GAO 

United States Government Accountability Office

Report to Congressional Requesters

FOOD AND DRUG 

ADMINISTRATION 

Opportunities Exist 

to Better Address 

Management 

Challenges 

February 2010 

GAO-10-279 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

February 2010

FOOD AND DRUG ADMINISTRATION

Opportunities Exist to Better Address Management 

Challenges

Highlights of GAO-10-279, a report to 

congressional requesters 

GAO was asked to review the Food 

and Drug Administration’s (FDA) 

strategic planning and 

management. Leading practices in 

this area include developing 

strategies to address management 

challenges and results-oriented 

performance measures, aligning 

activities and resources to strategic 

goals, and enhancing the use of 

performance information. In this 

report, GAO examined the extent 

to which (1) FDA’s Strategic Action 

Plan contains strategies to address 

its management challenges, and the 

progress FDA has reported in 

addressing those challenges; 

(2) FDA’s annual performance 

measures are results-oriented; 

(3) FDA has aligned its activities 

and resources to support its 

strategic goals; and (4) FDA 

managers report using 

performance information in 

decision making and applying key 

practices to encourage that use. 

GAO surveyed FDA managers; 

analyzed reports on FDA to identify 

its management challenges; 

reviewed FDA and other 

documents, prior GAO work, and 

surveys of federal managers; and 

interviewed FDA officials. 

What GAO Recommends

GAO recommends that the 

Commissioner of FDA take several 

actions to improve FDA’s strategic 

planning and management, such as 

developing a strategic human 

capital plan and working to make 

the agency’s performance 

measures more results-oriented. 

FDA agreed with the 

recommendations. 

Overall, 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. GAO identified five major management challenges that 

could affect FDA’s ability to carry out its mission, and while FDA’s 2007 

Strategic Action Plan contains strategies to address these challenges, progress 

has been uneven. Through reviewing reports from GAO, the Institute of 

Medicine, the Department of Health and Human Services, and the FDA 

Science Board, GAO determined that FDA’s management challenges include 

recruiting, retaining, and developing its workforce; modernizing its 

information systems; coordinating internally and externally; communicating 

with the public; and keeping up with scientific advances. GAO’s 2009 survey 

asked FDA managers whether they thought the agency had made progress in 

addressing its management challenges. A minority of FDA managers 

responding to the survey reported that the agency was making great progress 

on meeting most of these challenges—the exception was for public 

communication. For example, less than one-half of FDA managers reported 

great progress in addressing workforce issues. GAO also found that FDA lacks 

an agencywide strategic human capital plan, which reduces the agency’s 

ability to strategically strengthen its human capital. 

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 resultsoriented. The measures adhere to some of the key characteristics GAO 

identified in prior work that can help provide decision makers with useful 

information on an agency’s results—for example, they are linked to agency 

goals. However, FDA’s 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. 

While FDA 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. FDA 

has aligned its three main types of activities—pre-market review, production 

oversight, and post-market surveillance—and uses employee performance 

plans to link individuals’ activities to its strategic goals. However, only four of 

eight centers and offices GAO reviewed clearly documented alignment of their 

activities to FDA’s goals, and only two clearly linked their resources to goals, 

in part because several centers and offices do not track workload by goals. 

In GAO’s survey, about one-third to one-half of FDA managers reported using 

performance information to a great extent in making management decisions—

for example, to set program priorities. While training can develop agency 

capacity to use performance information, less than one-half of FDA managers 

reported receiving training that could improve and expand the use of 

performance information. 

View GAO-10-279 or key components.

To view the e-supplement online, click 

on GAO-10-280SP. 

For more information, contact Lisa 

Shames at (202) 512-3841 or 

shamesl@gao.gov, or Marcia Crosse at 

(202) 512-7114 or crossem@gao.gov. 
Page i GAO-10-279 

Contents 

Letter 1

Background 5 

FDA’s Strategic Action Plan Contains Strategies to Address 

Identified Management Challenges, but the Progress FDA 

Reported Has Been Uneven 8 

FDA’s Annual Performance Measures Are Only Partially ResultsOriented 17 

Although Some Progress Has Been Made, Alignment of Activities 

and Resources to Strategic Goals Is Unclear at the Center and 

Office Level 21 

About One-half or Fewer FDA Managers in Our Survey Reported 

Extensive Use of Performance Information and Application of 

Practices to Encourage Its Use 26 

Conclusions 31 

Recommendations for Executive Action 32 

Agency Comments and Our Evaluation 32 

Appendix I Objectives, Scope, and Methodology 35 

Appendix II Crosswalk of FDA’s Strategic Goals and Objectives 

to Fiscal Year 2010 Performance Measures 42 

Appendix III Comments from the Department of Health and 

Human Services 43 

Appendix IV GAO Contacts and Staff Acknowledgments 48 

Related GAO Products 49 

 FDA's Planning and Management 
Tables 

Table 1: Identified Management Challenges and Examples of 

Related Strategies in FDA’s 2007 Strategic Action Plan 9 

Table 2: Number of FDA’s Fiscal Year 2010 Performance Measures, 

by Center and Office 19 

Figures 

Figure 1: FDA’s Main Organizational Structure, as of August 2009 6 

Figure 2: FDA Managers’ Survey Responses on Areas That Would 

Improve Their Ability to Contribute to Meeting FDA’s 

Goals and Responsibilities, Compared with FDA 

Managers’ Reporting of Progress Made in Those Areas, by 

Related Management Challenge 11 

Figure 3: Percentage of FDA Managers Reporting Great Use of 

Performance Information for Selected Management 

Decisions 27 

Figure 4: Percentage of FDA Managers Reporting Extensive 

Application of Selected Practices to Encourage the Use of 

Performance Information 29 

Figure 5: Percentage of FDA Managers Reporting That They 

Received Six Types of Training Related to Performance 

Information 30 

Page ii GAO-10-279 FDA's Planning and Management
Abbreviations 

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention 

CDER Center for Drug Evaluation and Research 

CDRH Center for Devices and Radiological Health 

CFSAN Center for Food Safety and Applied Nutrition 

CVM Center for Veterinary Medicine 

FDA Food and Drug Administration 

FSIS Food Safety and Inspection Service 

FSWG Food Safety Working Group 

GPRA Government Performance and Results Act of 1993 

HHS Department of Health and Human Services 

IOM Institute of Medicine 

IT information technology 

NCTR National Center for Toxicological Research 

OC Office of the Commissioner 

OMB Office of Management and Budget 

OPM Office of Personnel Management 

ORA Office of Regulatory Affairs 

USDA U.S. Department of Agriculture 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately. 

Page iii GAO-10-279 FDA's Planning and Management
Page 1 GAO-10-279 

 

United States Government Accountability Office

Washington, DC 20548 

 

February 19, 2010 

The Honorable Joe Barton 

Ranking Member 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Greg Walden 

Ranking Member 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Over the past several years, we and others have raised concerns about the 

ability of the Food and Drug Administration (FDA)—an agency within the 

Department of Health and Human Services (HHS)—to meet the regulatory 

responsibilities associated with its mission. That mission is to ensure the 

safety and efficacy of medical products, such as drugs and medical 

devices, sold in the United States; ensure the safety of roughly 80 percent 

of the nation’s food supply; and, most recently, regulate tobacco products 

sold in the United States.1

 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 United States.2

Similarly, in 2007, we identified the federal oversight of food safety as an 

area of high risk and called for a governmentwide reexamination of the 

food safety system.3

 In 2008, we reported that FDA’s oversight of domestic 

and imported fresh produce was limited, and we made several 

recommendations to improve this oversight.4

 Other entities, such as the 

1

Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, div. A, 123 Stat. 

1776 (2009). The act, among other things, provides FDA with the authority to regulate 

tobacco products under the Federal Food, Drug, and Cosmetic Act. 

2

GAO, High-Risk Series: An Update, GAO-09-271 (Washington, D.C.: January 2009). 

3

GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007). 

4

GAO, Food Safety: Improvements Needed in FDA Oversight of Fresh Produce, 

GAO-08-1047 (Washington, D.C.: Sept. 26, 2008). 

 FDA's Planning and Management 
 

Institute of Medicine (IOM) and the FDA Science Board,5 have also raised 

serious concerns about FDA’s ability to meet its regulatory 

responsibilities. For example, in November 2007, the Science Board 

reported that FDA’s mission was at risk due to various management 

challenges the agency faced, such as poor information technology (IT) 

infrastructure. The Science Board recommended, among other things, an 

infusion of resources. Subsequently, Congress increased appropriations to 

the agency for fiscal years 2008, 2009, and 2010. 

Strategic planning and management can help agencies effectively manage 

resources and fulfill their mission, and, since the mid-1990s, we have 

reported on leading practices for effective strategic planning and 

management.6

 These practices include establishing long-term goals that 

support the agency’s mission, identifying and developing strategies to 

address key management challenges, and aligning resources and activities 

to agency goals. These practices also include developing results-oriented 

performance measures, among other things, to gauge an agency’s progress 

toward achieving its mission or its program-related goals. Applying these 

measures, managers can collect and track data about management issues, 

referred to as performance information. They then can use the resulting 

performance information to guide decision making and improve results. 

HHS has a strategic plan that includes goals related to FDA. In addition, 

FDA developed its own Strategic Action Plan in Fall 2007 to guide its work 

and help it to fulfill its mission.7

 In light of the many concerns about FDA’s 

 

5

The FDA Science Board provides advice to the Commissioner on, among other things, 

specific complex and technical issues as well as emerging issues within the scientific 

community, in industry, and in academia. See FDA Science Board, Subcommittee on 

Science and Technology, FDA Science and Mission at Risk (Rockville, Md.: November 

2007). 

6

GAO, Managing for Results: Enhancing Agency Use of Performance Information for 

Management Decision Making, GAO-05-927 (Washington, D.C.: Sept. 9, 2005); Agency 

Performance Plans: Examples of Practices That Can Improve Usefulness to 

Decisionmakers, GAO/GGD/AIMD-99-69 (Washington, D.C.: Feb. 26, 1999); Agencies’ 

Annual Performance Plans Under the Results Act: An Assessment Guide to Facilitate 

Congressional Decisionmaking, GAO/GGD/AIMD-10.1.18 (Washington, D.C.: February 

1998); Managing for Results: Critical Issues for Improving Federal Agencies’ Strategic 

Plans, GAO/GGD-97-180 (Washington, D.C.: Sept. 16, 1997); and Executive Guide: 

Effectively Implementing the Government Performance and Results Act, 

GAO/GGD-96-118 (Washington, D.C.: June 1996). 

7

Department of Health and Human Services, U.S. Food and Drug Administration, FDA 

Strategic Action Plan: Charting Our Course for the Future (Rockville, Md.: Fall 2007). 

Page 2 GAO-10-279 FDA's Planning and Management
 

ability to meet its mission, you asked us to review the effectiveness of the 

agency’s strategic planning and management efforts. In this report, we 

examine the extent to which (1) FDA’s Strategic Action Plan contains 

strategies to address its management challenges, and the progress FDA 

has reported in addressing those challenges; (2) FDA’s annual 

performance measures are results-oriented; (3) FDA has aligned its 

activities and resources to support its strategic goals; and (4) FDA 

managers report using performance information in decision making and 

applying key practices to encourage that use. 

To conduct our review, we examined laws, regulations, guidance, and 

leading practices related to FDA and strategic planning. We also reviewed 

FDA documents, surveyed agency managers, and interviewed FDA and 

HHS officials. In addition, to address our first and fourth objectives, we 

conducted a Web-based survey of FDA managers from June through 

August, 2009. We selected a random, stratified sample of over 400 

managers from a population of over 1,200. Over 300 respondents, or about 

70 percent of our sample, completed the questionnaire. The survey results 

can be generalized to the entire population of FDA managers. To produce 

such results, we based our estimates on all respondents who completed 

our survey, including those not answering a particular question or those 

providing the following answer: “no basis to judge/not applicable.” We 

used this same method in our previous governmentwide surveys on 

performance and management issues. All percentage estimates in this 

report have a margin of error of plus or minus 10 percentage points or less. 

Our survey asked FDA managers to provide one of the following five 

responses to our questions: “no extent,” “small extent,” “moderate extent,” 

“great extent,” and to a “very great extent.” In reporting FDA managers’ 

responses, we refer to responses in the categories of “great” or “very 

great” extent as “great.” We are also issuing an electronic supplement to 

this report that shows a more complete tabulation of our survey results.8

To identify FDA’s management challenges, we reviewed relevant GAO, 

IOM, HHS, and FDA Science Board evaluations of FDA since January 2007. 

To determine whether FDA’s 2007 Strategic Action Plan contains 

strategies to address these challenges, we compared the challenges we 

identified with our analysis of FDA’s Strategic Action Plan and verified this 

 

8

GAO, Food and Drug Administration: 2009 FDA Managers Survey on Performance and 

Management Issues, an E-supplement to GAO-10-279, GAO-10-280SP (Washington, D.C.: 

February 2010). 

