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Pfizer to pay out $35M in Rapamune decision [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) PFIZER WILL PAY $35 million to settle with 41 state attorneys general for alleged off-label mar- keting and promotion of immu- nosuppressive drug Rapamune by legacy company Wyeth, said New York Attorney General Eric Schneiderman. Schneiderman charged Wyeth with promoting the drug for use in liver, heart and drug trans- plants. Rapamune (sirolimus) was first approved by the FDA in 1999 to help patients better tolerate kidney transplants and lessen the chance of rejection. "Patients and consumers need to have confidence in the truth- fulness of claims made to them by medical providers," Schnei- derman stated. The complaint further alleged that Wyeth violated consumer protection laws by misrepresent- ing the drug's uses and benefits through promotional talks and misleading presentations of data. Pfizer acquired Wyeth in 2009 for $68 billion. Neither drug- maker has admitted to liability or wrongdoing. The settlement follows last year's $490.9 million agreement between Pfizer and the Depart- ment of Justice to resolve liability over Rapamune marketing. Of that sum, $257.4 million went to resolve prosecutors' civil claims that Wyeth violated the False Claims Act by promoting the drug for unapproved uses. $233.5 million went towards a criminal fine and forfeiture under a plea agreement with US District Court in Oklahoma City after Wyeth pled guilty to a Federal Food, Drug and Cosmetic Act misbranding violation. -Kevin McCaffrey Schneiderman: Trying to ensure the "truthfulness of claims" (c) 2014 Haymarket Media, Inc. |