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

 
• By CareToLive

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.

On May 8, FDA rejected Dendreon Corp. ’s therapeutic prostate cancer vaccine Provenge with an "approvable" letter asking for additional data that will take the company years to collect. (See "The Provenge Precedent," The RPM Report, May 2007 Also see "The Provenge Precedent" - Pink Sheet, 1 May, 2007..) That action came despite an FDA advisory committee’s overwhelming recommendation to approve the vaccine.

The fallout has spawned a number of lawsuits, including one filed against the Food & Drug Administration by the non-profit patient group CareToLive. The suit accuses FDA, HHS Secretary Michael...

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