Page 3 GAO-10-279 FDA's Planning and Management
 

analysis with FDA officials. To examine the progress that FDA has 

reported toward meeting identified challenges, we reviewed prior GAO 

and FDA Science Board assessments of FDA as well as documentation 

that FDA provided to us in which it reported its efforts to address 

identified management challenges since developing its Strategic Action 

Plan. We also examined FDA managers’ responses to questions in our 2009 

survey related to these challenges. To analyze responses to our openended questions, two GAO analysts independently reviewed and 

categorized each response, then reconciled any differences in their 

independent categorizations. We reported on examples that were 

illustrative of the responses in any given category. 

To determine the extent to which FDA’s annual performance measures are 

results-oriented, we identified several selected characteristics of resultsoriented performance measures from prior GAO work.9

 We compared 

these characteristics with the 48 performance measures included in the 

President’s fiscal year 2010 budget request for FDA. These performance 

measures are linked to and organized by FDA’s main centers and offices. 

To determine the extent to which FDA has aligned its activities and 

resources to its strategic goals, we reviewed leading practices on effective 

strategic alignment from prior GAO work and Office of Management and 

Budget (OMB) guidance.10 We determined the extent to which FDA was 

consistent with these leading practices by comparing FDA’s strategic goals 

from its 2007 Strategic Action Plan with information on the agency’s 

activities and resources. This information included the fiscal years 2009 

and 2010 budget requests, strategic planning documents from FDA’s main 

centers and offices, background documentation on the agency’s employee 

time reporting systems, and examples of individual employees’ 

performance plans. To review FDA managers’ use of performance 

information in decision making, we analyzed responses to seven questions 

in our 2009 survey measuring managers’ reported use of performance 

information to make different management decisions. To review FDA 

managers’ reported application of practices to encourage the use of 

performance information, we analyzed responses to four other questions 

in our 2009 survey that measured managers’ reported use of practices to 

encourage the use of performance information. We compared our survey 

 

9

GAO/GGD/AIMD-10.1.18 and GAO/GGD/AIMD-99-69. 

10GAO, Results-Oriented Government: GPRA Has Established a Solid Foundation for 

Achieving Greater Results, GAO-04-38 (Washington, D.C.: Mar. 10, 2004); GAO/GGD-96-118; 

and Office of Management and Budget, Executive Office of the President, OMB Cir. No. 

A-11, Preparation, Submission, and Execution of the Budget, Sec. 220, p. 1 (2009). 

Page 4 GAO-10-279 FDA's Planning and Management
 

results with the results of an earlier 2007 survey we conducted of federal 

managers across the federal government.11 (See app. I for more details on 

our scope and methodology.) 

We conducted our work from December 2008 to February 2010 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, 

appropriate evidence to provide a reasonable basis for our findings and 

conclusions based on our audit objectives. We believe that the evidence 

obtained provides a reasonable basis for our findings and conclusions 

based on our audit objectives. 

In this section, we discuss FDA’s responsibilities and organizational 

structure, as well as leading practices for effective strategic planning and 

management under the Government Performance and Results Act of 1993 

(GPRA) that relate to our reporting objectives.12

Background 

FDA Responsibilities and 

Organizational Structure 

Under the Federal Food, Drug, and Cosmetic Act, FDA’s public health 

responsibilities are, among other things, to ensure the safety and 

effectiveness of medical products—drugs, biologics, and medical 

devices—marketed in the United States; ensure the safety of nearly all 

food products other than meat and poultry; and, recently, regulate tobacco 

products.13 FDA carries out these responsibilities through six regulatory 

product centers; its Office of Regulatory Affairs (ORA), which performs 

fieldwork, such as inspections and enforcement activities, on behalf of all 

the product centers; and its research arm, the National Center for 

Toxicological Research (NCTR).14 Each center and office has distinct 

 

11The results of our 2007 survey are available in the following GAO reports: Government 

Performance: Lessons Learned for the Next Administration on Using Performance 

Information to Improve Results, GAO-08-1026T (Washington, D.C.: July 24, 2008); and 

Government Performance: 2007 Federal Managers Survey on Performance and 

Management Issues, an E-supplement to GAO-08-1026T, GAO-08-1036SP (Washington, 

D.C.: July 24, 2008). 

12Pub. L. No. 103-62, 107 Stat. 285. 

1321 U.S.C. §§ 301 et seq. 

14Because the Office of Foods was not established until August 7, 2009, and the Center for 

Tobacco Products was not established until August 19, 2009, we did not include them in 

our review. 

Page 5 GAO-10-279 FDA's Planning and Management
 

responsibilities. For example, the Center for Devices and Radiological 

Health (CDRH) is responsible for ensuring that medical devices are safe 

and effective and establishes performance standards for radiation-emitting 

electronic products. Figure 1 shows FDA’s main organizational structure, 

as of August 2009. 

Figure 1: FDA’s Main Organizational Structure, as of August 2009 

Office of the Commissioner 

Source: FDA.

Center for

Biologics

Evaluation

and Research

Center for 

Devices and 

Radiological 

Health 

Center for Drug 

Evaluation and 

Research 

Center for 

Tobacco 

Products

Office 

of Regulatory 

Affairs

National Center 

for Toxicological 

Research 

Center for

Food Safety

and Applied

Nutrition

Center for 

Veterinary

Medicine 

Office

 of Foods

Selected Leading Practices 

for Effective Strategic 

Planning and Management 

under GPRA 

GPRA requires executive agencies to complete strategic plans that define 

their missions, establish results-oriented goals, and identify the strategies 

that will be needed to achieve those goals. While the HHS strategic plan 

fulfills this requirement for its operating divisions, including FDA, FDA has 

voluntarily developed its own Strategic Action Plan, which it ties to the 

HHS strategic plan. Under GPRA, executive agencies are also required to 

prepare annual performance plans that articulate performance measures 

for the upcoming fiscal year and to report annually on their progress in 

program performance reports. These reports are intended to provide 

important information to agency managers, policymakers, and the public 

on what each agency accomplished with the resources it was given. 

In our prior work, we have identified a variety of leading practices for 

successful strategic planning associated with GPRA that relate to our 

reporting objectives. As we have noted, these practices can help an agency 

Page 6 GAO-10-279 FDA's Planning and Management
 

achieve its strategic goals and its mission. Some of these practices include 

the following: 

• Developing strategies to address key management challenges: We have 

reported that this practice can improve the quality of strategic plans and 

provide a pathway to meeting an agency’s long-term strategic goals.15

• Creating results-oriented performance measures: Such measures can be 

helpful in guiding decisions and assessing performance. We identified 

practices from our previous work that can help agencies establish 

performance measures with results-oriented characteristics.16 Specifically, 

results-oriented performance measures 

• link to agency and departmental strategic goals, 

• include explanatory information on the measures, 

• show baseline and trend data for past performance, 

• use intermediate measures to show progress or contribution to 

intended results, 

• focus on expected results by including outcome measures whenever 

possible, 

• address important dimensions of program performance, 

• identify projected target levels of performance for multiyear goals, and 

• address mission-critical management challenges. 

• Aligning activities and resources to support mission-related goals:17 This 

practice can provide Congress and agency decision makers with a better 

understanding of how the allocation of resources affects mission 

achievement. 

 

15GAO/GGD-97-180. 

16GAO/GGD/AIMD-99-69 and GAO/GGD/AIMD-10.1.18. 

17GAO/GGD-96-118. 

Page 7 GAO-10-279 FDA's Planning and Management
 

• Enhancing the use of performance information: In our prior work, we 

have observed that agencies can take steps to encourage the use of 

performance information by employing specific management approaches 

or tools, such as demonstrating management commitment or developing 

agency capacity to effectively use performance information.18 These tools 

can lead to the improved use of performance information, which can 

support planning and decision-making functions, which can lead to 

improved results. 

Through a review of GAO, HHS, IOM, and FDA Science Board reports on 

FDA, we identified five major management challenges that could affect 

FDA’s ability to carry out its mission. FDA’s 2007 Strategic Action Plan 

contains strategies to address each of these five challenges. While FDA has 

reported efforts to address these five challenges, we found that this 

progress has been uneven. 

FDA’s Strategic Action 

Plan Contains 

Strategies to Address 

Identified 

Management 

Challenges, but the 

Progress FDA 

Reported Has Been 

Uneven 

FDA’s Strategic Action 

Plan Includes Strategies to 

Address Each of Its Five 

Identified Management 

Challenges 

We reviewed evaluations of FDA from GAO, HHS, IOM, and the FDA 

Science Board, and identified five major management challenges that 

could affect FDA’s ability to carry out its mission. These management 

challenges are (1) recruiting, retaining, and developing a workforce with 

the knowledge, skills, and abilities necessary to carry out its mission; 

(2) modernizing information systems, including increasing access to 

outside data; (3) coordinating internally—among its centers and offices—

and externally with other parts of the federal government and outside 

experts; (4) keeping pace with scientific advances necessary to regulate a 

diverse and expanding product base; and (5) communicating timely and 

appropriate product safety information with the public. 

FDA’s 2007 Strategic Action Plan contains strategies—that is, objectives 

and specific planned actions under the agency’s main goals—to address 

 

18GAO-05-927. 

Page 8 GAO-10-279 FDA's Planning and Management
 

each of the five management challenges we identified. Specifically, FDA’s 

Strategic Action Plan includes at least one strategy for each of the five 

management challenges. For example, in its Strategic Action Plan, FDA 

lists four objectives related to its management challenge on modernizing 

information, and, for each of these four objectives, the plan identifies 

specific actions such as modernizing its IT platform. See table 1 for 

additional examples. 

Table 1: Identified Management Challenges and Examples of Related Strategies in FDA’s 2007 Strategic Action Plan 

Examples of related strategies in FDA’s 2007 Strategic Action Plan 

Management challenge Objectives Specific planned actions 

Recruiting, retaining, and 

developing a workforce 

Strengthen the scientific foundation of FDA’s 

regulatory mission 

Establish a 2-year FDA fellowship program 

Modernizing information 

systems 

Strengthen FDA’s base of operations 

Improve information systems for problem detection 

and public communication about product safety 

Improve the medical product review process to 

increase the predictability and transparency of 

decisions using the best available science 

Detect safety problems earlier and better target 

interventions to prevent harm to consumers 

Modernize FDA’s IT platform 

Expand agency officials’ real-time access to 

information related to crises and emergencies 

Pre-market information tracking warehouse 

Develop risk-based modeling to identify 

inspection priorities 

Coordinating internally and 

externally 

Enhance partnerships and communications 

Cultivate a culture that promotes transparency, 

effective teamwork, and mutual respect and ensures 

integrity and accountability in regulatory decision 

making 

Establish the White Oak campus as the new 

venue for scientific and cultural synergy 

Develop FDA teamwork best practices 

Keeping pace with 

scientific advances 

Strengthen the science that supports product safety 

Increase the number of safe and effective new 

medical products available to patients 

Prevent safety problems by modernizing sciencebased standards and tools to ensure high-quality 

manufacturing, processing, and distribution 

Develop novel technologies for rapid pathogen 

detection 

Develop new trial designs for a new era 

Develop novel technologies for quality 

evaluations of complex biological products 

Communicating product 

safety information to the 

public 

Enhance partnerships and communications 

Provide patients and consumers with better access to 

clear and timely risk-benefit information for medical 

products 

Provide consumers with clear and timely information 

to protect them from foodborne illness and promote 

better nutrition 

Establish an FDA risk communication advisory 

committee 

Publish an electronic newsletter on post-market 

drug safety findings 

Promote healthy choices by enhancing consumer 

nutrition information 

Source: GAO analysis of FDA’s 2007 Strategic Action Plan. 

Note: This table provides examples of strategies from FDA’s 2007 Strategic Action Plan related to 

GAO’s identified management challenges. A particular strategy can relate to multiple management 

challenges. The table is intended to be illustrative, rather than a complete list of all applicable 

strategies for each identified management challenge. 

Page 9 GAO-10-279 FDA's Planning and Management
 

FDA Has Reported Efforts 

to Address Management 

Challenges, but the 

Progress FDA Reported 

Has Been Uneven 

FDA has reported efforts to address each of its five identified management 

challenges, but the progress FDA reported has been uneven. For example, 

to meet the challenge of recruiting, retaining, and developing a workforce, 

FDA has reported meeting internal hiring targets in fiscal years 2008 and 

2009. However, because the agency still lacks both a strategic human 

capital plan and an updated workforce plan, its ability to strengthen its 

human capital is reduced. Similarly, to address the challenge of 

modernizing its information systems, FDA has launched new 

modernization projects and designed policies for investment and project 

management, but the agency does not have a comprehensive IT strategic 

plan, among other things, which limits FDA’s assurance that it will be able 

to modernize effectively. To improve its communication with the public, 

FDA has reported a variety of efforts, and a majority of FDA managers 

indicated in our survey that the agency was making great progress in this 

area. 

