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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
February 2010:
Food And Drug Administration:
Opportunities Exist to Better Address Management Challenges:
GAO-10-279:
GAO Highlights:
Highlights of GAO-10-279, a report to congressional requesters.
Why GAO Did This Study:
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 Found:
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 results-oriented. 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.
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.
View [hyperlink, http://www.gao.gov/products/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.
[End of section]
Contents:
Letter:
Background:
FDA's Strategic Action Plan Contains Strategies to Address Identified
Management Challenges, but the Progress FDA Reported Has Been Uneven:
FDA's Annual Performance Measures Are Only Partially Results-Oriented:
Although Some Progress Has Been Made, Alignment of Activities and
Resources to Strategic Goals Is Unclear at the Center and Office Level:
About One-half or Fewer FDA Managers in Our Survey Reported Extensive
Use of Performance Information and Application of Practices to
Encourage Its Use:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Crosswalk of FDA's Strategic Goals and Objectives to
Fiscal Year 2010 Performance Measures:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Identified Management Challenges and Examples of Related
Strategies in FDA's 2007 Strategic Action Plan:
Table 2: Number of FDA's Fiscal Year 2010 Performance Measures, by
Center and Office:
Figures:
Figure 1: FDA's Main Organizational Structure, as of August 2009:
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:
Figure 3: Percentage of FDA Managers Reporting Great Use of
Performance Information for Selected Management Decisions:
Figure 4: Percentage of FDA Managers Reporting Extensive Application
of Selected Practices to Encourage the Use of Performance Information:
Figure 5: Percentage of FDA Managers Reporting That They Received Six
Types of Training Related to Performance Information:
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:
[End of section]
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.
[Footnote 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.
[Footnote 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.[Footnote 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.[Footnote 4] Other entities, such as the Institute of
Medicine (IOM) and the FDA Science Board,[Footnote 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.[Footnote 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.[Footnote 7] In
light of the many concerns about FDA's 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.[Footnote
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 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 open-ended 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
results-oriented performance measures from prior GAO work.[Footnote 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.[Footnote 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 results
with the results of an earlier 2007 survey we conducted of federal
managers across the federal government.[Footnote 11] (See appendix 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.
Background:
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.[Footnote
12]
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.[Footnote 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).
[Footnote 14] Each center and office has distinct 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:
[Refer to PDF for image: illustration]
Top level:
Office of the Commissioner:
Second level, reporting to Office of the Commissioner:
* Center for Biologics Evaluation and Research;
* Center for Devices and Radiological Health;
* Center for Drug Evaluation and Research;
* Center for Tobacco Products;
* Office of Foods;
- Center for Food Safety and Applied Nutrition;
- Center for Veterinary Medicine;
* Office of Regulatory Affairs;
* National Center for Toxicological Research.
Source: FDA.
[End of figure]
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 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.[Footnote 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.[Footnote
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:
[Footnote 17] This practice can provide Congress and agency decision
makers with a better understanding of how the allocation of resources
affects mission achievement.
* 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.[Footnote
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.
FDA's Strategic Action Plan Contains Strategies to Address Identified
Management Challenges, but the Progress FDA Reported Has Been Uneven:
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 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 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: Recruiting, retaining, and developing a
workforce;
Objectives: Strengthen the scientific foundation of FDA's regulatory
mission;
Specific planned actions: Establish a 2-year FDA fellowship program.
Management challenge: Modernizing information systems;
Objectives: 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;
Specific planned actions: 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.
Management challenge: Coordinating internally and externally;
Objectives: Enhance partnerships and communications; Cultivate a
culture that promotes transparency, effective teamwork, and mutual
respect and ensures integrity and accountability in regulatory
decision making;
Specific planned actions: Establish the White Oak campus as the new
venue for scientific and cultural synergy; Develop FDA teamwork best
practices.
Management challenge: Keeping pace with scientific advances;
Objectives: 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 science-
based standards and tools to ensure high-quality manufacturing,
processing, and distribution;
Specific planned actions: 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.
Management challenge: Communicating product safety information to the
public;
Objectives: 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;
Specific planned actions: 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.
[End of table]
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.
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:
[Refer to PDF for image: horizontal bar graph]
Recruiting, retaining, and developing a workforce:
Additional staff with needed knowledge, skills, and abilities would
improve my ability to contribute: 80;
Progress made recruiting, retaining, and developing a workforce with
knowledge, skills, and abilities necessary to carry out the mission:
43.
Modernizing information systems:
Updated technologies or other tools for data sharing or information
management would improve my ability to contribute: 79;
Progress made improving information technology and information
management: 39.
