According to the report, 36 internal scientific disagreements took place at the FDA’s Center for Devices and Radiological Health from fiscal 2008 to fiscal 2010. Disagreements about a device’s 510(k) submission process had the widest range of issues.
“CDRH’s regulatory decisions have significant implications for the public’s health,” the inspector general’s office said in the report. “Therefore, its processes must ensure the scientific integrity and transparency of those decisions. Having robust processes to identify, openly discuss, resolve and document disagreements among multiple reviewers contributes to that integrity.”
The FDA issued a directive in January 2009 to strengthen procedures to address scientific disagreements and CDRH later released new procedures to deal with scientific disagreements in October of that year.
However, about half of the reviewers and one-quarter of the managers who responded to HHS’ survey said they had not been trained in the new procedures.
About 20% of respondents said they were concerned that expressing a scientific disagreement to a manager would “adversely affect their careers” despite a CDRH policy that the agency support a work environment where staff are free to express scientific disagreements without fear of retaliation.