“FDA sued over Provenge delay” (url)
http://seattletimes.nwsource.com/html/businesstechnology/2003813806_dendreon31.html
Tuesday, July 31, 2007 -
By Ángel González
Seattle Times business reporter
A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval of the Seattle company’s genetically engineered therapy in May.
The plaintiffs say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency.
The lawsuit, filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy.
The suit doesn’t skimp on harsh words for the FDA.
"There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency," the lawsuit says.
The lawsuit is the latest episode in a case that has stirred intense debate and deep emotions among patients, investors and industry observers.
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