Coordinating internally and externally:
Improved coordination and communication within FDA would improve my
ability to contribute: 70;
Progress made improving coordination and communication within FDA: 28.
Coordinating internally and externally:
Improved coordination and communication with other governmental
entities would improve my ability to contribute: 49;
Progress made improving coordination and communication with other
federal agencies: 19.
Keeping pace with scientific advances:
Updated scientific technologies or other tools for the regulation of a
diverse and expanding product base would improve my ability to
contribute: 67;
Progress made keeping pace with scientific advances necessary to
regulate a diverse and expanding product base: 36.
Source: GAO.
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.
[End of figure]
Recruiting, Retaining, and Developing a Workforce:
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 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
one-half of FDA managers reported that FDA was making great progress
in this area.[Footnote 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 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.[Footnote 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.
[Footnote 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.
Modernizing Information Systems:
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 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.[Footnote 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.[Footnote 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 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.[Footnote 24] We concluded that without an effective enterprise
architecture or strategic IT human capital 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.
Coordinating Internally and Externally:
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.
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
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.
Keeping Pace with Scientific Advances:
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.
Communicating with the Public:
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 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 Annual Performance Measures Are Only Partially Results-Oriented:
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 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:
* 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 Results-
Oriented 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 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.[Footnote 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: CBER;
Output and efficiency measures: 6;
Outcome measures: 0;
Total measures: 6.
Center/Office: CDER;
Output and efficiency measures: 8;
Outcome measures: 0;
Total measures: 8.
Center/Office: CDRH;
Output and efficiency measures: 0;
Outcome measures: 5;
Total measures: 5.
Center/Office: CFSAN;
Output and efficiency measures: 1;
Outcome measures: 2;
Total measures: 3.
Center/Office: CVM;
Output and efficiency measures: 2;
Outcome measures: 0;
Total measures: 2.
Center/Office: NCTR;
Output and efficiency measures: 6;
Outcome measures: 0;
Total measures: 6.
Center/Office: OC;
Output and efficiency measures: 3;
Outcome measures: 0;
Total measures: 3.
Center/Office: ORA;
Output and efficiency measures: 12;
Outcome measures: 3;
Total measures: 15.
Center/Office: Total;
Output and efficiency measures: 38;
Outcome measures: 10;
Total measures: 48.
Source: GAO analysis of FDA data.
[End of table]
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 appendix 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 results-oriented 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 intended goals. In past work, we have acknowledged
that such measures are sometimes difficult to develop.[Footnote 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, outcome-
oriented 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.
Although Some Progress Has Been Made, Alignment of Activities and
Resources to Strategic Goals Is Unclear at the Center and Office Level:
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.[Footnote 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 post-market 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.
* Production oversight covers FDA's activities related to inspections
of food and medical product facilities, import entry review,
investigations 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 pre-market 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,[Footnote 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 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 pre-market 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 pre-market 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, 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.[Footnote 29] To
provide information to Congress on the resources needed to achieve
intended results, agencies--following OMB[Footnote 30] 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.[Footnote 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.
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.[Footnote
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.[Footnote 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 the agency
should be allocating its resources differently to be more effective at
achieving its regulatory mission.
About One-half or Fewer FDA Managers in Our Survey Reported Extensive
Use of Performance Information and Application of Practices to
Encourage Its Use:
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-third to One-half 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.[Footnote 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.[Footnote 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.
[Footnote 36] (See figure 3.) For example, 47 percent of FDA managers
reported in our survey that 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.[Footnote 37]
Figure 3: Percentage of FDA Managers Reporting Great Use of
Performance Information for Selected Management Decisions:
[Refer to PDF for image: horizontal bar graph]
Identifying program problems to be addressed: 47%;
Taking corrective action to solve program problems: 48%;
Developing program strategy: 40%;
Setting program priorities: 49%;
Allocating resources: 47%;
Rewarding government employees I manage or supervise: 53%;
Identifying and sharing effective program approaches with others: 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.
[End of figure]
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:
* 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.[Footnote 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 figure 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.
Figure 4: Percentage of FDA Managers Reporting Extensive Application
of Selected Practices to Encourage the Use of Performance Information:
[Refer to PDF for image: horizontal bar graph]
FDA is investing in resources to improve its capacity to use
performance information: 27%;
FDA managers/supervisors at my level effectively communicate
performance information on a routine basis: 46%;
FDA managers/supervisors at my level take steps to ensure that
performance information is useful and/or appropriate: 47%;
FDA’s top leadership demonstrates a strong commitment to using
performance information to guide decision making: 41%.