Figure 2 provides a summary of FDA managers’ survey responses related 

to four of GAO’s identified management challenges. 

Page 10 GAO-10-279 FDA's Planning and Management
 

Figure 2: FDA Managers’ Survey Responses on Areas That Would Improve Their Ability to Contribute to Meeting FDA’s Goals 

and Responsibilities, Compared with FDA Managers’ Reporting of Progress Made in Those Areas, by Related Management 

Challenge 

0 10 20 30 40 50 60 70 80 90 100

''

''

''

''

''

''

Estimated percentage

Progress made improving information technology and information management

Progress made keeping pace with scientific advances necessary to regulate

a diverse and expanding product base

80

43

79

39

70

28

19

49

67

36

Source: GAO.

Additional staff with needed knowledge, skills, and abilities

would improve my ability to contribute

Progress made recruiting, retaining, and developing a workforce with 

knowledge, skills, and abilities necessary to carry out the mission

Updated technologies or other tools for data sharing or

information management would improve my ability to contribute

Progress made improving coordination and communication

with other federal agencies

Improved coordination and communication with other

governmental entities would improve my ability to contribute

Progress made improving coordination and communication within FDA

Improved coordination and communication within FDA

would improve my ability to contribute

Updated scientific technologies or other tools for the regulation of a diverse and 

expanding product base would improve my ability to contribute

Recruiting,

retaining, and

developing

a workforce

Modernizing

information

systems

Coordinating

internally

and

externally

Keeping

pace with

scientific

advances

Note: Percentages represent survey responses of a “great extent” and “very great extent.” In our 

survey, we did not ask managers about the extent to which improved communication with the public 

would improve their ability to contribute to meeting FDA’s goals and responsibilities, so this figure 

does not make that comparison. In the results, a higher percentage of managers indicated “no basis 

to judge/not applicable” for the questions asking about “Progress made improving coordination and 

communication with other federal agencies,” and “Progress made keeping pace with scientific 

advances necessary to regulate a diverse and expanding product base.” See the full results in our 

accompanying e-supplement for more information. All percentage estimates in this figure have a 

margin of error of plus or minus 10 percentage points or less. 

FDA has reported various efforts to recruit, retain, and develop a 

workforce, such as implementing a hiring surge, creating a fellowship 

program, and drafting an agency succession plan. As it relates to hiring, 

after receiving an increase in appropriations in fiscal year 2008, FDA 

Recruiting, Retaining, and 

Developing a Workforce 

Page 11 GAO-10-279 FDA's Planning and Management
 

embarked on a hiring surge to fill critical positions, such as medical 

officers, pharmacists, and consumer safety officers. FDA officials reported 

that the agency has hired more than 2,500 employees in fiscal years 2008 

and 2009. Officials also reported that the agency has exceeded its overall 

fiscal year 2009 hiring targets, and that most of its centers and offices met 

or exceeded their individual hiring targets in fiscal year 2009. One manager 

noted in our survey that increased funding in fiscal years 2008 and 2009 

allowed FDA to fill positions that had been vacant for more than 3 years. 

In addition, FDA has reported efforts to improve training and professional 

development. For example, in 2008, FDA created a fellowship program to 

attract scientists to work with mentors in different areas of regulatory 

science. Additionally, within the centers and offices, various efforts are 

under way. For example, CDRH and the Center for Veterinary Medicine 

(CVM) reported that they have initiated a variety of new training programs. 

The Center for Food Safety and Applied Nutrition (CFSAN) has developed 

a scientific seminar program, and the Center for Drug Evaluation and 

Research (CDER), among other things, is developing courses on 

management and communication. Lastly, in September 2009, FDA 

completed a succession plan identifying anticipated leadership gaps and 

workforce needs over the next several years. 

While FDA has reported efforts to address the challenge of recruiting, 

retaining, and developing a workforce, in our 2009 survey, fewer than onehalf of FDA managers reported that FDA was making great progress in this 

area.19 Specifically, while 80 percent of the managers in our survey 

reported that additional staff with needed knowledge, skills, and abilities 

would greatly improve their ability to contribute to FDA’s goals and 

responsibilities, only 43 percent stated that FDA was making great 

progress recruiting, retaining, and developing its workforce. Furthermore, 

when asked to identify their top priorities that FDA leadership should 

address to achieve its goals and responsibilities, FDA managers most 

commonly identified issues related to human capital management. 

In addition, FDA is not strategically managing its efforts in this area. 

Specifically, 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 

 

19Reported survey responses are estimates. Throughout this report, when we refer to 

managers reporting to a “great extent” on our 2009 survey of FDA managers, we also 

include managers responding to a “very great extent.” (See app. I for more details.) 

Page 12 GAO-10-279 FDA's Planning and Management
 

these efforts and guide its overall human capital management. In our 

previous work, we have reported that a strategic approach to marshaling, 

managing, and maintaining human capital is needed to maximize 

performance and ensure accountability, and that strategic human capital 

planning is critical to ensuring that agencies have the talent and skill mix 

they need to address their current and emerging human capital 

challenges.20 During meetings with FDA officials, we learned of some 

human capital planning efforts taking place in its centers and offices. For 

example, CVM has created its own succession plan, and ORA officials told 

us that in Fall 2008 they completed a workforce analysis to identify 

available expertise and gaps in each program area. However, in 2007, an 

HHS review found that FDA lacked an overarching systemic approach for 

assessing and improving human capital planning. Since then, FDA has not 

created an agencywide strategic human capital plan to do this.21 FDA has 

recently issued an agencywide succession plan, which covers plans to 

address anticipated needs in leadership positions, but the agency has not 

updated its 2006 workforce plan—a means to identify and address gaps 

between all current and future workforce needs—which has been out of 

date for 2 years. Without an updated workforce plan, FDA is lacking an 

important tool to help systematically determine its staffing needs, for 

example, which could have helped guide the large hiring efforts of the last 

2 years. FDA officials said that one reason the agency has had difficulty in 

its human capital planning is that the agency lost a great deal of its 

expertise in this area when HHS assumed human resources processing 

functions for the whole department, including FDA. In December 2009, 

FDA officials told us that they had recently initiated an agencywide effort 

to develop a strategic human capital plan and an updated workforce plan. 

FDA has reported taking efforts toward modernizing its IT and information 

management, such as launching new modernization projects, designing 

policies for investment and project management, and laying the 

Modernizing Information 

Systems 

 

20GAO, High-Risk Series: Strategic Human Capital Management, GAO-03-120

(Washington, D.C.: January 2003); and Human Capital: Sustained Attention to Strategic 

Human Capital Management Needed, GAO-09-632T (Washington, D.C.: Apr. 22, 2009). 

21On its Web site, the Office of Personnel Management notes that a strategic human capital 

plan should include the following: a clearly understood strategic direction; customer and 

stakeholder human capital management goals; strategies for accomplishing those goals; an 

implementation plan; a communication plan, if needed; and an accountability system. See 

the following Web address: 

http://www.opm.gov/HCAAF_RESOURCE_CENTER/RESOURCES.ASP (accessed on 

12/14/09). 

Page 13 GAO-10-279 FDA's Planning and Management
 

foundation for improved data systems. In June 2009, we reported that FDA 

had embarked on a number of relatively new modernization projects and 

had made some progress to establish important IT management 

capabilities.22 Specifically, we reported that FDA had established 

investment and project management policies and, according to an 

inspector general assessment, was making progress in addressing 

information security. Similarly, in August 2009, the FDA Science Board 

reported that FDA had made excellent progress in designing a new IT 

infrastructure, and that the agency was well-positioned to execute its new 

IT plans. 

While FDA has reported efforts to modernize its IT systems, survey 

responses from FDA managers and the August 2009 report from the FDA 

Science Board show that progress is still uneven. In our 2009 survey, 79 

percent of FDA managers reported that improving FDA’s IT and 

information management would greatly improve their ability to contribute 

to FDA’s goals and responsibilities, but only 39 percent reported that FDA 

was making great progress in this area. Furthermore, when we asked FDA 

managers in our survey to identify the top priorities that FDA leadership 

should address, improving IT was the third most commonly identified 

issue. For example, managers providing detailed written responses in our 

survey noted a lack of direction, focus, and strategic goals for IT at FDA 

and reported that some FDA systems were ineffective at sharing or 

reliably reporting data. In addition, the FDA Science Board recently found 

that FDA faces challenges to modernizing its IT capabilities.23 In its 2009 

report, the Science Board noted that FDA faces several challenges in 

implementing its new IT systems, including a shortage of expertise in 

health care data standards and a disconnect between FDA governance and 

IT execution teams. Additionally, the Science Board concluded that 

without a detailed IT adoption plan, it was difficult to assess the progress 

that FDA had made. 

Like the Science Board, our June 2009 report on FDA’s IT also identified 

weaknesses in FDA’s IT management. Specifically, we reported that 

significant work remained with regard to building enterprise 

architecture—that is, the modernization blueprints that describe FDA’s 

 

22GAO, Information Technology: FDA Needs to Establish Key Plans and Processes for 

Guiding Systems Modernization Efforts, GAO-09-523 (Washington, D.C.: June 2, 2009). 

23FDA Science Board, Subcommittee Review of Information Technology (Rockville, Md.: 

August 2009). 

Page 14 GAO-10-279 FDA's Planning and Management
 

operation in terms of business and technology. We also reported that the 

agency was not strategically managing IT human capital because it had not 

determined its IT skills needs or analyzed gaps between the skills of its 

workforce and the future needs of the agency.24 We concluded that 

without an effective enterprise architecture or strategic IT human

management, FDA has less assurance that it would be able to modernize 

effectively and have the appropriate IT staff to effectively implement and 

support its modernization efforts. We recommended that FDA 

expeditiously develop a comprehensive IT strategic plan, giving priority to 

architecture development, and complete key elements of IT human capital 

planning. In commenting on a draft of the June report, FDA agreed with 

our recommendations, and, in December 2009, officials told us that they 

were working to develop an IT strategic plan. 

 capital 

 

FDA has reported efforts to enhance coordination both within the agency 

and with other agencies and experts. However, in our survey, a minority of 

FDA managers reported that FDA was making great progress in addressing 

this challenge. For example, FDA reported that all of its centers and 

offices are in close contact with the agency’s offices located in India and 

China to share expertise and support. FDA also has reported that CDRH 

and ORA have teamed up to offer training on radiation safety and 

awareness to ORA imports officers. As it relates to external coordination, 

in March 2009, the President created the Food Safety Working Group 

(FSWG) to improve food safety and assess performance metrics. FDA 

participates in this group, along with the U.S. Department of Agriculture’s 

(USDA) Food Safety and Inspection Service (FSIS), the Centers for 

Disease Control and Prevention (CDC), and other federal agencies. In 

another example of external coordination, ORA reported that it is involved 

in collaborations with agencies, such as the Department of Defense and 

the Department of Homeland Security, in areas such as sharing 

information on food protection. Also, FDA told us that during the 2009 

foodborne illness outbreak linked to peanut products, FDA used an 

incident command structure to more effectively work with other federal 

agencies, state regulators, and industry members to identify the source of 

the outbreak. 

Coordinating Internally and 

Externally 

While these recent efforts are encouraging, a minority of FDA managers in 

our survey reported that FDA was making great progress in the area of 

coordination. Specifically, while 70 percent of FDA managers in our 

24GAO-09-523. 

Page 15 GAO-10-279 FDA's Planning and Management
 

survey reported that better internal coordination and communication 

would greatly improve their ability to contribute to FDA’s goals and 

responsibilities, only 28 percent reported that FDA was making great 

progress in this area. Furthermore, we asked FDA managers in our survey 

to identify the top priorities that FDA leadership should address to achieve 

agency goals and responsibilities, and the second most commonly 

identified issue was improving coordination within FDA. For example, in 

detailed written comments in our survey, some managers noted that 

agency leaders should consult with the centers more frequently to obtain 

input regarding performance, budgetary needs, and other administrative 

initiatives. Other managers noted that better coordination among FDA’s 

centers could increase effectiveness and decrease redundancy. As it 

relates to coordinating with other federal agencies, we found similar 

results: While 49 percent of FDA managers reported in our survey that 

better coordination and communication with other federal governmental 

entities would greatly improve their ability to contribute to FDA’s goals 

and responsibilities, only 19 percent of survey respondents reported that 

they believed the agency was making great progress in this area. 

