U.S. Food and Drug Administration
Performance Plan
2002

Maintaining a Strong and Effective FDA

Desired Outcome

• Ensure that state-of-the-art scientists and health professionals are recruited and retained so that the American people can benefit from scientifically sound risk management decisions;
• Operate a streamlined Agency that is optimally organized to support mission-critical activities;
• Maximize cost-effective performance of functions by achieving a rational balance of in-house and outsourced activities; and,
• Maintain FDA's high standards as a citizen-centered agency accountable for results.

Why is FDA's Contribution Important?

A strong and effective FDA is a core element of the Nation's ability to deal with large, complex and unpredictable risks. The Agency is positioned at crucial decision making points day in and day out, which involve the health and safety of millions of citizens. The recent terrorist events only serve to accentuate the point that if FDA is not scientifically well-armed and able to move quickly and efficiently, then our Country stands on shaky ground. A weakened FDA can only move slowly and with uncertainty. Consumer confidence in the Agency suffers, and real health and safety risks may grow.

Key Strategies

Each of the strategies outlined below are aligned with the President's management objectives to make all Federal government agencies more streamlined and citizen-centered. They are intended to produce greater returns on human capital investments; more effective systems, structures and processes; and greater responsiveness to the needs of the American people.

Recruit, reward and retain state-of-the-art scientists and health professionals--FDA will continue to aggressively recruit the highest caliber professionals and utilize web-based recruiting strategies to broaden reach and accelerate access. Both monetary and non-monetary incentives are critical in rewarding the top performers in FDA's workforce.

Improve management systems--FDA continues to focus on improving the effectiveness of a wide range of systems that support Agency decisions. These include financial management, procurement, information management security, and workforce planning and performance. The Agency has embarked on several initiatives that include redesigning its financial management system, accelerating movement toward electronic procurements, integrating Agency information systems, and establishing a "continuity-of-operations" plan in the event of an emergency.

Design Effective Organizational Structures--The objective of a well-designed organization structure should be to support the mission of the organization. In FDA's case, several efforts are underway to improve organizational alignments. In response to the OMB Directive of May 8, 2001, FDA submitted a restructuring plan, based on a workforce analysis, to make the agency more streamlined and "citizen-centered." The Agency has also awarded a contract to determine the most effective configuration of administrative functions, and will be implementing contractor recommendations during FY 2002 and FY 2003.

Achieve cost-effective performance of traditional government activities--FDA has committed to examining its' commercial FTE to determine which activities would be more cost-effective if outsourced. The aim is to arrive at a rational balance of in-house and outsourced activities that will maximize overall cost-effectiveness.

Respond to citizens' needs--In 1997, Congress enacted the FDA Modernization Act, which reaffirmed the Agency's long tradition of collaboration with our constituents. Section 406(b) of the Modernization Act directed the Agency to consult with our constituencies to ensure that we fulfill our statutory mandates and that we communicate clearly with our stakeholders. FDA continues to hold frequent meetings with its stakeholders to gather views on regulatory issues and discuss a variety of public health issues. FDA has worked very hard to ensure that everyone affected by the Agency's actions has a voice, and that each voice is heard. While all of these voices may not share the same viewpoint, we have found that this open discourse can engender confidence.

The latest Pew Foundation study reported that over three quarters of consumers, health professionals, patients, and industry representatives say they trust FDA to make the right decisions--more than twice the approval rate for government as a whole.

However, despite these positive signs, FDA must work to remain vigilant in its responsibilities to the American public. FDA's collaborative efforts with other Federal and State governmental agencies, regulated industry and the American public, will ensure that the safest and most effective products are made available in a timely manner, and that critical product safety information is relayed to the American public and health care professional quickly.

Current Status and Barriers to Further Progress

Human Capital --Progress varies. In terms of recruiting and retaining the necessary skill base, FDA is faced with the challenge of replacing its critical knowledge base as a large aging segment of its workforce reaches retirement age. Monetary incentives continue to challenge FDA and other federal agencies because we simply cannot match private sector salaries. In order to enhance competitiveness with industry, FDA would need greater flexibility in recruitment strategies and in pay incentives. While appointment mechanisms in the excepted service, i.e., Title 42 of the Public Health Service Act, offer some relief, they are not appropriate for all hiring situations.

Congress funded pay increases in FY 2002. The provision of pay increases as part of the FY 2003 budget request to Congress will go a long way toward re-establishing incentives among both manager and employees.

On the other hand, FDA has initiated non-monetary, quality of work life incentives that are having a major positive impact. This is reinforced by recent surveys of federal employees, where FDA respondents gave their agency a 72 percent favorable rating in employee job satisfaction--highest of the 49 agencies surveyed.

Management Systems--There is also mixed progress in the area of management systems. There are a few bright signs. FDA has realized $14 million in cost avoidance in FY 2000 through innovative procurement methods. But there are also major issues. Cyber security remains a critical IT management challenge for FDA in FY 2002 and beyond. In light of anticipated terrorist threats, FDA has established a goal to develop a continuity-of-operations plan in FY 2002.

Organization structure--Some common challenges are also being addressed across all of the Agency's organizational structures. These include: determining the appropriate degree of centralization vs. decentralization; maintaining alignment with the mission and strategies of the Agency; arriving at a reasonable balance between system stabilization and system adaptation--particularly to new technologies; and determining cost-effective approaches to streamlining.

FDA also continues to implement its plan to consolidate headquarters facilities with the aim of improving the cost effectiveness of headquarters operations. Facilities that are now scattered among many locations will be concentrated in two locations in White Oak and College Park, Maryland. Currently, FDA Headquarters is located in 40 buildings in 18 locations. As a part of the FDA Revitalization Act, FDA has embarked on a five-year plan to relocate the major portion of its headquarters personnel to White Oak Maryland. This project, coupled with ongoing efforts to reduce supervisory ratios and delayer headquarters staff will afford FDA maximum flexibility to move resources closer to the day-to-day "front line" programmatic work of the Agency.

Specific performance commitments for FY 2002 and FY 2003 and actual performance from FY 2001 are outlined in the table that follows.

Performance Goals Summary

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