GAO Report Criticizes FDA's Strategic Planning and Management Efforts

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Government Accountability Office issued a report that's largely critical of FDA's efforts to fully use practices for effective strategic planning and management.

The US Government Accountability Office (GAO) issued a report, Food and Drug Administration: Opportunities Exist to Better Address Management Challenges, in which it is largely critical of FDA’s efforts to fully use practices for effective strategic planning and management. GAO issued the report on Feb. 19, 2010 and posted the full report on its website on Mar. 23, 2010.

The GAO report examined four major areas:

• The extent to which FDA’s Strategic Action Plan contains strategies to address its management challenges and the progress FDA has made in addressing those challenges
• The extent to which FDA’s annual performance measures are results-oriented
• The extent to which FDA has aligned its activities and resources to support its strategic goals
• The extent to which FDA managers report using performance information in decision-making and applying key practices to encourage that use

GAO found that “while FDA is aware of its challenges and has taken steps to address them, the agency does not fully use practices for effective strategic planning and management,” according to the report. GAO identified five major management challenges that could affect FDA’s ability to carry out its mission: recruiting, retraining, and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances.

Some specific findings of the report show that less than one-half of FDA managers reported “great progress” in addressing workforce issues. GAO also found that FDA lacks an agency-wide strategic human-capital plan, which reduces the agency’s ability to strategically strengthen itself in this area.

The report also found that FDA’s 48 annual performance measures for fiscal year 2010 are only partially results-oriented. Although GAO acknowledged that some measures adhere to key agency goals, it concludes that “FDA measures do not adhere to other key characteristics because they do not focus on outcomes, address important dimensions of agency performance, identify projected levels of performance for multiyear goals, or fully address identified management challenges.”


The GAO said that FDA has aligned its three major activities-premarket review, production oversight, and postmarket surveillance-and uses employee performance plans to link individual activities to its strategic goals. However, only four of eight centers and offices that GAO reviewed clearly document alignment of their activities to FDA’s goals, and only two clearly linked their resources to the agency’s goals.

GAO issued several recommendations to address these problems, and which FDA has agreed with, according to GAO. These recommendations direct the FDA commissioner to do the following:

• Develop a strategic human-capital plan and issue an updated workforce plan
• Work to make FDA’s performance measures more results-oriented
• Following the creation of more results-oriented sets of performance measures, direct FDA’s centers and offices to track their workload by strategic goals
• Direct each of the agency’s main centers and offices to clearly align their program activities to FDA’s strategic goals in documents such as the budget request or center- or office-level documents
• Build FDA’s capacity to collect and analyze performance information by expanding training for managers on topics related to performance information

According to GAO, FDA is working on these recommendations. GAO plans to provide updated information on the implementation of these measures by FDA.