Group’s Request for FDA Docs on Provenge Denied by Court

A federal appeals court has denied a patient advocacy group’s request to conduct discovery on the FDA to find information on the agency’s initial denial of Dendreon’s application for the prostate cancer treatment Provenge. The U.S. Court of Appeals for the Sixth Circuit says in its ruling that a lower court was correct to deny the request from CareToLive because the FDA had given the group all of the information it had asked for. CareToLive had originally made a Freedom of Information Act request with the FDA in 2007 seeking internal emails and other documents following the agency’s decision not to approve the drug at that time despite an advisory committee’s recommendation.
Washington Drug Letter