Pa. shares in $491 million multi-state Wyeth settlement in Rapamune off-label marketing case

Pennsylvania has joined in a $491 million multi-state settlement that

resolves both civil and criminal allegations that Wyeth Pharmaceuticals engaged in off-label marketing for its kidney transplant rejection drug Rapamune.

Wyeth, which is a Delaware corporation headquartered in Montgomery County, Pa., promoted the sale and use of the medication for uses not approved by the federal Food and Drug Administration, according to the Pennsylvania Attorney General’s Office, which announced the hefty settlement figure on July 30.

As per the settlement terms, the drug manufacturer has agreed to pay a handful of states and the federal government more than $257 million civil damages and penalties to resolve the civil allegations of off-label marketing, more than $60 million of which will go toward Medicaid programs, which are jointly funded by the states and the federal government, and administered by individual states.

Pennsylvania will receive more than $1.4 million for its share in the settlement, according to the office of Attorney General Kathleen Kane.

Wyeth also pleaded guilty in federal court in Oklahoma to violations of the U.S. Food, Drug and Cosmetic Act, and has agreed to pay more than $233 million in criminal fines and forfeitures, the Attorney General’s Office announced.

The complaint against Wyeth alleged that the company knowingly promoted the sale and use of Rapamune with solid organ transplant patients other than kidney transplant recipients, and that the drugmaker promoted the drug to be used in treatment regimens with transplant patients who had used other immunosuppressant drugs before turning to Rapamune and who never received Rapamune at the time of their kidney transplant.

Rapamune is a pharmaceutical that is often prescribed to help transplant recipients stave off organ rejection.

Investigators looked into the matter following the filing of various qui tam civil actions at the federal District Courts in Philadelphia and western Oklahoma, according to Kane’s office.

The drug company Pfizer, who acquired Wyeth Pharmaceuticals back in 2009, fully cooperated with the federal government and the states of Pennsylvania, Massachusetts, Virginia, Florida, Michigan and South Carolina, in the widespread investigation, the Pennsylvania Attorney General’s Office stated.

The conduct that gave rise to the off-label marketing allegations took place before Pfizer’s acquisition of Wyeth.