Who Will Lead FDA In The Future? Succession Plan Is Not Enough, GAO Says

In its latest report card on FDA, the Government Accountability Office examines the agency's management of such challenges as recruiting and retaining its workforce and communicating with the public.

While the GAO acknowledges that FDA has made progress in strategic planning and management, it cited the need for improvement. Most notably, it recommends that FDA develop a strategic human capital plan and update its workforce plan.

GAO specifically looked at FDA's management of recruiting, retaining and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances.

With regard to the first point, the report notes that after receiving an increase in appropriations in fiscal year 2008, the agency went on a hiring binge and added more than 2,500 employees in fiscal years 2008 and 2009. In addition, FDA created a fellowship program in 2008 to attract scientists to work with mentors in different areas of regulatory science.

Succession Plan Not Enough, GAO Says

Among other actions, the Center for Drug Evaluation and Research is developing courses on management and communication. And in September 2009, FDA completed an agencywide succession plan, identifying anticipated leadership gaps and workforce needs over the next several years.

But despite these advances, the report says FDA managers cited the need to further bolster the agency's workforce as a top priority. GAO's report was based on interviews with FDA and HHS officials and a Web-based survey of more than 400 FDA managers, of whom more than 300 responded.

"While officials told us that its centers and offices are engaging in some strategic human capital efforts, FDA does not have an agencywide strategic human capital plan or an up-to-date workforce plan to coordinate these efforts and guide its overall human capital management," the report states.

GAO notes that while FDA recently issued an agencywide succession plan it has not updated its 2006 workforce plan and thus lacks a tool to determine staffing needs.

HHS sent GAO a letter responding to the report in which it said FDA is in the process of developing a strategic human capital plan. The agency awarded a contract to support development of the plan in September 2009.

The agency has acknowledged the need to bolster its staff. FDA's Chief Scientist Jesse Goodman said at a March 24 Capitol Hill briefing on FDA's scientific progress that the agency needed to improve the education of its junior and mid-level staff. He said he thought it would take five to 10 years for the agency to restore itself as the scientific leader it once was (¹ (Also see "FDA Needs 5 To 10 Years Of Rebuilding, Chief Scientist Goodman Says" - Pink Sheet, 24 Mar, 2010.)).

Performance Assessment Should Look At Results

GAO's report on FDA management was requested by Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, and Rep. Greg Walden, R-Oregon, ranking member of the Subcommittee on Oversight and Investigations. It is far less critical of the agency than other recent GAO reports. Earlier this month, the congressional watchdog group issued a report critical of FDA's oversight of its criminal and misconduct investigations (² (Also see "Pfizer Says Government Investigations Must Be Avoided, Since "There Is No Way Of Winning" Once They Start" - Pink Sheet, 8 Mar, 2010.)).

In its current report, GAO recognized FDA's efforts to improve its information technology systems, but said managers reported a need for improvement. And it gave a nod of approval to the agency's greater communication with the public, including the strategic plan on risk communication (³ (Also see "FDA Will Review Need For New Laws On Drug Promotion" - Pink Sheet, 30 Sep, 2009.)) and the Transparency Task Force (⁴ (Also see "Jenkins Suggests "Complete Response" Letter Transparency Could Prompt Better Drug Applications, Faster Reviews" - Pink Sheet, 7 Dec, 2009.)).

In addition to calling for a human capital plan, GAO also recommended that FDA improve its measurement of performance by making it more results-oriented; that the agency's main centers and offices more clearly align their program activities to FDA's strategic goals; that centers and offices track their workload by strategic goals; and that the commissioner expand training for managers on topics related to performance.

HHS said FDA agrees with these recommendations and is well on the way to implementing many of them. For example, HHS said FDA is developing a new comprehensive performance tracking and management system, which it will implement in fiscal year 2010.

- Brenda Sandburg ( ⁵ [email protected] )