FDA has reported efforts to keep pace with scientific advances, but a 

minority of FDA managers reported in our survey that the agency was 

making great progress. FDA has reported some efforts. For example, FDA 

reported that in May 2008, the agency created the Office of the Chief 

Scientist, and, in May 2009, added more responsibilities to the office to 

signal a new emphasis on regulatory science. FDA also told us they had 

plans to identify major scientific crosscutting opportunities across its 

centers and to collaborate with other government agencies, such as the 

National Institutes of Health, and with research universities. Additionally, 

according to FDA, NCTR is establishing two new research facilities to 

address emerging areas of science, such as nanotechnology. However, 

while 67 percent of FDA managers in our survey reported that updated 

scientific technologies or other tools would greatly help them to 

contribute to FDA’s goals and responsibilities, only 36 percent of 

managers reported that they believed FDA was making great progress in 

keeping pace with scientific advances. For example, in some written 

comments in our survey, some managers stressed the need for increasing 

funding, resources, and technology for science. 

Keeping Pace with Scientific 

Advances 

FDA also has reported undertaking efforts to improve its communication 

with the public, and a majority of FDA managers indicated in our survey 

that the agency was making great progress in this area. FDA reported that 

in September 2009, it released a strategic plan on risk communication that 

lays out the agency’s plans for disseminating information to the public and 

Communicating with the Public 

Page 16 GAO-10-279 FDA's Planning and Management
 

overseeing industry communications. Similarly, in June 2009, the agency 

reported that it had created a Transparency Task Force to help improve 

the availability and quality of public information. Additionally, during the 

2008-2009 foodborne illness outbreak related to peanut products, FDA 

used social media and internet tools, such as a blog hosted by CFSAN, to 

inform the public of product recalls. In our survey, FDA managers 

reported that communication was an area of improvement: Fifty-three 

percent of FDA managers in our survey reported that they believed FDA 

was making great progress in communicating product safety information 

to the public. For example, in their detailed written comments in our 

survey, some managers noted that FDA was receiving positive comments 

on the amount and timeliness of information provided to the public 

through the agency’s new Web site design. These efforts to increase 

transparency and reach out to the public hold promise, but it is too soon to 

tell their long-term effect in improving public communication. 

FDA’s 48 annual performance measures for fiscal year 2010 are only 

partially results-oriented because they do not adhere to some key 

characteristics we identified from our work on government performance 

issues that could help decision makers effectively gauge agency progress. 

Of these characteristics, FDA generally incorporated some characteristics 

into its fiscal year 2010 performance measures—that is, FDA linked its 

measures to agency and department goals, showed baseline and trend data 

for past performance, included explanatory information, and included 

intermediate measures to show progress toward longer term goals. 

However, FDA’s measures do not incorporate other characteristics we 

identified. Specifically, FDA’s measures do not focus on public health 

outcomes, address important dimensions of the agency’s performance, 

identify projected target levels of performance for multiyear goals, or fully 

address identified management challenges. Without such characteristics, 

FDA is missing opportunities to guide decisions and assess actual 

performance. 

FDA’s Annual 

Performance 

Measures Are Only 

Partially ResultsOriented 

FDA’s Performance 

Measures Incorporate 

Some Key Characteristics 

to Improve Their 

Usefulness to Decision 

Makers 

FDA has incorporated some selected characteristics of results-oriented 

performance measures that can improve the usefulness of such measures 

to decision makers. In our review of the fiscal year 2010 budget request for 

FDA, we found that the agency incorporated the following characteristics 

in its performance measures: 

Page 17 GAO-10-279 FDA's Planning and Management
 

• A linkage to agency and department goals, which can help clarify the 

relationship between yearly measures and longer term goals and 

objectives. Specifically, FDA linked each of its 48 annual performance 

measures to 1 of the agency’s 14 objectives, which in turn link to FDA’s 

and HHS’s strategic goals. For example, FDA linked 1 of its measures—the 

number of high-risk animal drug and feed inspections—with the agency’s 

strategic goal on oversight of manufactured products. 

• Inclusion of explanatory information on each of its performance 

measures, which can help provide a rationale for the measure or inform 

readers of data sources. For example, in its explanatory notes on its 

performance measure to increase laboratory capacity in the event of a 

terrorist attack on the food supply, FDA noted that it gains this increased 

capacity by awarding cooperative agreements to states with applicable 

chemistry and radiological laboratories, which receive funding for training 

and testing. 

• Showing baseline and trend data for each of its performance measures, 

which can help decision makers draw conclusions about whether the 

performance measures are reasonable and appropriate. Our review of the 

fiscal year 2010 budget request found that it generally lists up to 5 years of 

baseline and trend data for the agency’s performance measures, except for 

newer measures where trend data are not yet available. 

• Using intermediate performance measures, which can help show progress 

toward intended results. For instance, when it may take years before an 

agency sees the results of its programs, intermediate measures can 

provide information on interim results. For example, one of FDA’s 

performance measures is to develop risk assessment methods and build 

biological dose-response models in support of food protection. In fiscal 

year 2008, the target for this measure was to develop tests that could 

determine the presence of the toxin ricin. In fiscal year 2010, the target 

was to develop rapid-detection toolkits for foodborne pathogens, 

applicable to fresh produce and usable in the field. 

FDA’s Performance 

Measures Lack Other Key 

Characteristics of ResultsOriented Measures 

FDA’s fiscal year 2010 performance measures lack other selected 

characteristics of results-oriented measures. First, most of FDA’s 

performance measures do not focus on outcomes. Instead, 38 of FDA’s 48 

performance measures are output measures—which provide information 

on products or services delivered—or efficiency measures—which provide 

information on the relationship between the agency’s outputs and the 

resources used to produce them. Only 10 are outcome measures that 

provide information on the actual public health results of FDA’s work that 

Page 18 GAO-10-279 FDA's Planning and Management
 

are of interest to the public. Table 2 provides information on the number 

and type of FDA’s 48 performance measures for fiscal year 2010 by center 

and office. Specifically, when examining these performance measures 

across FDA’s centers and offices, we found that none of the annual 

performance measures for five centers and offices—the Center for 

Biologics Evaluation and Research (CBER), CDER, CVM, NCTR, and the 

Office of the Commissioner (OC)—are outcome measures. For example, 

both of CVM’s annual performance measures are outputs that tally the 

number of new animal drug applications the center reviewed. While 

reviewing new drug applications is an important part of CVM’s work, these 

tallies do not provide information on the extent to which the center has 

accomplished the broader public health goals that those reviews of drug 

applications are intended to achieve. Only two centers—CDRH and 

CFSAN—focus more heavily on outcomes: All of CDRH’s five measures 

and two of CFSAN’s three measures are outcome measures. For example, 

one of CDRH’s outcome measures tracks the percentage of domestic 

mammography facilities that meet certain inspection standards.25 In our 

survey of FDA managers, several respondents provided detailed written 

comments indicating a need for more outcome measures. For example, 

one manager commented that there was a great need for agency goals to 

go beyond providing tallies and information on tasks completed. Another 

manager suggested that FDA establish long-term goals and outcome 

measures that reflect agency priorities. 

Table 2: Number of FDA’s Fiscal Year 2010 Performance Measures, by Center and 

Office 

Center/Office

Output and efficiency 

measures

Outcome 

measures

Total 

measures

CBER 6 0 6

CDER 8 0 8

CDRH 0 5 5

CFSAN 1 2 3

CVM 2 0 2

NCTR 6 0 6

 

25This measure’s target for fiscal years 2007 through 2010 is for 97 percent of facilities to 

meet those standards, and FDA reports meeting that target for all years in which data are 

available. 

Page 19 GAO-10-279 FDA's Planning and Management
 

Center/Office

Output and efficiency 

measures

Outcome 

measures

Total 

measures

OC 3 0 3

ORA 12 3 15

Total 38 10 48

Source: GAO analysis of FDA data. 

FDA’s 2010 performance measures also do not address important 

dimensions of the agency’s performance, such as addressing all major 

strategic objectives, which is another key characteristic of results-oriented 

measures. The performance measures listed in the fiscal year 2010 budget 

request do not fully address many of FDA’s main strategic objectives. (See 

app. II for a crosswalk of FDA’s strategic goals and objectives to fiscal 

year 2010 performance measures.) Specifically, of the 14 objectives in 

FDA’s 2007 Strategic Action Plan, 5 do not have associated performance 

measures. FDA’s performance measures are clustered under 2 of FDA’s 4 

strategic goals related to increasing access to new medical and food 

products and improving the quality and safety of manufactured products 

and the supply chain. 

In addition to not focusing on outcomes and to omitting important 

dimensions of agency performance, FDA’s performance measures also do 

not provide projected target levels of performance beyond the immediate 

budget year for its multiyear goals—another characteristic of resultsoriented measures. Where appropriate, an agency should convey what it 

expects to achieve in the long term by including multiyear performance 

goals. FDA’s lack of such measures deprives stakeholders of an indication 

of the longer term progress the agency expects to make. 

Finally, FDA’s annual performance measures for fiscal year 2010 do not 

address some mission-critical management challenges. Our review of the 

fiscal year 2010 budget request for FDA found that the agency does not 

have measures related to its management challenges to recruit, retain, and 

develop its workforce or to communicate safety information to the public. 

In addition, its performance measures for 2010 only partially address the 

management challenge of coordinating internally and externally. For 

example, we found several performance measures relating to coordinating 

internally and externally, but none of them specifically measure 

performance to improve FDA’s internal coordination. 

Without results-oriented performance measures, FDA has less information 

available to effectively measure the agency’s progress toward meeting its 

Page 20 GAO-10-279 FDA's Planning and Management
 

intended goals. In past work, we have acknowledged that such measures 

are sometimes difficult to develop.26 For example, we have reported that 

federal managers face challenges developing outcome measures when a 

program or line of effort was not easily quantifiable, and that it can be 

difficult to distinguish the impact of a particular federal program from the 

impact of other programs and factors, thus making it difficult to attribute 

specific program performance to results. Despite these difficulties, FDA 

officials acknowledged that they need more representative, outcomeoriented measures, and they said that the agency is working to develop 

them. Specifically, officials told us that the agency hopes to create 

between one and three performance measures for each of its objectives 

that will focus more on public-health-related outcomes. For example, 

officials from CFSAN noted that they are trying to create an outcome 

measure related to shortening the amount of time it takes the agency to 

accurately identify pathogens associated with a foodborne illness 

outbreak. FDA officials told us that some of these changes may be 

reflected in the agency’s fiscal year 2011 and future year budget requests. 

FDA has taken steps across the agency to align its activities and resources 

to the strategic goals in its Strategic Action Plan, but has not clearly 

demonstrated alignment at the center and office level. In our previous 

work, we have noted that sound planning is not enough to ensure success, 

and that an organization’s activities and resources must be aligned to help 

it achieve its goals and mission.27 In developing its Strategic Action Plan, 

FDA aligned the three areas of regulatory activities that are central to the 

agency’s mission—pre-market review, production oversight, and postmarket surveillance—to three of the agency’s four strategic goals in its 

plan: 

• Pre-market review covers FDA’s activities to approve, or clear for 

marketing, new medical products and develop regulations or guidance for 

food and medical product safety, among other things. In its Strategic 

Action Plan, FDA aligned these activities with its strategic goal to increase 

access to new medical and food products. 

Although Some 

Progress Has Been 

Made, Alignment of 

Activities and 

Resources to 

Strategic Goals Is 

Unclear at the Center 

and Office Level 

• Production oversight covers FDA’s activities related to inspections of 

food and medical product facilities, import entry review, investigations 

 

26GAO-04-38. 

27GAO/GGD-96-118. 

Page 21 GAO-10-279 FDA's Planning and Management
 

and recalls, and enforcement activities, among other things. In its Strategic 

Action Plan, FDA aligned these activities with its strategic goal to improve 

the quality and safety of manufactured products and the supply chain. 

• Post-market surveillance covers FDA’s activities related to surveillance of 

products that FDA has approved or cleared for marketing, including 

adverse event report processing, advertising oversight, and risk 

communication research. In its Strategic Action Plan, FDA aligned these 

activities with its strategic goal to improve patient and consumer safety. 

FDA has placed a variety of other activities under its strategic goal to 

strengthen FDA for today and tomorrow, including policy development, 

administration and systems, and external relations, among others. In 

aligning its strategic goals to these activities, FDA intends to provide 

continuity across the wide range of activities taking place across its 

centers and offices, each of which has a unique organizational structure 

and scope of responsibility. 

In addition to aligning its main activities to goals in the Strategic Action 

Plan, FDA also uses employee performance plans to help ensure that its 

employees’ activities are linked to the agency’s strategic goals. 

Performance plans for FDA employees, including senior executives, 

describe an individual’s responsibilities for the year, and HHS specifies 

that for all HHS managers and employees, elements in those plans must 

link to HHS or FDA goals. For example, one FDA senior executive’s fiscal 

year 2008 performance plan we reviewed included a responsibility to 

identify a certain number of candidates for FDA’s fellowship program. 

