One month after a non-profit group accused the FDA of violating the Freedom of Information Act by failing to provide documents, the agency has forked over paperwork indicating FDA commish Andy von Eschenbach did hear from two panel members who last year urged him not to approve the Provenge prostate-cancer vaccine.
The non-profit, Care To Live, filed a lawsuit against the FDA after the agency last spring overruled one of its advisory panels, which recommended approval of the Dendreon vaccine. At the time, no one knew that two panel members took the unusual step of writing letters to Andy in hopes that he would direct the agency to delay approval. The move was allegedly orchestrated as part of a Byzantine powerplay at the agency, according to the non-profit, which also accused the two panel members of harboring undisclosed financial conflicts of interest.
The letters were written by Howard Scher, an oncologist at Memorial Sloan-Kettering Cancer who serves on the advisory board of a venture capital firm that invested in Novacea, which is developing a rival cancer med. The other was Maha Hussain, a University of Michigan oncologist. Last month, though, the FDA responded to a FOIA request by the non-profit and indicated Andy's office couldn't locate any 'responsive records' concerning the letters, despite a ‘diligent search.’
Yet, there was evidence that key letters and memos were either addressed to him directly or he was among those listed to receive copies. You can read about that right there. Now, the FDA has turned over copies of not only the letters written by Scher and Hussain to von Eschenbach, but also the e-mails they wrote him directly, which indicates the material was received by his office. (Take a look at these).
Setting aside the debate over Provenge, the belated effort to locate documents - which came only after a lawsuit and court filings accusing the FDA of violating the FOIA - doesn't speak well of the agency. There may not have been any bad behavior involved, but this is the sort of problem that members of Congress complain is a regular impediment to their efforts to better understand FDA workings. Given that HHS Secretary Mike Leavitt may face contempt charges for failing to turn over documents related to the Ketek antibiotic investigation, perhaps Andy and his staff thought twice.