OIG: Many FDAers Still Wary to Air Concerns, Unclear on Dispute Process

The number of internal scientific disagreements over device approvals has waned since late 2009, when the FDA implemented new procedures for handling such disputes, but many employees are still hesitant to raise scientific concerns with agency management, according to a new report by the HHS Office of Inspector General. Overall, the OIG uncovered 36 scientific disagreements between the start of fiscal year 2008 and the end of fiscal 2010, but just nine occurred after the new procedures took effect in October 2009. Of those, six were resolved using the new procedures and three were handled informally, the report states.
Devices & Diagnostics Letter