This responsibility was explicitly linked to FDA’s strategic goals in premarket review and post-market surveillance in that manager’s 

performance plan. We previously reported that such linkages help create a 

“line of sight” between individual performance and organizational 

success,28 and FDA officials told us that this practice is improving 

employees’ understanding of their work in the larger context of the 

agency. 

While FDA has taken steps through its Strategic Action Plan and individual 

performance plans to align activities with goals across the agency, FDA 

has not clearly demonstrated alignment of activities to goals within its 

centers and offices. Currently, only four of FDA’s eight centers and offices 

 

28GAO-04-38. 

Page 22 GAO-10-279 FDA's Planning and Management
 

we reviewed clearly demonstrated that their activities aligned to FDA’s 

goals through their documentation. Each of FDA’s main centers and 

offices has its own focus and responsibilities and conducts activities to 

meet those responsibilities in a variety of ways. Therefore, it is important 

for FDA to link these activities to FDA’s overall goals to ensure 

agencywide alignment. While officials told us that their activities are 

generally linked to goals, they also noted that those links are not always 

clear. Furthermore, our review of documentation on FDA’s program 

activities showed that only four of the eight centers and offices we 

reviewed—CDER, CDRH, CVM, and NCTR—provided clear links between 

their activities and FDA’s goals that can help congressional decision 

makers understand how the agency intends to accomplish its goals. 

Specifically, part of CDER, CDRH, and CVM’s main program activities in 

the fiscal year 2010 budget request for FDA included the areas of premarket review and post-market surveillance, which correspond to 2 of 

FDA’s strategic goals. Similarly, NCTR used its strategic plan to explicitly 

link its main activities, including personalized nutrition and medicine and 

food protection, to FDA’s goals. 

In contrast to CDER, CDRH, CVM, and NCTR, the other four centers and 

offices we reviewed—CBER, CFSAN, OC, and ORA—did not clearly 

demonstrate alignment of their program activities to FDA’s goals through 

their documentation. For example, the fiscal year 2010 budget request for 

FDA noted that CFSAN’s activities fall into four areas—ensuring food 

protection, improving nutrition, improving dietary supplement safety, and 

improving cosmetic safety—and did not explain the relationship between 

these four areas and FDA’s goals. FDA officials told us that CFSAN’s 

activities were guided by FDA’s 2007 Food Protection Plan and, more 

recently, the administration’s newly formed FSWG, and that both are 

similar to FDA’s Strategic Action Plan in their organization around premarket review, production oversight, and post-market surveillance. 

However, neither the Food Protection Plan nor FSWG covers CFSAN’s 

responsibilities related to nutrition, dietary supplements, and cosmetics. 

The relationship between FDA’s activities and its goals was more clear in 

the past. Specifically, the fiscal year 2008 budget request for FDA did 

include some information on the relationship between each center’s and 

office’s program activities and FDA’s strategic goals, but officials told us 

that this information was not included in the budget request in fiscal years 

2009 and 2010 to make the document more concise. While a concise 

presentation is important, the lack of clear alignment between activities 

and goals hinders Congress’s ability to assess the likelihood of FDA’s 

success. FDA officials told us that the agency is working to implement a 

new performance management system that will improve transparency, 

Page 23 GAO-10-279 FDA's Planning and Management
 

accountability, and alignment of activities to goals, and is piloting the new 

system in offices across the agency. 

FDA has worked to align its resources to its strategic goals by assigning 

dollar amounts of requested resources to many of its performance 

measures. We reported that accurately depicting how funding is allocated 

to achieve goals is a critical step in defining the performance 

consequences of budgetary decisions.29 To provide information to 

Congress on the resources needed to achieve intended results, agencies—

following OMB30 guidance—should link the resources requested for each 

program to expected levels of performance, and, at a minimum, resources 

should be aligned at the program level and, if possible, to an agency’s 

annual performance measures.31 FDA has assigned dollar amounts to each 

of its performance measures in the fiscal years 2009 and 2010 budget 

requests for FDA. Specifically, in fiscal year 2010, FDA has assigned about 

$3.1 billion of its total requested budget of about $3.2 billion to many of its 

performance measures in the budget request. For example, in that request, 

FDA assigned an amount of $341 million to its performance measure on 

high-risk food inspections and $224 million to its performance measure on 

establishing and maintaining accreditation for ORA laboratories. 

However, clear linkages between FDA’s resources and its goals are still 

incomplete. First, as we have previously noted in our discussion of FDA’s 

performance measures, not all important dimensions of FDA’s 

performance are addressed by the agency’s fiscal year 2010 measures. 

FDA officials have told us that the dollar amounts assigned to 

performance measures in the budget are incomplete because some of 

FDA’s work is related to efforts not covered by its current set of 

performance measures. Officials also told us that they are working to 

revise the budget request to provide greater transparency in how FDA 

allocates resources by performance goals. 

 

29GAO, Performance Budgeting: Initial Experiences Under the Results Act in Linking 

Plans with Budgets, GAO/AIMD/GGD-99-67 (Washington, D.C.: Apr. 12, 1999). 

30OMB is responsible for receiving and reviewing agencies’ strategic plans, annual 

performance plans, and annual performance reports. To improve the quality and 

consistency of the documents, OMB issues annual guidance to agencies for their 

preparation, including guidelines on format, required elements, and submission deadlines. 

31OMB Cir. No. A-11, Sec. 220, p. 1 (2009). 

Page 24 GAO-10-279 FDA's Planning and Management
 

In addition, with the exception of NCTR and CVM, officials from FDA’s 

centers and offices told us that they do not track workload—as measured 

through the agency’s various employee time reporting systems—by 

strategic goals, which hinders FDA’s and Congress’s ability to effectively 

understand the link between such costs and outcomes. Specifically, while 

more than one-half of FDA’s budgetary obligations relates to personnel 

costs, only two of the centers and offices we reviewed—NCTR and CVM—

have established a means, through their employee time reporting systems, 

to allow effective tracking of employees’ work back to FDA’s strategic 

goals. NCTR tracks employee’s time according to each of its research 

projects. Projects each then link to the center’s and agency’s strategic 

goals. In addition, CVM has a time reporting system that tracks 100 percent 

of its employees’ work time to specific activities, which map to FDA’s 

goals. While the other centers and ORA track employees’ work time to 

varying degrees, which can provide useful management information, 

officials told us that they do not track that time to FDA’s goals, which 

limits management’s ability to understand how employees’ time, and 

therefore the bulk of FDA’s resources, is used in support of FDA’s goals. 

We have recently reported similar limitations in FDA’s tracking of 

resources in other areas. In our 2008 review of FDA’s oversight of fresh 

produce safety, we reported that FDA has not consistently and reliably 

tracked its spending on oversight of fresh produce.32 Furthermore, in our 

2009 review of the resources supporting FDA’s medical product oversight, 

we reported that FDA could not provide data showing its workload and 

accomplishments in some areas, depriving the agency of basic data needed 

for managing its programs.33 To address this problem, we recommended 

that FDA take steps to establish a comprehensive and reliable basis for 

substantiating the agency’s resource needs. FDA agreed with our 

recommendations and told us in December 2009 that they awarded a 

contract to help them estimate the resources needed to fulfill their 

responsibilities, which could, among other things, help FDA better link 

their resources to agency goals. The current lack of clear linkages between 

FDA’s resources and its goals limits the ability of congressional decision 

makers to understand how spending is affecting outcomes and whether 

 

32GAO-08-1047. 

33GAO, Food and Drug Administration: FDA Faces Challenges Meeting Its Growing 

Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource 

Needs, GAO-09-581 (Washington, D.C.: June 19, 2009). 

Page 25 GAO-10-279 FDA's Planning and Management
 

the agency should be allocating its resources differently to be more 

effective at achieving its regulatory mission. 

In our 2009 survey, about one-third to one-half of FDA managers reported 

using performance information to a great extent to make management 

decisions, with the extent varying depending on the type of management 

decision. These results did not differ significantly from our 2007 survey 

results for all federal managers, when we concluded that more progress 

was needed for agencies to further integrate information about program 

performance into their decision making. When we surveyed agency 

managers on practices to improve the use of performance information, 

one-half or fewer of FDA managers reported extensive application of 

practices, such as demonstrating management commitment, to encourage 

the use of performance information, or reported having had training in the 

use of performance information. 

About One-half or 

Fewer FDA Managers 

in Our Survey 

Reported Extensive 

Use of Performance 

Information and 

Application of 

Practices to 

Encourage Its Use 

About One-third to Onehalf of FDA Managers 

Reported Using 

Performance Information 

Extensively, Depending on 

the Type of Management 

Decision 

In our 2009 survey, about one-third to one-half of FDA managers reported 

using performance information to a great extent for making selected 

management decisions, with the extent depending on the particular type of 

management decision.34 As we have observed in our prior work, agencies 

fully realize the benefit of collecting and measuring performance 

information only when this information is used to support management 

planning and decision making.35 FDA managers answered seven questions 

in our survey related to the extent of their use of performance information 

to make selected management decisions, and, depending on the question, 

33 percent to 53 percent of FDA managers reported great use of 

performance information to make particular types of decisions.36 (See fig. 

3.) For example, 47 percent of FDA managers reported in our survey that 

 

34Reported survey responses are estimates. Throughout this report, when we refer to 

managers reporting a “great extent” on our 2009 survey of FDA managers, we are also 

including managers responding “very great extent.” (See app. I for more details.) 

35GAO-05-927. 

36In our prior work, we identified the following four types of management decisions for 

which federal managers can use performance information to improve programs and 

results: (1) identifying problems and taking corrective action; (2) developing strategy and 

allocating resources; (3) recognizing and rewarding performance; and (4) identifying and 

sharing effective approaches. We reviewed seven questions in our survey related to these 

four types of management decisions. 

Page 26 GAO-10-279 FDA's Planning and Management
 

they used performance information to a great extent when identifying 

program problems to be addressed. The percentage of FDA managers 

reporting extensive use of performance information did not differ 

significantly from the percentage of all federal managers answering the 

same questions in our 2007 survey. In our testimony on that 2007 survey, 

we concluded that progress was still needed for agencies to further 

integrate information about program performance into their decision 

making.37

Figure 3: Percentage of FDA Managers Reporting Great Use of Performance Information for Selected Management Decisions 

0 20 40 60 80 100

Identifying and sharing effective program approaches with others

Rewarding government employees I manage or supervise

Allocating resources

Setting program priorities

Developing program strategy

Taking corrective action to solve program problems

Identifying program problems to be addressed

Estimated percentage

47

48

40

49

47

53

33

Source: GAO.

Note: Percentages represent survey responses of a “great extent” and “very great extent.” All 

percentage estimates in this figure have a margin of error of plus or minus 10 percentage points or 

less. 

In responding to our 2009 survey, FDA managers provided detailed written 

examples of how they used performance information to make 

management decisions. For example, FDA managers told us that they used 

 

37GAO-08-1026T. 

Page 27 GAO-10-279 FDA's Planning and Management
 

• data on progress toward goals to identify program areas in need of closer 

inspection; 

• information on the quality, productivity, and relevance of research output 

to allocate research resources; 

• employee performance information to grant awards, bonuses, and 

promotions; and 

• productivity reports from specific programs to identify effective program 

approaches to implement FDA’s hiring initiative in 2008 and 2009 and 

share them within and outside the agency. 

Less than One-half of FDA 

Managers Reported 

Extensive Application of 

Practices or Having 

Received Training to 

Encourage Use of 

Performance Information 

In our 2009 survey about one-quarter to one-half of FDA managers 

reported extensive application of practices, such as demonstrating 

management commitment, to encourage the use of performance 

information. FDA managers’ reported use of performance information was 

not significantly different from the results of our 2007 survey of all federal 

managers, when we reported that progress was still needed. Therefore, we 

reviewed FDA managers’ survey responses on agency use of practices to 

help make progress in this area. As we have previously reported, agencies 

can benefit from applying practices that can enhance the use of 

performance information for policy and program decisions aimed at 

improving results.38 In selected survey questions, about 27 percent to 47 

percent of FDA managers reported that these practices were applied to a 

great extent at FDA, depending on the practice. (See fig. 4.) For example, 

41 percent of FDA managers agreed to a great extent with the statement 

that FDA’s top leadership demonstrates a strong commitment to using 

performance information to guide decision making. These estimates are 

not significantly different from what we found in 2007 when we surveyed 

managers across the federal government on their application of practices 

to encourage the use of performance information. 

 

38See GAO-05-927. We focused on the following four practices: (1) demonstrating 

management commitment; (2) improving the usefulness of performance information to 

better meet management’s needs; (3) frequently and effectively communicating 

performance information within the agency; and (4) developing agency capacity to 

effectively use performance information. We did not use the survey to review one of our 

identified practices on aligning agencywide goals, objectives, and measures, because our 

second and third research objectives examined this topic using other research methods. 

