Pfizer has disclosed a $491 million charge for a Rapamune marketing settlement, fiercepharma.com reports, citing Dow Jones.
The company made a deal with the US Justice Department to resolve the long-standing probe, which Pfizer inherited when it bought Wyeth in 2009. The drug maker had faced allegations that Wyeth pushed Rapamune for unapproved uses, and that it used kickbacks to persuade doctors. In 2010, the feds joined a whistleblower case, filed by two former Wyeth salespeople, claiming that the company not only touted the organ-transplant drug for off-label use, but specifically targeted hospitals that mostly treated African-Americans, despite higher risks in those patients.
At the time, Pfizer said that it welcomed the government’s involvement in that case. “(W)e believe its doing so will allow for a more orderly process and efficient conclusion” of the lawsuit and the federal probe, the company said. After all, the alleged misconduct did not extend past 2007, Pfizer pointed out, two years before it bought Wyeth.
Pfizer said that it is committed to marketing Rapamune according to its FDA-approved label. The company also said that the transplant drug was “never contraindicated” for African-American patients or “or other high-risk populations.”
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