The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Freedom of Information Act, some of which the group maintains were deleted, destroyed (see here) or simply not produced in accordance with the law.
In a bid to avoid oral arguments, the FDA has filed a brief arguing that Care To Live and its attorney have made allegations about FDA conduct without factual support; charged Pazdur with lying about his document production; continue to promote a 'conspiracy theory' and engages in 'baseless speculation;' and the group has made 'baseless attacks.' Here is the FDA filing.
Of course, their effort may be overtaken by events, because Dendreon, which makes Provenge, has a May 1 PDUFA date. The real issue, though, is how the FDA handles alleged conflicts. As noted previously, the Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned the proverbial tin ear to this drama. So far, it remains to be seen whether Margaret Hamburg, the new commish, will
is either failing to be more responsive such concerns remains to be seen.