' the Justice Department said.
'The FDA’s drug approval process ensures companies market their products for uses proven safe and effective,' said Stuart Delery, Acting Assistant Attorney General at the Justice Department's Civil Division. 'We will hold accountable those who put patients’ health at risk in pursuit of financial gain.'
The Federal Food, Drug, and Cosmetic Act (FDCA) requires pharma companies to specify the intended uses of medicines when seeking FDA market approvals. Drugs cannot be sold US-wide for unapproved or off-label uses.
In this out-of-court settlement, Wyeth pleaded guilty to a criminal misbranding violation, without admitting the now settled civil claims.