Page 28 GAO-10-279 FDA's Planning and Management
 

Figure 4: Percentage of FDA Managers Reporting Extensive Application of Selected Practices to Encourage the Use of 

Performance Information 

Source: GAO.

0 10 20 30 40 50 60 70 80 90 100

FDA’s top leadership demonstrates a strong commitment

to using performance information to guide decision making

FDA managers/supervisors at my level take steps to ensure

 that performance information is useful and/or appropriate

FDA managers/supervisors at my level effectively

communicate performance information on a routine basis

FDA is investing in resources to improve

 its capacity to use performance information

27

46

47

41

Estimated percentage

Note: Percentages represent survey responses of a “great extent” and “very great extent.” All 

percentage estimates in this figure have a margin of error of plus or minus 10 percentage points or 

less. 

One way to develop agency capacity to use performance information is 

through training, but fewer than one-half of FDA managers reported 

receiving such training. Our review of responses to our 2009 survey 

questions related to developing agency capacity to use performance 

information shows about one-third of FDA managers reported receiving 

three types of training related to performance information and slightly 

more reported receiving three other types. (See fig. 5.) For example, 34 

percent of FDA managers reported in 2009 that they had received training 

in using performance information to make decisions. FDA’s weakness in 

this area hinders its ability to build capacity and ensure that performance 

information is easily collected, communicated, and analyzed. 

Page 29 GAO-10-279 FDA's Planning and Management
 

Figure 5: Percentage of FDA Managers Reporting That They Received Six Types of Training Related to Performance 

Information 

0 10 20 30 40 50 60 70 80 90 100

Conduct strategic planning

Link the performance of program(s)/operation(s)/

project(s) to the achievement of FDA's strategic goals

Use program performance information to make decisions

Assess the quality of performance data

Develop program performance measures

Set program performance goals 46

43

32

34

36

41

Source: GAO.

Estimated percentage

Note: All percentage estimates in this figure have a margin of error of plus or minus 10 percentage 

points or less. 

Training is important because, as we have noted in prior work, managers 

must understand how the performance information they gather can be 

used to provide insight into the factors that impede or contribute to 

program successes; assess the effect of the program; or help explain the 

linkages between program inputs, activities, outputs, and outcomes.39 In 

earlier work, we found a positive relationship between agencies providing 

training on setting program performance goals and the use of performance 

information when setting or revising them.40 In that work, we 

recommended that OMB work with agencies to ensure that they were 

making adequate investments in training on performance planning and 

measurement, with a particular emphasis on how to use performance 

information to improve program performance. OMB has not acted on this 

recommendation. FDA officials told us in December 2009 that they are in 

the planning stages of developing performance budget training, which will 

 

39GAO-08-1026T. 

40GAO-04-38. 

Page 30 GAO-10-279 FDA's Planning and Management
 

include a module on performance measure development suitable for

program managers, but the agency does not have a timeline for this 

training. 

ic 

ct 

te 

ce for 

nder 

ce 

s 

rvey 

d thus FDA—make improvements in the overall use of 

such information. 

Conclusions Along with concerns expressed by others, our work examining strateg

planning and management at FDA indicates that the agency is facing 

significant management challenges that could affect its ability to prote

Americans from unsafe and ineffective products. FDA is aware of its 

challenges and has taken steps to address them, but the agency still does

not fully use practices for effective strategic planning and management. 

Notably, FDA’s lack of a strategic human capital plan and an up-to-da

workforce plan limits the agency’s ability to effectively recruit, hire, 

manage, and maintain the highly skilled workforce it needs to skillfully

execute its mission. In addition, FDA’s performance measures do not

include some key characteristics we reviewed that can help provide 

decision makers with useful information on agency results. Specifically, 

FDA’s measures do not focus on outcomes, address important dimensions 

of agency performance, identify projected target levels of performan

multiyear goals, or fully address identified management challenges.

Without these characteristics, FDA may not be collecting all of the 

information it needs to make good decisions on the best strategies and 

resources to employ to fulfill its mission. Furthermore, four of the eight 

centers and offices we reviewed did not clearly demonstrate alignment of 

program activities to goals through their documentation, which can hi

congressional decision makers’ ability to understand how the agency 

intends to accomplish its goals. Similarly, linkages between resources and 

goals at FDA are incomplete for two reasons: Not all important dimensions 

of FDA’s performance are addressed by the agency’s existing performan

measures, and several of FDA’s centers and offices do not clearly track 

their workload according to strategic goals. The absence of such linkage

hinders FDA’s and congressional decision makers’ ability to effectively 

understand the link between costs and outcomes. Finally, our 2009 su

shows that fewer than one-half of FDA managers reported receiving 

training on the use of performance information. Such training could help 

FDA managers—an

Page 31 GAO-10-279 FDA's Planning and Management
 

To help the agency more strategically manage its operations, we are 

making five recommendations to the Commissioner of the Food and Drug 

Administration. 

• To more strategically manage its human capital, we recommend that the 

Commissioner of FDA develop a strategic human capital plan and issue an 

updated workforce plan. 

• To help decision makers more effectively gauge agency progress, we 

recommend that the Commissioner of FDA work to make FDA’s 

performance measures more results-oriented. 

• To more clearly demonstrate the alignment of activities to strategic goals, 

we recommend that the Commissioner of FDA 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- and 

office-level documents. 

• To more clearly demonstrate alignment of resources to strategic goals, 

once FDA creates a more results-oriented set of performance measures, 

we recommend that the Commissioner of FDA direct FDA’s centers and 

offices to track their workload by strategic goals. 

• To encourage greater use of performance information, we recommend that 

the Commissioner of FDA work to build FDA’s capacity to collect and 

analyze performance information by expanding training for managers on 

topics related to performance information. 

We provided a draft of this report to the Department of Health and Human 

Services for review, and HHS provided written comments, which are 

reprinted in appendix III. HHS noted that the Food and Drug 

Administration agreed with our recommendations and that FDA is in the 

process of implementing them. The department also noted that our report 

provides a baseline of past strategies and management practices against 

which FDA’s leadership can measure its progress. 

Recommendations for 

Executive Action 

Agency Comments 

and Our Evaluation 

HHS also provided us with additional information in its written comments 

related to FDA’s efforts to implement each of the recommendations we 

made in our draft report. Specifically, in regards to our recommendations 

that FDA: 

Page 32 GAO-10-279 FDA's Planning and Management
 

• Develop a strategic human capital plan and issue an updated workforce 

plan: HHS noted that FDA has recently awarded a contract to support 

development of these plans. 

• Make its performance measures more results-oriented: HHS stated that 

FDA is developing a new performance tracking and management system. 

The department also noted that FDA is working to improve and expand 

the performance measures to be included in the fiscal year 2011 budget 

request for FDA. 

• Clearly align its program activities to its strategic goals: HHS indicated 

that FDA will include a new table in the fiscal year 2011 budget request 

that links each subprogram area to FDA’s strategic objectives. 

• Track workload by strategic goals: HHS noted that FDA has awarded a 

contract to help develop its ability to estimate its resource needs. The 

department stated that the workload models produced by this project will 

serve as a foundation for further efforts to link workload to the agency’s 

goals. 

• Expand training on topics related to performance information: HHS 

noted that FDA is developing a training plan and a Statement of Work 

related to this issue. The department stated that FDA plans to develop or 

purchase training modules and pilot them in fiscal year 2010, with the 

training expected to be made available in fiscal year 2011. 

In its written comments, HHS also noted that language in our draft report 

comparing our 2009 survey results on training related to performance 

information with similar results in our 2007 governmentwide survey was 

not valid because the response options for the two surveys differed. We 

agree and have removed that comparison from our final report. However, 

because training can increase the use of performance information and 

fewer than one-half of FDA managers reported receiving it, our conclusion 

remains unchanged—that training is needed to improve FDA managers’ 

capacity to use performance information. FDA agreed with the resulting 

recommendation. 

HHS also provided us with technical comments, which we incorporated as 

appropriate. 

Page 33 GAO-10-279 FDA's Planning and Management
 

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the appropriate 

congressional committees, the Commissioner of the Food and Drug 

Administration, and other interested parties. The report also will be 

available at no charge on the GAO Web site at http://www.gao.gov. 

If you or your staffs have any questions about this report, please contact 

Lisa Shames at (202) 512-3841 or shamesl@gao.gov or Marcia Crosse at 

(202) 512-7114 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this report. GAO staff who made key contributions to this report are 

Lisa Shames 

listed in appendix IV. 

ronment 

Marcia Crosse 

Director, Health Care 

Director, Natural Resources and Envi

Page 34 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

Page 35 GAO-10-279 

Appendix I: Objectives, Scope, and 

Methodology 

In this report, we examined the extent to which (1) the Food and Drug 

Administration’s (FDA) 2007 Strategic Action Plan1

 contains strategies to 

address its management challenges, and the progress FDA has reported in 

addressing those challenges; (2) FDA’s annual performance measures are 

results-oriented; (3) FDA has aligned its activities and resources to 

support its strategic goals; and (4) FDA managers reported using 

performance information in decision making and applying key practices to 

encourage that use. To address part of our work for our first and fourth 

objectives, we administered a Web-based survey on performance and 

management issues to a sample of managers at FDA from June through 

August, 2009. For the purposes of this report, we defined managers and 

supervisors as those employees at or above the GS-13 level as indicated in 

FDA’s data submissions to the Office of Personnel Management (OPM), or 

those of equivalent rank in other pay systems, including Public Health 

Service Commissioned Corps Officers. When we use the term “managers,” 

we refer to both managers and supervisors. The sample was a stratified, 

random, probability sample of 437 persons from a population of 1,276 FDA 

managers, drawn from data provided by the agency in May 2009. Over 300 

respondents, or about 70 percent of our sample, completed the 

questionnaire, as indicated by the respondent. The Web-based survey 

included a final question asking respondents if they were ready to submit 

their final and official responses to GAO. We did not use survey responses 

in our analysis unless respondents indicated that their survey was 

complete. The response rate across the eight FDA centers and offices we 

surveyed ranged from 58 percent to 83 percent. 

The survey was designed to obtain the observations and perceptions of 

respondents on the following: (1) various aspects of results-oriented 

management topics, such as the presence and use of performance 

measures, hindrances to measuring performance and using performance 

information, and agency climate, and (2) management challenges and 

priorities at FDA. Most of the questions on the survey were closed-ended, 

meaning that, depending on the particular item, respondents indicated 

their responses on the following scale: “no extent,” “small extent,” 

“moderate extent,” “great extent,” or “very great extent.” On most 

questions, respondents also had an option of choosing the response 

category “no basis to judge/not applicable.” When reporting the survey 

results, we generally reported all responses indicating either “great extent” 

 

1

Department of Health and Human Services, U.S. Food and Drug Administration, FDA 

Strategic Action Plan: Charting Our Course for the Future (Rockville, Md.: Fall 2007). 

 FDA's Planning and Management 
Appendix I: Objectives, Scope, and 

Methodology 

or “very great extent” as “great extent” or “extensive.” We also asked some 

open-ended questions so that FDA managers could provide detailed 

written comments, such as examples of how they used performance 

information to make decisions, and more context from their point of view 

to their closed-ended answers. 

Most questions in the survey had previously been asked of a sample of 

federal managers in four earlier GAO surveys. The earliest survey was 

conducted between November 1996 and January 1997 as part of the work 

we did in response to a Government Performance and Results Act of 19932

requirement that we report on governmentwide implementation of the act. 

The second survey (conducted between January and August, 2000), the 

third survey (conducted between June and August, 2003), and the fourth 

survey (conducted between October 2007 and January 2008) were 

designed to update the results from each of the previous surveys.3

 The 

2000 and 2007 surveys, unlike the other two surveys, were designed to 

support analysis of the data at the department and agency levels as well as 

provide governmentwide data. To administer the survey, we sent an e-mail 

to members of the sample notifying them of the survey’s availability on the 

GAO Web site and included instructions on how to access and complete 

the survey. Members of the sample who did not respond were sent up to 

three subsequent reminders asking them to participate in the survey. 

The overall survey results are generalizable to the full population of FDA 

managers, as described in our definition. Our sample also allowed us to 

generalize results for managers in the following three smaller groupings at 

FDA: (1) the Center for Food Safety and Applied Nutrition; (2) the Office 

of Regulatory Affairs; and (3) the medical product centers, comprised of 

the Center for Biologics Evaluation and Research, the Center for Drug 

Evaluation and Research, and the Center for Devices and Radiological 

 

2

Pub. L. No. 103-62 § 8(b), 107 Stat. 285, 295. 