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.
[End of figure]
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 figure 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.
Figure 5: Percentage of FDA Managers Reporting That They Received Six
Types of Training Related to Performance Information:
[Refer to PDF for image: horizontal bar graph]
Set program performance goals: 46%;
Develop program performance measures: 43%;
Assess the quality of performance data: 32%;
Use program performance information to make decisions: 34%;
Link the performance of program(s)/operation(s)/project(s) to the
achievement of FDA's strategic goals: 36%;
Conduct strategic planning: 41%.
Source: GAO.
Note: All percentage estimates in this figure have a margin of error
of plus or minus 10 percentage points or less.
[End of figure]
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.[Footnote 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.[Footnote 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 include a
module on performance measure development suitable for program
managers, but the agency does not have a timeline for this training.
Conclusions:
Along with concerns expressed by others, our work examining strategic
planning and management at FDA indicates that the agency is facing
significant management challenges that could affect its ability to
protect Americans from unsafe and ineffective products. 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-date 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 performance for 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
hinder 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 performance measures, and several of FDA's centers
and offices do not clearly track their workload according to strategic
goals. The absence of such linkages hinders FDA's and congressional
decision makers' ability to effectively understand the link between
costs and outcomes. Finally, our 2009 survey shows that fewer than one-
half of FDA managers reported receiving training on the use of
performance information. Such training could help FDA managers--and
thus FDA--make improvements in the overall use of such information.
Recommendations for Executive Action:
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.
Agency Comments and Our Evaluation:
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.
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:
* 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.
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 [hyperlink,
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 listed in appendix IV.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
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 Plan[Footnote 41]
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" 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 1993
[Footnote 42] 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.[Footnote 43] 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 Health (CDRH).[Footnote 44] 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.[Footnote 45] 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 usable 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.[Footnote 46] 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.
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 Web-based
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;[Footnote 47] the Institute of
Medicine's 2008 report, HHS in the 21st Century: Charting a New Course
for a Healthier America;[Footnote 48] the Department of Health and
Human Services (HHS) fiscal years 2007 and 2008 financial reports,
[Footnote 49] 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.[Footnote 50] To
determine whether FDA's 2007 Strategic Action Plan contains strategies
to 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;[Footnote 51] a prior GAO report on FDA's information
technology;[Footnote 52] and the FDA Science Board's assessment of
FDA's information technology and management.[Footnote 53]
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.[Footnote 54] These included all seven practices
noted in our February 1999 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.[Footnote 55] 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,
[Footnote 56] 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
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.
[End of section]
Appendix II: Crosswalk of FDA's Strategic Goals and Objectives to
Fiscal Year 2010 Performance Measures:
FDA strategic goals and objectives:
Strategic Goal 1: Strengthen FDA for Today and Tomorrow:
Objective 1.1: Strengthen the scientific foundation of FDA's
regulatory mission;
Number of related fiscal year 2010 performance measures: 0.
Objective 1.2: Cultivate a culture that promotes transparency,
effective teamwork, and mutual respect, and ensures integrity and
accountability in regulatory decision making;
Number of related fiscal year 2010 performance measures: 0.
Objective 1.3: Enhance partnerships and communications;
Number of related fiscal year 2010 performance measures: 0.
Objective 1.4: Strengthen FDA's base of operations;
Number of related fiscal year 2010 performance measures: 2.
Strategic Goal 2: Improve Patient and Consumer Safety:
Objective 2.1: Strengthen the science that supports product safety;
Number of related fiscal year 2010 performance measures: 0.
Objective 2.2: Improve information systems for problem detection and
public communication about product safety;
Number of related fiscal year 2010 performance measures: 3.
Objective 2.3: Provide patients and consumers with better access to
clear and timely risk-benefit information for medical products;
Number of related fiscal year 2010 performance measures: 0.
Objective 2.4: Provide consumers with clear and timely information to
protect them from food-borne illness and promote better nutrition;
Number of related fiscal year 2010 performance measures: 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;
Number of related fiscal year 2010 performance measures: 9.
Objective 3.2: Improve the medical product review process to increase
the predictability and transparency of decisions using the best
available science;
Number of related fiscal year 2010 performance measures: 11.
Objective 3.3: Increase access to safe and nutritious new food
products;
Number of related fiscal year 2010 performance measures: 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;
Number of related fiscal year 2010 performance measures: 5.
Objective 4.2: Detect safety problems earlier and better target
interventions to prevent harm to consumers;
Number of related fiscal year 2010 performance measures: 15.
