POGO Lambastes FDA Over Conflict of Interest Report
Posted 13 January 2012 | By
The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p
For further background, please see prior Regulatory Focuscoverage here.
The group, which calls itself a "nonpartisan independent watchdog" issued a lengthy public letter to FDA Commissioner Margaret Hamburg on Thursday. The letter asks Hamburg to investigate the perceived conflicts of interests that occurred on the Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee joint committee meeting on the drospirenone oral contraceptives.
The Bayer drugs Yaz and Yasmin are the best-selling drospirenone products.
All four members of the Advisory Committee that were deemed by POGO to have conflicts of interest in favor of the drospirenone voted to keep it on the market.
The letter also calls for Hamburg to address the safety concerns over drospirenone , and for FDA's draft guidelines on providing financial transparency on advisory committee panelists to be overhauled in light of the issues addressed in the letter.
"Looking ahead, POGO asks that when dealing with any question of an FDA expert's impartiality, the information be made public, and without delay," said POGO's Adam Zagorin.