3

For information on the design, administration, and results of the four earlier surveys, see 

GAO, Government Performance: Lessons Learned for the Next Administration on Using 

Performance Information to Improve Results, GAO-08-1026T (Washington, D.C.: July 24, 

2008); Government Performance: 2007 Federal Managers Survey on Performance and 

Management Issues, an E-supplement to GAO-08-1026T, GAO-08-1036SP (Washington, 

D.C.: July 2008); Results-Oriented Government: GPRA Has Established a Solid 

Foundation for Achieving Greater Results, GAO-04-38 (Washington, D.C.: Mar. 10, 2004); 

Managing for Results: Federal Managers’ Views on Key Management Issues Vary Widely 

Across Agencies, GAO-01-592 (Washington, D.C.: May 25, 2001); and The Government 

Performance and Results Act: 1997 Governmentwide Implementation Will Be Uneven, 

GAO/GGD-97-109 (Washington, D.C.: June 2, 1997). 

Page 36 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

Health (CDRH).4 To produce generalizable results, we based our estimates 

on all respondents who completed our survey, including those not 

answering a particular question or those providing the following answer: 

“no basis to judge/not applicable.” We also included a question on whether 

respondents had performance measures for their 

program(s)/operation(s)/project(s). If respondents answered “no” or 

“don’t know” to this question or did not answer it, we placed them in the 

“no answer” category for subsequent questions on their use of 

performance information.5

 In both cases, this is the same method that we 

used in our previous governmentwide surveys on performance and 

management issues. The responses of each eligible sample member who 

provided a useable questionnaire were weighted in the analyses to account 

statistically for all members of the population. We created weights for 

each survey respondent to account for unequal probabilities of selection 

and various unit response rates among the survey strata. To do this, we 

first calculated a base weight within each survey stratum, which was the 

ratio of the population and the sample sizes within that stratum. We then 

applied an adjustment factor within each stratum to account for 

nonrespondents in the sample and to ensure accurate representations of 

known strata population totals. We conducted an analysis designed to 

identify whether results from the survey contained evidence of bias caused 

by members of the survey who did not provide responses. We compared 

weighted response rates and estimates from survey respondents with 

survey nonrespondents for several demographic variables. We did not 

identify evidence of significant bias in estimates of all FDA managers or 

estimates for managers in the three smaller groupings at FDA. Our 

accompanying e-supplement to this report provides information on the 

survey, including the weighted percentage estimates for all FDA managers 

and broken out into the three smaller groupings at FDA.6

 All weighted 

percentage estimates have a margin of error of 10 percentage points or 

less. We did not include data on demographic questions or on open-ended 

questions to preserve respondent confidentiality. 

 

4

Because the Office of Foods was not established until August 7, 2009, and the Center for 

Tobacco Products was not established until August 19, 2009, we did not include them in 

our review. 

5

Respondents had the option of reading these questions on their use of performance 

information and changing their answer to the previous question. 

6

GAO, Food and Drug Administration: 2009 FDA Managers Survey on Performance and 

Management Issues, an E-supplement to GAO-10-279, GAO-10-280SP (Washington, D.C.: 

February 2010). 

Page 37 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

In addition to sampling errors, the practical difficulties of conducting any 

survey may also introduce other types of errors, commonly referred to as 

nonsampling errors. For example, difficulties in how a particular question 

is interpreted, in the sources of information that are available to 

respondents, or in how the data were entered into a database or were 

analyzed can introduce unwanted variability into the survey results. With 

this survey, we took a number of steps to minimize these nonsampling 

errors. For example, GAO staff with subject matter expertise designed the 

questionnaires in collaboration with GAO survey specialists. Draft 

questionnaires were pretested with FDA managers to ensure that the 

questions were relevant and clearly stated. When the data were analyzed, a 

second, independent GAO analyst independently verified all analyses. This 

verification included a line by line review of all analysis programs and 

results to ensure the accuracy of the code and the appropriateness of the 

methods used for the computer generated analysis. Since this was a Webbased survey, respondents entered their answers directly into the 

electronic questionnaire, thereby eliminating the need to have the data 

keyed into a database and avoiding data entry errors. 

To identify FDA’s management challenges, we reviewed evaluations of 

FDA since January 2007 from the following sources: 2007 and 2009 reports 

from GAO’s high-risk series;7

 the Institute of Medicine’s 2008 report, HHS 

in the 21st Century: Charting a New Course for a Healthier America;

8

the Department of Health and Human Services (HHS) fiscal years 2007 and 

2008 financial reports,9

 which include the Inspector General’s yearly 

summary of management and performance challenges; and the FDA 

Science Board’s 2007 report, FDA Science and Mission at Risk.

10 To 

determine whether FDA’s 2007 Strategic Action Plan contains strategies to 

 

7

GAO, High-Risk Series: An Update, GAO-09-271 (Washington, D.C.: January 2009); and 

High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007). 

8

Leonard D. Schaeffer, Andrea M. Schultz, and Judith A. Salerno, Editors, Institute of 

Medicine of the National Academies, Committee on Improving the Organization of the U.S. 

Department of Health and Human Services (HHS) to Advance the Health of Our 

Population, HHS in the 21st Century: Charting a New Course for a Healthier America 

(Washington, D.C.: 2009). 

9

Department of Health and Human Services, Fiscal Year 2007 Agency Financial Report 

(November 2007), http://www.hhs.gov/afr/ (accessed Dec. 11, 2008); and Fiscal Year 2008 

Agency Financial Report (November 2008), http://www.hhs.gov/afr/ (accessed Dec. 11, 

2008). 

10FDA Science Board, Subcommittee on Science and Technology, FDA Science and 

Mission at Risk (Rockville, Md.: November 2007). 

Page 38 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

address identified challenges, we compared the challenges we identified 

with our analysis of the plan. We verified both our work identifying 

challenges and our work reviewing whether FDA’s Strategic Action Plan 

addressed those challenges with FDA officials. To examine the progress 

that FDA has reported toward meeting identified challenges, we reviewed 

documentation FDA provided to us in which it reported its efforts to 

address management challenges GAO identified since releasing its 

Strategic Action Plan in 2007. We also reviewed documentation from FDA 

on its fiscal years 2008 and 2009 hiring initiative, and its 2009 succession 

plan, among others. Last, we interviewed FDA officials on their efforts to 

address challenges. To determine FDA’s progress in meeting those 

management challenges, we reviewed our 2009 survey for respondents’ 

views of FDA’s progress on its management challenges. We also reviewed 

the survey for FDA managers’ detailed written responses on the top issues 

FDA’s management should address to achieve agency goals and 

responsibilities. To do this, two GAO analysts independently reviewed and 

categorized each response, then reconciled any differences in their 

independent categorizations. We reported on examples that were 

illustrative of the responses in any given category. In addition, we 

reviewed the OPM Human Capital Assessment and Accountability 

Framework (HCAAF), which provides guidance on human capital planning 

and management;11 a prior GAO report on FDA’s information technology;12

and the FDA Science Board’s assessment of FDA’s information technology 

and management.13

To determine the extent to which FDA’s annual performance measures are 

results-oriented, we reviewed prior GAO work that identified leading 

practices agencies could follow to develop results-oriented performance 

measures.14 These included all seven practices noted in our February 1999 

 

11Office of Personnel Management, HCAAF Practitioners’ Guide (Washington, D.C.: 

September 2005). 

12GAO, Information Technology: FDA Needs to Establish Key Plans and Processes for 

Guiding Systems Modernization Efforts, GAO-09-523 (Washington, D.C.: June 2, 2009). 

13FDA Science Board, Subcommittee Review of Information Technology (Washington, 

D.C.: August 2009). 

14GAO, Agency Performance Plans: Examples of Practices That Can Improve Usefulness 

to Decisionmakers, GAO/GGD/AIMD-99-69 (Washington, D.C.: Feb. 26, 1999); and 

Agencies’ Annual Performance Plans Under the Results Act: An Assessment Guide to 

Facilitate Congressional Decisionmaking, GAO/GGD/AIMD-10.1.18 (Washington, D.C.: 

February 1998). 

Page 39 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

report on articulating a results orientation as well as one practice from our 

February 1998 report, which noted that to focus on results, agencies 

should include outcome measures in performance plans whenever 

possible. We chose these practices because we determined that they had 

relevance to creating results-oriented performance measures. From these 

eight practices, we identified eight characteristics of results-oriented 

performance measures and compared these characteristics with the 48 

annual performance measures included in the President’s fiscal year 2010 

budget request for FDA. These performance measures are linked to and 

organized by FDA’s main centers and offices. As part of this comparison, 

we examined FDA’s and HHS’s strategic goals. Finally, we interviewed 

FDA officials to obtain their views on the use of results-oriented 

performance measures. 

To determine the extent to which FDA has aligned its activities and 

resources to its strategic goals, we reviewed leading practices on effective 

strategic alignment from prior GAO work and guidance from the Office of 

Management and Budget.15 We determined the extent to which FDA was 

consistent with these leading practices by comparing FDA’s strategic goals 

from its 2007 Strategic Action Plan with documentation on the agency’s 

activities and resources. Specifically, we examined portions of the budget 

requests for FDA in fiscal year 2010, including FDA’s Narratives by 

Activity, Summary of Full Cost table, and Functional Activities Tables. We 

also examined FDA’s planning documents, such as the 2007 Food 

Protection Plan,

16 the National Center for Toxicological Research’s 2009-

2013 strategic plan, and CDRH’s fiscal year 2008-2010 operational plan, 

among others. In addition, we reviewed a selection of performance plans 

covering individual FDA employees from Senior Executive Service to 

career service. We also interviewed FDA officials on their efforts to align 

activities and resources to goals. 

To review FDA managers’ use of performance information in decision 

making, we reviewed prior GAO work on enhancing agency use of 

performance information for management decision making, which 

 

15GAO, Executive Guide: Effectively Implementing the Government Performance and 

Results Act, GAO/GGD-96-118 (Washington, D.C.: June 1996); GAO-04-38; and Office of 

Management and Budget, Executive Office of the President, OMB Cir. No. A-11, 

Preparation, Submission, and Execution of the Budget, Sec. 220, p. 1 (2009). 

16Department of Health and Human Services, U.S. Food and Drug Administration, Food 

Protection Plan (Washington, D.C.: 2007). 

Page 40 GAO-10-279 FDA's Planning and Management
Appendix I: Objectives, Scope, and 

Methodology 

identified four broad types of management decisions for which federal 

managers can use performance information and five different types of 

practices that can contribute to greater use of performance information. 

To review FDA managers’ use of performance information related to these 

four types of management decisions, we analyzed responses to seven 

questions in our 2009 survey measuring managers’ reported use of 

performance information to make different management decisions. We 

identified the percentage of managers reporting that they used 

performance information to a “great” or a “very great” extent on those 

questions, and we compared those results with results from our 2007 

survey of federal managers. To review FDA managers’ reported 

application of practices to encourage the use of performance information, 

we analyzed responses to four other questions in our 2009 survey that 

measured managers’ reported use of those practices, again comparing the 

portion of “great” and “very great” responses with the results of our 2007 

survey of federal managers. We did not use the survey to review one of the 

five previously identified practices—aligning agencywide goals, objectives, 

and measures—because we addressed this issue in our third research 

objective using other research methods. In addition, we examined 

responses to our survey question asking FDA managers whether they had 

received training in six different areas related to the use of performance 

information, comparing responses with comparable results from our 2007 

survey. 

We conducted our work from December 2008 to February 2010 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, 

appropriate evidence to provide a reasonable basis for our findings and 

conclusions based on our audit objectives. We believe that the evidence 

obtained provides a reasonable basis for our findings and conclusions 

based on our audit objectives. 

Page 41 GAO-10-279 FDA's Planning and Management
Appendix II: Crosswalk of FDA’s Strategic 

Goals and Objectives to Fiscal Year 2010 Appendix II: Crosswalk of FDA’s Strategic Performance Measures 

Goals and Objectives to Fiscal Year 2010 

Performance Measures 

FDA strategic goals and objectives 

Number of related fiscal year 2010 

performance measures

Strategic Goal 1: Strengthen FDA for Today and Tomorrow 

Objective 1.1: Strengthen the scientific foundation of FDA’s regulatory mission 0

Objective 1.2: Cultivate a culture that promotes transparency, effective teamwork, and 

mutual respect, and ensures integrity and accountability in regulatory decision making 0

Objective 1.3: Enhance partnerships and communications 0

Objective 1.4: Strengthen FDA’s base of operations 2

Strategic Goal 2: Improve Patient and Consumer Safety 

Objective 2.1: Strengthen the science that supports product safety 0

Objective 2.2: Improve information systems for problem detection and public 

communication about product safety 3

Objective 2.3: Provide patients and consumers with better access to clear and timely riskbenefit information for medical products 0

Objective 2.4: Provide consumers with clear and timely information to protect them from 

food-borne illness and promote better nutrition 1

Strategic Goal 3: Increase Access to New Medical and Food Products 

Objective 3.1: Increase the number of safe and effective new medical products available to 

patients 9

Objective 3.2: Improve the medical product review process to increase the predictability 

and transparency of decisions using the best available science 11

Objective 3.3: Increase access to safe and nutritious new food products 1 

Strategic Goal 4: Improve the Quality and Safety of Manufactured Products and the 

Supply Chain 

Objective 4.1: Prevent safety problems by modernizing science-based standards and tools 

to ensure high-quality manufacturing, processing, and distribution 5

Objective 4.2: Detect safety problems earlier and better target interventions to prevent 

harm to consumers 15

Objective 4.3: Respond more quickly and effectively to emerging safety problems, through 

better information, better coordination, and better communication 1

Source: GAO analysis of FDA data. 