Objective 4.3: Respond more quickly and effectively to emerging safety
problems, through better information, better coordination, and better
communication;
Number of related fiscal year 2010 performance measures: 1.
Source: GAO analysis of FDA data.
[End of table]
[End of section]
Appendix III: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
January 22, 2010:
Lisa Shames, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Shames:
Enclosed are the Departments comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: "Food and Drug
Administration: Opportunities Exist to Better Address Management
Challenges (GA0-10-279).
The Department appreciates the opportunity to comment on this report
before its publication.
Sincerely,
Signed by:
Andrea Palm:
Acting Assistant Secretary for Legislation:
Enclosure:
[End of letter]
General Comments Of The Department Of Health And Human Services On The
U.S. Government Accountability Office's (GAO) Draft Report Entitled.
"Food And Drug Administration: Opportunities Exist To Better Address
Management Challenges" (GAO-10-2791):
The Department appreciates the opportunity to review and comment on
the U.S. Government Accountability Office (GAO) draft report.
Given the timing of GAO's study, and its focus on documentation of past
strategies and management practices, the draft report represents a
baseline against which the FDA leadership can measure its ongoing
progress.
FDA agrees with GAO's Recommendations for Executive Action. Many of
these recommendations are well on their way to full implementation.
FDA Progress in Addressing Human Capital Planning:
GAO recommends that the Commissioner of Food and Drugs develop a
strategic human capital plan and issue an updated workforce plan.
FDA agrees with this recommendation. In fact, considerable progress
has been made in human resource planning. The agency successfully
conducted a hiring surge of over 2,500 staff in 2008—2009, through
coordinated workforce planning that included:
* systematic identification of staffing needs, including specific
occupational needs by Center/Office, grade levels, and locations;
* criteria for utilizing appropriate hiring authorities (e.g., Title
5, Commissioned Corps, etc.);
* coordinated approaches to offering monetary and non-monetary
recruitment incentives; and;
* a request to the Office of Personnel Management for Direct Hire
authority for many of the mission critical occupations.
This well-planned and well-executed hiring surge met or exceeded all
of FDA's hiring targets for 2009, and demonstrated FDA's ability to
recruit and hire skilled mission-critical staff across the agency.
FDA is currently engaged in the process of developing a strategic
human capital plan. In September, 2009, FDA awarded a contract to
support development of a human capital plan and updated workforce
plan. Program-level human resources (HR) planning is continuing in
support of the agency-wide plans and as a routine part of annual
operating plan development. In addition, FDA is working with RHS to
review the Rockville HR Center's progress.
FDA's Progress in Developing Results-Oriented Performance Measures:
GAO recommends that the Commissioner of Food and Drugs work to make
the agency's performance measures more results oriented.
FDA agrees with this recommendation, and is working to improve and
expand the performance measures to be included in the FY 2011
President's Budget. In fact, FDA has improved the agency's performance
measures over the past year.
For example, FDA has continued to refine its performance measures that
support the Prescription Drug User Fee Act (PDUFA), Medical Device
User Fee and Modernization Act (MDUFMA), Animal Drug User Fee Act
(ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), as part of
the periodic reauthorization of these programs. These user fee
programs incorporate a broad array of performance goals for the
agency's human drugs, biologics, medical devices, and animal drug
programs. FDA reports detailed information about program goals,
activities, and performance to Congress annually.
FDA also tracks several outcome measures. For example, FDA has
established several food safety performance goals that align with
public health outcome measures in the Healthy People 2010 program,
specifically regarding measures and targets for reducing the incidence
of infection with several common foodborne pathogens. FDA also tracks
an intermediate outcome goal to increase the number of state, local
and tribal regulatory agencies in the U.S. that are enrolled in the
Voluntary National Retail Food Regulatory Program, and which meet two
or more of the standards. FDA worked collaboratively with the Centers
for Disease Control and the U.S. Department of Agriculture's Food
Safety Inspection Service to develop results-oriented measures in
support of the White House Food Safety Working Group, and developed a
high-priority performance goal regarding reduction of Salmonella
Enteriditis infections as part of an initiative led by the Office of
Management and Budget.
FDA also has been developing logic models that link inputs,
activities, and outputs to intermediate and public health outcomes
that align with the agency's strategic objectives; drafting and
refining long-term outcome measures that align with the logic models
and strategic objectives; and developing a new comprehensive
performance tracking and management system, which FDA is implementing
in FY 2010. This new performance management approach will expand the
range of FDA's performance measures and establish regular review
meetings with senior executives to support the use of performance
information in management decision making.
