Posted 18 May 2012
By Alexander Gaffney
The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration's (FDA) and found its employee performance standards to be lagging behind requirements established in federal law.
Under the terms of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), FDA is charged with meeting certain deadlines for reviewing pharmaceutical and medical device products. In return, the agency is given funding in the form of user fees paid for by the sponsors of each product application.
"We recently reported on FDA's timeliness in meeting performance goals related to its review of medical devices," wrote GAO in its report. "As part of that report, we found that FDA had not met a subset of these performance goals."
GAO's report is primarily focused on performance goals at the employee performance level rather than at the aggregate level, which it reported on earlier in May 2012-See Regulatory Focus' 1 May 2012 story, "Report: FDA Meeting Review Goals Under PDUFA."
Investigators looked into standards for employee performance as contained in employee performance plan templates,
GAO's findings in its report, "Employee Performance Standards for the Timely Review of Medical Product Applications," include:
- FDA's employee performance management system is decentralized and paper-based, and different centers use various systems to track high-level summary information.
- Members of the Commissioned Corps, unlike employees of FDA, are not required to have performance plans containing PDUFA or MDUFA goals despite regularly reviewing product applications.
- Though performance timelines are "one aspect of employee performance," they are also weighed with standards for product safety and effectiveness, making a fair assessment of performance difficult.
- Because multiple employees review each product application, assigning responsibility and gauging employee performance is difficult.
- The ultimate responsibility for the agency's performance relative to PDUFA and MDUFA mandates falls on FDA's Center Directors, who are held accountable for results.
- While most staff are directed to meet goals established under PDUFA and MDUFA, FDA emphasis on these goals remains inconsistent across the agency.
While GAO did not make any recommendations in its report to Sens. Richard Burr and Tom Coburn, it seems likely FDA might be pressed to establish changes as the result of the report.
GAO - Employee Performance Standards for the Timely Review of Medical Product Applications