GAO: FDA's management system lacks conformity

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A report released by the U.S. Government Accountability Office (GAO) on March 19 found that while the FDA is aware of the challenges it faces as an agency, it has been hesitant to implement strategic planning procedures to fix the problems.

In the report, the GAO addressed the extent to which the FDA’s Strategic Action Plan contains strategies that address management challenges, annual performance measurements, the process that the agency takes to align its resources to support strategic goals and how agency managers apply and report key practices.

Lisa Shames, director of natural resources and environment at the GAO, and Marcia Crosse, the GAO's director of healthcare, wrote: “Since January 2009, we have identified FDA’s oversight of medical products as an area of high risk, based in part on FDA’s failure to conduct adequate and sufficient inspections of foreign manufacturers of drug and medical devices sold in the U.S.”

After evaluating the agency's strategies, the office found that its challenges are in the areas of recruiting, retaining and developing the agency’s workforce, modernizing information systems, coordinating internally and externally, communicating with the public and keeping up with scientific advances.

Additionally, the GAO delivered a survey to agency managers in 2009 to evaluate whether  they thought FDA had made progress in addressing management challenges. The report showed that less than one-half of the respondents reported “great progress” in addressing workplace issues.

The office also found that the “FDA’s 48 annual performance measures for fiscal year 2010 are not as useful for decision makers as they could be because they are only partially results-oriented."

While GAO said a number of the agency's goals work towards addressing some key issues, for the most part they do not address agency outcomes and performance or work to identify performance goals or challenges.

While the report stated that the agency has “taken steps to align its activities and resources to strategic goals, these efforts in its centers and offices are not clear, making it difficult to connect the agency’s use of resources to the achievement of its goals.”

The report also showed that only four of eight FDA centers clearly reported site goals in adherence to the agency’s outlined goals, while only two linked their resources to agency goals.

"The absence of such linkage hinders FDA’s and congressional decision makers’ ability to effectively understand the link between costs and outcomes," GAO stated.

Therefore, the GAO has put forth several recommendations that FDA’s Commissioner should take to initiate change and implement strategies to work towards overall agency improvement:

  • Develop a strategic human capital plan and issue an updated workforce plan to  “more strategically manage” the agency's human capital;
  • Make performance measures more results-oriented to more effectively gauge agency progress;
  • Direct agency centers and offices to align program activities to the agency’s strategic goals. The GAO said that this would use budget requests or center-office-level documents to more clearly outline the alignment of goals;
  • Direct FDA centers and offices to track workload by strategic goals; and
  • Build the agency’s capacity to collect and analyze performance information by expanding management training.

“Along with concerns expressed by others, our work examining strategic planning and management at FDA indicates that the agency is facing significant management challenges that could affect its ability to protect Americans from unsafe and ineffective products,” the report concluded.