Alignment of Program Activities with Agency Goals:
GAO recommends that the Commissioner of Food and Drugs direct each of
the agency's 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.
FDA agrees that Center and Office program activities should be aligned
to FDA's strategic goals and objectives.
In fact, this alignment is well established at the agency. All eight
Centers and Offices link their activities to FDA strategic goals and
objectives, not only through their planning activities but also
through staff performance management plans. All eight Centers and
Offices align their annual performance measures to FDA's strategic
objectives.
GAO notes that in FDA's FY 2009 and FY 2010 performance budget
submissions, only four Centers and Offices clearly documented the
alignment of their activities to FDA strategic goals. FDA is making
its overall alignment evident for all eight Centers in the FY 2011
performance budget submission by including a new table that links each
subprogram area to FDA's strategic objectives.
Linking Workload to Strategic Goals:
GAO recommends that the Commissioner of Food and Drugs direct the
agency's Centers and Offices to track their workload by strategic goal.
FDA agrees that such workload tracking is an important goal. The FDA's
National Center for Toxicologic Research (NCTR) and Center for
Veterinary Medicine (CVM) already have the ability to link employee
workload to agency goals. The other Centers and ORA have, to varying
degrees, partial time reporting systems and performance tracking
systems that, when viewed as a whole, provide managers with regular
information about how their employees' work relates to FDA goals.
These systems provide relevant and actionable management information
consistent with generally accepted accounting principles. FDA also
notes that its user fee reports to Congress provide solid evidence
that FDA managers are using workload information to achieve key
performance objectives.
FDA is laying the groundwork for further improvement. In December
2009, FDA awarded a contract to support the development of a
comprehensive methodology and set of tools for estimating the
resources needed to address FDA's mission responsibilities. The
workload models produced by this project will serve as a foundation
for further development of workload tracking methods that can be
linked to agency goals.
Expanding Performance Training for Managers:
GAO recommends that the Commissioner of Food and Drugs work to build
its capacity to collect and analyze performance information by
expanding training for managers on topics related to performance
information.
FDA agrees with GAO's recommendation. In fact, FDA is currently
developing a training plan and Statement of Work for helping managers
and staff analysts understand the performance budget process, develop
performance measures, and use performance information in management
decision making. FDA is planning to develop or purchase the training
modules and pilot them in FY 2010, and make the training available in
FY 2011.
Additional Comment: GAO's Comparison of 2009 and 2007 Survey Results
Regarding Training Is Invalid:
FDA appreciates GAO's efforts to conduct a survey of FDA managers, and
FDA will continue to analyze the results as it plans and implements
improvements to its programs. However, FDA has concerns about the way
GAO reported the results in the draft report.
In the draft report, GAO compares the results of the 2009 survey of
FDA managers to the results of a 2007 GAO survey of managers across
all federal agencies. The results for Question 17 in the 2009 survey
asks FDA managers if they have received six types of training related
to performance information. GAO compares this result to the finding
from 2007 for all federal managers.
This comparison is invalid. The response options (or "scale") in the
two surveys are different. FDA managers were given 3 response options
("Yes," "No," or "Not sure"), whereas the other federal managers were
given only 2 response options ("Yes" and "No"). The proportion of FDA
respondents that answered "Not sure" is substantial, ranging from 11%
to 19% across the 6 questions. Because the response options were
different, a direct comparison is inappropriate.
[End of section]
Appendix IV: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Lisa Shames, (202) 512-3841 or shamesl@gao.gov Marcia Crosse, (202)
512-7114 or crossem@gao.gov:
Staff Acknowledgments:
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.
[End of section]
Related GAO Products:
FDA--High-Risk Issues:
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 22,
2009.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-07-310]. Washington, D.C.: January 31,
2007.
FDA--Food Safety Oversight:
Food Irradiation: FDA Could Improve Its Documentation and
Communication of Key Decisions on Food Irradiation Petitions.
[hyperlink, http://www.gao.gov/products/GAO-10-309R]. Washington,
D.C.: February 16, 2010.
Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients
Determined to be Generally Recognized as Safe (GRAS). [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February
19, 2009.
Dietary Supplements: FDA Should Take Further Actions to Improve
Oversight and Consumer Understanding. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-09-60]. Washington, D.C.: November 5,
2008.
Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.
[hyperlink, http://www.gao.gov/products/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. [hyperlink, http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/GAO-08-435T]. Washington,
D.C.: January 29, 2008.
