Regulatory News In Brief

FDA continues to have significant staffing and management problems, with the device center showing the worst results in a Nov. 19 report issued by the Partnership for Public Service. The report, “The State of the FDA Workforce,” was initiated by the Pew Charitable Trusts as a follow-up to the damning 2007 investigation by FDA’s Science Board finding that the agency’s scientific and technical capabilities were insufficient. (See Also see "FDA Scientific Capacity Inadequate; New Device Technology At Risk" - Medtech Insight, 10 December, 2007..) The latest report found that FDA has made progress since 2007 and has taken steps to expand its workforce. However, it noted that CDRH still has the highest attrition rate of 9.7%, compared to 7.5% in the biologics center and 6.8% in the drug center. This is closely tied to the fact that CDRH employed the highest percentage of temporary staff – 55%, compared to 41% in the drug center and 36% in the biologics center – in fiscal 2010, according to the Partnership’s analysis. The device center also had the highest rate (80%) of newly hired employees who did not join as permanent employees that year. CDRH’s employees were also the least satisfied compared to the other centers in terms of having resources to do their jobs and having their training needs addressed, according to a 2011 Office of Personnel Management survey highlighted by the new report.

The report offered five recommendations to improve the agency’s scientific staffing needs: FDA needs to develop targeted recruitment programs and speed up the hiring process; each of the centers needs...