BOSTON – A pharmaceutical company has agreed to pay $35 million in a 41-state settlement involving the unlawful promotion of the drug Rapamune for uses not approved by the U.S. Food and Drug Administration, Attorney General Martha Coakley announced last week.
Coakley’s office joined the settlement with Wyeth Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer Inc., to resolve claims that the company violated state consumer protection laws by misrepresenting the uses and benefits of Rapamune, a drug currently approved by the FDA to prevent organ rejection after kidney transplant surgery.
Under the terms of the settlement, Pfizer will pay more than $726,000 to the commonwealth, including $100,000 in attorney’s fees and costs.
According to the complaint, despite Rapamune’s limited approval for use in kidney transplants only, and despite black-box warnings required by the FDA relating to use in lung and liver transplants, Wyeth allegedly promoted Rapamune for off-label uses such as with liver, heart, pancreas, and lung-transplant patients. •