FDA--Medical Product Oversight:
Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but
Additional Actions Are Needed. [hyperlink,
http://www.gao.gov/products/GAO-10-68]. Washington, D.C.: November 9,
2009.
Oversight of Clinical Investigators: Action Needed to Improve
Timeliness and Enhance Scope of FDA's Debarment and Disqualification
Processes for Medical Product Investigators. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/GAO-09-370T]. Washington,
D.C.: June 18, 2009.
Nonprescription Drugs: Considerations Regarding a Behind-the-Counter
Drug Class. [hyperlink, http://www.gao.gov/products/GAO-09-245].
Washington, D.C.: February 20, 2009.
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device
Types Are Approved through the Most Stringent Premarket Review
Process. [hyperlink, http://www.gao.gov/products/GAO-09-190].
Washington, D.C.: January 15, 2009.
FDA Advisory Committees: Process for Recruiting Members and Evaluating
Potential Conflicts of Interest. [hyperlink,
http://www.gao.gov/products/GAO-08-640]. Washington, D.C.: September
30, 2008.
Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize
Guidance for Pharmaceutical Interventions. [hyperlink,
http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-08-970]. Washington, D.C.: September
22, 2008.
Food and Drug Administration: Approval and Oversight of the Drug
Mifeprex. [hyperlink, http://www.gao.gov/products/GAO-08-751].
Washington, D.C.: August 7, 2008.
Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-
Label Uses. [hyperlink, http://www.gao.gov/products/GAO-08-835].
Washington, D.C.: July 28, 2008.
Medical Devices: FDA Faces Challenges in Conducting Inspections of
Foreign Manufacturing Establishments. [hyperlink,
http://www.gao.gov/products/GAO-08-780T]. Washington, D.C.: May 14,
2008.
Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer
Advertising. [hyperlink, http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-08-701T]. Washington, D.C.: April 22,
2008.
Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections. [hyperlink, http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-08-92]. Washington, D.C.: December 21,
2007.
Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's Program
for Inspecting Foreign Drug Manufacturers. [hyperlink,
http://www.gao.gov/products/GAO-08-224T]. Washington, D.C.: November
1, 2007.
Influenza Vaccine: Issues Related to Production, Distribution, and
Public Health Messages. [hyperlink,
http://www.gao.gov/products/GAO-08-27]. Washington, D.C.: October 31,
2007.
FDA--Other:
Human Capital: Continued Opportunities Exist for FDA and OPM to
Improve Oversight of Recruitment, Relocation, and Retention
Incentives. [hyperlink, http://www.gao.gov/products/GAO-10-226].
Washington, D.C.: January 22, 2010.
Continuing Resolutions: Uncertainty Limited Management Options and
Increased Workload in Selected Agencies. [hyperlink,
http://www.gao.gov/products/GAO-09-879]. Washington, D.C.: September
24, 2009.
High-Containment Laboratories: National Strategy for Oversight Is
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-1045T].
Washington, D.C.: September 22, 2009.
High-Containment Laboratories: National Strategy for Oversight Is
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-1036T].
Washington, D.C.: September 22, 2009.
High-Containment Laboratories: National Strategy for Oversight Is
Needed. [hyperlink, http://www.gao.gov/products/GAO-09-574].
Washington, D.C.: September 21, 2009.
Information Technology: FDA Needs to Establish Key Plans and Processes
for Guiding Systems Modernization Efforts. [hyperlink,
http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/GAO-09-424T]. Washington,
D.C.: February 26, 2009.
Veterinarian Workforce: Actions Are Needed to Ensure Sufficient
Capacity for Protecting Public and Animal Health. [hyperlink,
http://www.gao.gov/products/GAO-09-178]. Washington, D.C.: February 4,
2009.
Nanotechnology: Accuracy of Data on Federally Funded Environmental,
Health, and Safety Research Could Be Improved. [hyperlink,
http://www.gao.gov/products/GAO-08-709T]. Washington, D.C.: April 24,
2008.
Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting
of Federal Research Focused on Environmental, Health, and Safety
Risks. [hyperlink, http://www.gao.gov/products/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. [hyperlink,
http://www.gao.gov/products/GAO-08-321]. Washington, D.C.: February
22, 2008.
Strategic Planning and Management:
Government Performance: Lessons Learned for the Next Administration on
Using Performance Information to Improve Results. [hyperlink,
http://www.gao.gov/products/GAO-08-1026T]. Washington, D.C.: July 24,
2008.
Managing for Results: Enhancing Agency Use of Performance Information
for Management Decision Making. [hyperlink,
http://www.gao.gov/products/GAO-05-927]. Washington, D.C.: September
9, 2005.
