July 30th, 2013
Wyeth Fined $490.9 Million for Unlawful Marketing of Rapamune
By Melanie Sena
Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA, the Justice Department announced in a statement.
The Federal Food, Drug and Cosmetic Act (FDCA) requires a company to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or off-label uses until the company receives FDA approval for the new intended uses.
In 1999, Wyeth received approval from the FDA for Rapamune, an immunosuppressive drug that prevents the body’s immune system from rejecting a transplanted organ, for use in renal transplant patients. However, the information alleges, Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients, the Justice Department reports.