Page 42 GAO-10-279 FDA's Planning and Management 
Appendix III: Comments from the Department Appendix III: Comments from the of Health and Human Services 

Department of Health and Human Services 

Page 43 GAO-10-279 FDA's Planning and Management
Appendix III: Comments from the Department 

of Health and Human Services 

Page 44 GAO-10-279 FDA's Planning and Management
Appendix III: Comments from the Department 

of Health and Human Services 

Page 45 GAO-10-279 FDA's Planning and Management
Appendix III: Comments from the Department 

of Health and Human Services 

Page 46 GAO-10-279 FDA's Planning and Management
Appendix III: Comments from the Department 

of Health and Human Services 

Page 47 GAO-10-279 FDA's Planning and Management
Appendix IV: 

A

GAO Contacts and Staff 

cknowledgments 

Page 48 GAO-10-279 

Appendix IV: GAO Contacts and Staff 

Acknowledgments 

Lisa Shames, (202) 512-3841 or shamesl@gao.gov

Marcia Crosse, (202) 512-7114 or crossem@gao.gov 

In addition to the contacts named above, Sheila K. Avruch, Assistant 

Director, and J. Alfredo Gómez, Assistant Director; James D. Ashley; 

Thomas M. Beall; Kevin S. Bray; Deirdre G. Brown; Candace M. Carpenter; 

Shaunessye D. Curry; Krister P. Friday; Catherine M. Hurley; Stuart M. 

Kaufman; Martha Kelly; Julian P. Klazkin; Valerie C. Melvin; Karine E. 

McClosky; Mark R. Needham; Katherine M. Raheb; Vasiliki 

Theodoropoulos, Stephen C. Ulrich; and Russell Voth made key 

contributions to this report. 

GAO Contacts 

Staff 

Acknowledgments 

 FDA's Planning and Management 
Related GAO Products Related GAO Products 

High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 22, 

2009. 

High-Risk Series: An Update. GAO-07-310. Washington, D.C.: January 31, 

2007. 

Food Irradiation: FDA Could Improve Its Documentation and 

Communication of Key Decisions on Food Irradiation Petitions.

GAO-10-309R. Washington, D.C.: February 16, 2010. 

FDA—High-Risk 

Issues 

FDA—Food Safety 

Oversight 

Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients 

Determined to be Generally Recognized as Safe (GRAS). GAO-10-246. 

Washington, D.C.: February 3, 2010. 

Food Safety: Agencies Need to Address Gaps in Enforcement and 

Collaboration to Enhance Safety of Imported Food. GAO-09-873. 

Washington, D.C.: September 15, 2009. 

School Meal Programs: Changes to Federal Agencies’ Procedures Could 

Reduce Risk of School Children Consuming Recalled Food. GAO-09-649. 

Washington, D.C.: August 20, 2009. 

Bottled Water: FDA Safety and Consumer Protections Are Often Less 

Stringent Than Comparable EPA Protections for Tap Water. 

GAO-09-861T. Washington, D.C.: July 8, 2009. 

Bottled Water: FDA Safety and Consumer Protections Are Often Less 

Stringent Than Comparable EPA Protections for Tap Water. GAO-09-610. 

Washington, D.C.: June 22, 2009. 

Seafood Fraud: FDA Program Changes and Better Collaboration among 

Key Federal Agencies Could Improve Detection and Prevention. 

GAO-09-258. Washington, D.C.: February 19, 2009. 

Dietary Supplements: FDA Should Take Further Actions to Improve 

Oversight and Consumer Understanding. GAO-09-250. Washington, D.C.: 

January 29, 2009. 

Genetically Engineered Crops: Agencies Are Proposing Changes to 

Improve Oversight, but Could Take Additional Steps to Enhance 

Coordination and Monitoring. GAO-09-60. Washington, D.C.: 

November 5, 2008. 

Page 49 GAO-10-279 FDA's Planning and Management
Related GAO Products 

Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.

GAO-08-1047. Washington, D.C.: September 26, 2008. 

Food Labeling: FDA Needs to Better Leverage Resources, Improve 

Oversight, and Effectively Use Available Data to Help Consumers Select 

Healthy Foods. GAO-08-597. Washington, D.C.: September 9, 2008. 

Federal Oversight of Food Safety: FDA Has Provided Few Details on the 

Resources and Strategies Needed to Implement its Food Protection Plan.

GAO-08-909T. Washington, D.C.: June 12, 2008. 

Federal Oversight of Food Safety: FDA’s Food Protection Plan Proposes 

Positive First Steps, but Capacity to Carry Them Out Is Critical.

GAO-08-435T. Washington, D.C.: January 29, 2008. 

Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but 

Additional Actions Are Needed. GAO-10-68. Washington, D.C.: 

November 9, 2009. 

FDA—Medical 

Product Oversight 

Oversight of Clinical Investigators: Action Needed to Improve 

Timeliness and Enhance Scope of FDA’s Debarment and 

Disqualification Processes for Medical Product Investigators. 

GAO-09-807. Washington, D.C.: September 25, 2009. 

New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs 

Approved on the Basis of Surrogate Endpoints. GAO-09-866. Washington, 

D.C.: September 23, 2009. 

Food and Drug Administration: FDA Faces Challenges Meeting Its 

Growing Medical Product Responsibilities and Should Develop Complete 

Estimates of Its Resource Needs. GAO-09-581. Washington, D.C.: June 19, 

2009. 

Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket 

Surveillance, and Inspections of Device Manufacturing Establishments. 

GAO-09-370T. Washington, D.C.: June 18, 2009. 

Nonprescription Drugs: Considerations Regarding a Behind-the-Counter 

Drug Class. GAO-09-245. Washington, D.C.: February 20, 2009. 

Page 50 GAO-10-279 FDA's Planning and Management
Related GAO Products 

Medical Devices: FDA Should Take Steps to Ensure That High-Risk 

Device Types Are Approved through the Most Stringent Premarket 

Review Process. GAO-09-190. Washington, D.C.: January 15, 2009. 

FDA Advisory Committees: Process for Recruiting Members and 

Evaluating Potential Conflicts of Interest. GAO-08-640. Washington, D.C.: 

September 30, 2008. 

Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize 

Guidance for Pharmaceutical Interventions. GAO-08-671. Washington, 

D.C.: September 30, 2008. 

Drug Safety: Better Data Management and More Inspections Are Needed 

to Strengthen FDA’s Foreign Drug Inspection Program. GAO-08-970. 

Washington, D.C.: September 22, 2008. 

Food and Drug Administration: Approval and Oversight of the Drug 

Mifeprex. GAO-08-751. Washington, D.C.: August 7, 2008. 

Prescription Drugs: FDA’s Oversight of the Promotion of Drugs for OffLabel Uses. GAO-08-835. Washington, D.C.: July 28, 2008. 

Medical Devices: FDA Faces Challenges in Conducting Inspections of 

Foreign Manufacturing Establishments. GAO-08-780T. Washington, D.C.: 

May 14, 2008. 

Prescription Drugs: Trends in FDA’s Oversight of Direct-to-Consumer 

Advertising. GAO-08-758T. Washington, D.C.: May 8, 2008. 

Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have 

Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug 

Inspection Program. GAO-08-701T. Washington, D.C.: April 22, 2008. 

Medical Devices: Challenges for FDA in Conducting Manufacturer 

Inspections. GAO-08-428T. Washington, D.C.: January 29, 2008. 

Influenza Pandemic: Efforts Under Way to Address Constraints on 

Using Antivirals and Vaccines to Forestall a Pandemic. GAO-08-92. 

Washington, D.C.: December 21, 2007. 

Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s 

Program for Inspecting Foreign Drug Manufacturers. GAO-08-224T. 

Washington, D.C.: November 1, 2007. 

Page 51 GAO-10-279 FDA's Planning and Management
Related GAO Products 

Influenza Vaccine: Issues Related to Production, Distribution, and 

Public Health Messages. GAO-08-27. Washington, D.C.: October 31, 2007. 

Human Capital: Continued Opportunities Exist for FDA and OPM to 

Improve Oversight of Recruitment, Relocation, and Retention Incentives. 

GAO-10-226. Washington, D.C.: January 22, 2010. 

FDA—Other 

Continuing Resolutions: Uncertainty Limited Management Options and 

Increased Workload in Selected Agencies. GAO-09-879. Washington, D.C.: 

September 24, 2009. 

High-Containment Laboratories: National Strategy for Oversight Is 

Needed. GAO-09-1045T. Washington, D.C.: September 22, 2009. 

High-Containment Laboratories: National Strategy for Oversight Is 

Needed. GAO-09-1036T. Washington, D.C.: September 22, 2009. 

High-Containment Laboratories: National Strategy for Oversight Is 

Needed. GAO-09-574. Washington, D.C.: September 21, 2009. 

Information Technology: FDA Needs to Establish Key Plans and 

Processes for Guiding Systems Modernization Efforts. GAO-09-523. 

Washington, D.C.: June 2, 2009. 

Human Subjects Research: Undercover Tests Show the Institutional 

Review Board System Is Vulnerable to Unethical Manipulation. 

GAO-09-448T. Washington, D.C.: March 26, 2009. 

Veterinarian Workforce: The Federal Government Lacks a 

Comprehensive Understanding of Its Capacity to Protect Animal and 

Public Health. GAO-09-424T. Washington, D.C.: February 26, 2009. 

Veterinarian Workforce: Actions Are Needed to Ensure Sufficient 

Capacity for Protecting Public and Animal Health. GAO-09-178. 

Washington, D.C.: February 4, 2009. 

Nanotechnology: Accuracy of Data on Federally Funded Environmental, 

Health, and Safety Research Could Be Improved. GAO-08-709T. 

Washington, D.C.: April 24, 2008. 

Page 52 GAO-10-279 FDA's Planning and Management
Related GAO Products 

Nanotechnology: Better Guidance Is Needed to Ensure Accurate 

Reporting of Federal Research Focused on Environmental, Health, and 

Safety Risks. GAO-08-402. Washington, D.C.: March 31, 2008. 

Federal User Fees: Substantive Reviews Needed to Align Port-Related 

Fees with the Programs They Support. GAO-08-321. Washington, D.C.: 

February 22, 2008. 

Government Performance: Lessons Learned for the Next Administration 

on Using Performance Information to Improve Results. GAO-08-1026T. 

Washington, D.C.: July 24, 2008. 

Strategic Planning 

and Management 

Managing for Results: Enhancing Agency Use of Performance 

Information for Management Decision Making. GAO-05-927. Washington, 

D.C.: September 9, 2005. 

Results-Oriented Government: GPRA Has Established a Solid 

Foundation for Achieving Greater Results. GAO-04-38. Washington, D.C.: 

March 10, 2004. 

Managing for Results: Federal Managers’ Views on Key Management 

Issues Vary Widely Across Agencies. GAO-01-592. Washington, D.C.: May 

25, 2001. 

Performance Budgeting: Initial Experiences Under the Results Act in 

Linking Plans with Budget. GAO/AIMD/GGD-99-67. Washington, D.C.: 

April 12, 1999. 

Agency Performance Plans: Examples of Practices That Can Improve 

Usefulness to Decisionmakers. GAO/GGD/AIMD-99-69. Washington, D.C.: 

February 26, 1999. 

Agencies’ Annual Performance Plans Under the Results Act: An 

Assessment Guide to Facilitate Congressional Decisionmaking. 

GAO/GGD/AIMD-10.1.18. Washington, D.C.: February 1998. 

Managing for Results: Critical Issues for Improving Federal Agencies’ 

Strategic Plans. GAO/GGD-97-180. Washington, D.C.: September 16, 1997. 

The Government Performance and Results Act: 1997 Governmentwide 

Implementation Will Be Uneven. GAO/GGD-97-109. Washington, D.C.: 

June 2, 1997. 

Page 53 GAO-10-279 FDA's Planning and Management
Related GAO Products 

Executive Guide: Effectively Implementing the Government Performance 

and Results Act. GAO/GGD-96-118. Washington, D.C.: June 1996. 

(361018) Page 54 GAO-10-279 FDA's Planning and Management
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