Results-Oriented Government: GPRA Has Established a Solid Foundation
for Achieving Greater Results. [hyperlink,
http://www.gao.gov/products/GAO-04-38]. Washington, D.C.: March 10,
2004.
Managing for Results: Federal Managers' Views on Key Management Issues
Vary Widely Across Agencies. [hyperlink,
http://www.gao.gov/products/GAO-01-592]. Washington, D.C.: May 25,
2001.
Performance Budgeting: Initial Experiences Under the Results Act in
Linking Plans with Budget. [hyperlink,
http://www.gao.gov/products/GAO/AIMD/GGD-99-67]. Washington, D.C.:
April 12, 1999.
Agency Performance Plans: Examples of Practices That Can Improve
Usefulness to Decisionmakers. [hyperlink,
http://www.gao.gov/products/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.
[hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18].
Washington, D.C.: February 1998.
Managing for Results: Critical Issues for Improving Federal Agencies'
Strategic Plans. [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-180]. Washington, D.C.:
September 16, 1997.
The Government Performance and Results Act: 1997 Governmentwide
Implementation Will Be Uneven. [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-109]. Washington, D.C.: June 2,
1997.
Executive Guide: Effectively Implementing the Government Performance
and Results Act. [hyperlink,
http://www.gao.gov/products/GAO/GGD-96-118]. Washington, D.C.: June
1996.
[End of section]
Footnotes:
[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, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[3] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[4] GAO, Food Safety: Improvements Needed in FDA Oversight of Fresh
Produce, [hyperlink, http://www.gao.gov/products/GAO-08-1047]
(Washington, D.C.: Sept. 26, 2008).
[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, [hyperlink,
http://www.gao.gov/products/GAO-05-927] (Washington, D.C.: Sept. 9,
2005); Agency Performance Plans: Examples of Practices That Can
Improve Usefulness to Decisionmakers, [hyperlink,
http://www.gao.gov/products/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,
[hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18]
(Washington, D.C.: February 1998); Managing for Results: Critical
Issues for Improving Federal Agencies' Strategic Plans, [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-180] (Washington, D.C.: Sept.
16, 1997); and Executive Guide: Effectively Implementing the
Government Performance and Results Act, [hyperlink,
http://www.gao.gov/products/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).
[8] GAO, Food and Drug Administration: 2009 FDA Managers Survey on
Performance and Management Issues, an E-supplement to GAO-10-279,
[hyperlink, http://www.gao.gov/products/GAO-10-280SP] (Washington,
D.C.: February 2010).
[9] [hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18] and
[hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-99-69].
[10] GAO, Results-Oriented Government: GPRA Has Established a Solid
Foundation for Achieving Greater Results, [hyperlink,
http://www.gao.gov/products/GAO-04-38] (Washington, D.C.: Mar. 10,
2004); [hyperlink, http://www.gao.gov/products/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).
[11] The 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,
[hyperlink, http://www.gao.gov/products/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, [hyperlink,
http://www.gao.gov/products/GAO-08-1036SP] (Washington, D.C.: July 24,
2008).
[12] Pub. L. No. 103-62, 107 Stat. 285.
[13] 21 U.S.C. §§ 301 et seq.
[14] 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.
[15] [hyperlink, http://www.gao.gov/products/GAO/GGD-97-180].
[16] [hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-99-69] and
[hyperlink, http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18].
[17] [hyperlink, http://www.gao.gov/products/GAO/GGD-96-118].
[18] [hyperlink, http://www.gao.gov/products/GAO-05-927].
[19] Reported 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 appendix I for more details.)
[20] GAO, High-Risk Series: Strategic Human Capital Management,
[hyperlink, http://www.gao.gov/products/GAO-03-120] (Washington, D.C.:
January 2003); and Human Capital: Sustained Attention to Strategic
Human Capital Management Needed, [hyperlink,
http://www.gao.gov/products/GAO-09-632T] (Washington, D.C.: Apr. 22,
2009).
[21] On 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: [hyperlink,
http://www.opm.gov/HCAAF_RESOURCE_CENTER/RESOURCES.ASP] (accessed on
12/14/09).
[22] GAO, Information Technology: FDA Needs to Establish Key Plans and
Processes for Guiding Systems Modernization Efforts, [hyperlink,
http://www.gao.gov/products/GAO-09-523] (Washington, D.C.: June 2,
2009).
[23] FDA Science Board, Subcommittee Review of Information Technology
(Rockville, Md.: August 2009).
