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A Look Inside the Provenge Decision: Who's In Charge at FDA?

This article was originally published in RPM Report

Executive Summary

A lawsuit filed by the non-profit group CareToLive charges that political infighting at FDA led the agency to reject Dendreon’s application for the therapeutic prostate cancer vaccine Provenge. The result, the suit claims, was a "successful coup d'etat" on the part of one senior FDA official and a failure to act decisively by his superioirs. The message, however, is broader: FDA and its staff can expect scathing, and now personal, attacks from all sides for safety and efficay decisions; with charges they are too accepting of safety issues or too demanding on efficacy.

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