A Congressional committee is investigating allegations that a unit of Pfizer Inc. illegally promoted the kidney transplant drug Rapamune for treatments not approved by the Food and Drug Administration.
Committee members are also scrutinizing whether Wyeth Pharmaceuticals, Inc., targeted African-Americans in its promotional campaigns.
The House Committee on Oversight and Government Reform is investigating whether Wyeth “aggressively encouraged the use of Rapamune to prevent organ rejection following heart, lung, liver, pancreas, and islet cell transplants, without FDA approval.” Lawmakers have asked Pfizer—which acquired Wyeth in 2009—to provide internal documents specifically detailing Rapamune’s side effects, Reuters reports.
Pfizer said it is fully cooperating with the investigation. In a statement, Pfizer said the FDA had asked Wyeth “to study the drug in the high-immunologic risk patient population (of which African-Americans are often members) to determine whether higher dosing regimes would be beneficial.” It also stated that the FDA authorized “additional dosing information in Rapamune’s label,” although it did not specify what exact information was permitted.
In February, federal prosecutors in Oklahoma began to investigate Wyeth’s promotional practices for Rapamune. Last year, the FDA warned transplant doctors that Rapamune could increase the risk of death in liver transplant patients.
Last month, the oversight panel launched an inquiry into Johnson & Johnson’s infant and children’s medicines.