[24] [hyperlink, http://www.gao.gov/products/GAO-09-523].
[25] This 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.
[26] [hyperlink, http://www.gao.gov/products/GAO-04-38].
[27] [hyperlink, http://www.gao.gov/products/GAO/GGD-96-118].
[28] [hyperlink, http://www.gao.gov/products/GAO-04-38].
[29] GAO, Performance Budgeting: Initial Experiences Under the Results
Act in Linking Plans with Budgets, [hyperlink,
http://www.gao.gov/products/GAO/AIMD/GGD-99-67] (Washington, D.C.:
Apr. 12, 1999).
[30] OMB 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.
[31] OMB Cir. No. A-11, Sec. 220, p. 1 (2009).
[32] [hyperlink, http://www.gao.gov/products/GAO-08-1047].
[33] GAO, Food and Drug Administration: FDA Faces Challenges Meeting
Its Growing Medical Product Responsibilities and Should Develop
Complete Estimates of Its Resource Needs, [hyperlink,
http://www.gao.gov/products/GAO-09-581] (Washington, D.C.: June 19,
2009).
[34] Reported 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 appendix I for more details.)
[35] [hyperlink, http://www.gao.gov/products/GAO-05-927].
[36] In 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.
[37] [hyperlink, http://www.gao.gov/products/GAO-08-1026T].
[38] See [hyperlink, http://www.gao.gov/products/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.
[39] [hyperlink, http://www.gao.gov/products/GAO-08-1026T].
[40] [hyperlink, http://www.gao.gov/products/GAO-04-38].
[41] 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).
[42] Pub. L. No. 103-62 § 8(b), 107 Stat. 285, 295.
[43] 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, [hyperlink, http://www.gao.gov/products/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, [hyperlink,
http://www.gao.gov/products/GAO-08-1036SP] (Washington, D.C.: July
2008); Results-Oriented Government: GPRA Has Established a Solid
Foundation for Achieving Greater Results, [hyperlink,
http://www.gao.gov/products/GAO-04-38] (Washington, D.C.: Mar. 10,
2004); Managing for Results: Federal Managers' Views on Key Management
Issues Vary Widely Across Agencies, [hyperlink,
http://www.gao.gov/products/GAO-01-592] (Washington, D.C.: May 25,
2001); and The Government Performance and Results Act: 1997
Governmentwide Implementation Will Be Uneven, [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-109] (Washington, D.C.: June 2,
1997).
[44] 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.
[45] Respondents had the option of reading these questions on their
use of performance information and changing their answer to the
previous question.
[46] GAO, Food and Drug Administration: 2009 FDA Managers Survey on
Performance and Management Issues, an E-supplement to GAO-10-279,
[hyperlink, http://www.gao.gov/products/GAO-10-280SP] (Washington,
D.C.: February 2010).
[47] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009); and High-Risk Series: An Update, GAO-07-310 (Washington, D.C.:
January 2007).
[48] 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).
[49] Department of Health and Human Services, Fiscal Year 2007 Agency
Financial Report (November 2007), [hyperlink,
http://www.hhs.gov/afr/](accessed Dec. 11, 2008); and Fiscal Year 2008
Agency Financial Report (November 2008), [hyperlink,
http://www.hhs.gov/afr/](accessed Dec. 11, 2008).
[50] FDA Science Board, Subcommittee on Science and Technology, FDA
Science and Mission at Risk (Rockville, Md.: November 2007).
[51] Office of Personnel Management, HCAAF Practitioners' Guide
(Washington, D.C.: September 2005).
[52] GAO, Information Technology: FDA Needs to Establish Key Plans and
Processes for Guiding Systems Modernization Efforts, [hyperlink,
http://www.gao.gov/products/GAO-09-523] (Washington, D.C.: June 2,
2009).
[53] FDA Science Board, Subcommittee Review of Information Technology
(Washington, D.C.: August 2009).
[54] GAO, Agency Performance Plans: Examples of Practices That Can
Improve Usefulness to Decisionmakers, [hyperlink,
http://www.gao.gov/products/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, [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-10.1.18] (Washington, D.C.:
February 1998).
[55] GAO, Executive Guide: Effectively Implementing the Government
Performance and Results Act, [hyperlink,
http://www.gao.gov/products/GAO/GGD-96-118] (Washington, D.C.: June
1996); [hyperlink, http://www.gao.gov/products/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).
[56] Department of Health and Human Services, U.S. Food and Drug
Administration, Food Protection Plan (Washington, D.C.: 2007).
[End of section]
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