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U.S. Department of Health and Human Services

About FDA

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Performance Plan Executive Summary

FDA Mission and Vision in a Dynamic Environment

For almost 100 years FDA has worked to ensure that the foods we eat and the medicines we take are safe and effective.  The effort has paid off.  This Nation's foods, drugs and biological products are generally acknowledged to be the safest in the World.   In periodic polls taken about confidence in government, FDA is repeatedly at or near the top of the list among the most trusted federal agencies. Going forward, FDA faces both new challenges and opportunities.  Challenges include the growing scope and complexity of the products FDA regulates, weighed against competing resource priorities for the Nation, including growing national security needs.  Maintaining a strong FDA is important to sustain public confidence in the products we regulate. 

FDA needs to employ efficient science-based risk management, to provide the greatest protection at the least cost.  Offsetting the challenges, FDA sees important opportunities to provide leadership to enable greater efficiency in medical product innovation and manufacturing, and to provide guidance to promote better information for consumers using FDA-regulated products.  Under the leadership of Dr. Mark McClellan, the Agency has developed a Strategic Action Plan that will successfully address these challenges --- and as a result FDA will be in a better position to materially improve the public health of the Nation.  Our consumer protection and health promotion mission will not change.  But by carrying out the initiatives outlined in the new Plan, the Agency will be able to fulfill the mission in ways that were not previously attainable. 

FDA Mission:  Consumer Protection and Health Promotion:  Since its creation in 1927, the Food and Drug Administration has faithfully carried out its core mission of consumer protection and health promotion.   And FDA will continue to be relied on by millions of Americans to safeguard their interests as the nation's premier consumer protection agency.  

FDA makes decisions that affect every American every day.  U.S. consumers spend over $1 trillion annually "more than 20 percent of their money" on products that FDA regulates.  The public relies on FDA to assure that the foods they eat and the medical products they use are safe, effective, and properly labeled.   Maintenance of these safeguards is a crucial component in improving the Nation's health.  No nation has a greater resource than the health of its people, or a duty more imperative than augmenting this asset for the coming generations.  FDA's vision for the future will enhance our ability to improve the quality of life for everyone.

Our Vision:  The FDA of the future will be an agency that provides maximum health benefits to U.S. citizens at the least cost to society.  

How will FDA do this?

  • By using rigorous science to accurately describe both the risks and benefits that consumers are subject to when using medical products or eating foods;
  • By developing "smart" regulations that help to control risks while allowing consumers to receive the maximum benefits from life-sustaining and health-giving products;
  • By providing consumers and other parties who can help promote positive health outcomes with timely and accurate information so that they can intelligently participate in controlling risk;
  • By working closely with a broad community of collaborators to provide better protection for consumers and more effectively promote their health; and,
  • By being more creative in delivering the "biggest bang for the regulatory buck."

The Outcome:  Enlightened regulation and timely information will help consumers to reap the benefits of innovation and lead healthier lives.

FDA has a sacred trust to safeguard the health of consumers.  But it is also the gateway for the myriad of new products that hold the promise of a higher quality of life for all Americans.  Our country is the world's most prolific, innovative and safe producer of foods and medical products.  The average supermarket now stocks more than 30,500 different items.  In 1982, U.S. pharmacists filled prescriptions for 7,300 FDA-approved drugs.  Today, they dispense more than 11,700 prescription drugs, many of which are the results of advanced biotechnology breakthroughs.  Such products require a much more complex and sophisticated evaluation by FDA than ever before.  Clearly, the way we regulate these products can directly affect the well-being of all Americans.  This wealth of new products is a boon for our consumers, because it helps them improve their health and better enjoy their lives.  But the speed of innovation also presents FDA with new questions to be resolved and novel guidelines and regulations to be developed.  FDA must match industry's creativity in product research and development with creative and enlightened approaches to regulating these products.

FDA Operating Principles will Pervade All that We Do - As FDA carries out the responsibilities, particular attention will be paid to key operating principles.  These principles are broad in scope and crosscut all goals and organizational components.

FDA will address highest priority risks first - We will use scientific understanding to analyze risks to the public.   We will establish risk priorities based on the analysis.  And we will reduce risks, beginning with the most critical.

FDA will manage risks throughout the product life cycle - It is important for FDA to carefully weigh the risks and benefits before deciding on the most appropriate tools for managing risks; and this consideration will occur at all stages in the product life cycle from initial research and development through manufacturing or processing, through distribution and final use by the consumer.  This method demonstrates a total systems approach to health protection and promotion. 

FDA will multiply public health impact through collaborative efforts, effective communication, and well-informed stakeholders - FDA cannot manage risks alone.  We must provide accurate, science-based information on risks versus benefits to those who will share the risk management challenge with us.  And, we must establish the most effective communication mechanisms to assure that risk information is accurately conveyed.  Our collaborators in risk management include regulatory bodies at international, federal, state and local levels; health professionals, the regulated industry and most importantly, consumers.  If all of our collaborators make well-informed decisions, the power to produce a major positive impact on public health is greatly amplified.

FDA will support and augment the policies of the Administration and the Department of Health and Human Services - Our plan will embody the President's management goal of a more streamlined, effective and citizen-centered government; and will make a major contribution to the HHS Secretary's goal of a healthier and more productive America.

FDA's Strategic Goals Will Point the Way to a Healthier America

Our strategic goals focus on launching new initiatives, which can contribute to significant progress toward achieving positive public health outcomes over the next five years.  In short, our goals aim for a strong and viable FDA that has the capability to manage and control risks associated with the products we regulate throughout their life cycle.  Goal One will targets improved risk management from initial product research and development through manufacturing and distribution.  Goal Two provides consumers with the information necessary to help them minimize their own risks.  Goal Three focuses on assuring the safety "including the safe use" of marketed products.  Goal Four helps to prepare the Nation to deal with the intentional risks introduced by terrorist acts.  And, Goal Five highlights the need to strengthen the Agency itself, in order to better carry out its public health mission.  Finally, all of FDA's goals work together to ensure that risks can be managed without unnecessarily impeding the expanding flow of beneficial health outcomes made possible by the innovative products being generated by industry.

Relationship Among the Strategic Action Plan, Performance Plan and the Budget

The five strategic goals outlined above constitute the foundation for both the Strategic Action Plan, released in August 2003, and this FY 2005 Performance Plan.   Action items that emerge from the Strategic Action Plan will have several beneficial effects on performance planning.  First, several of the action items constitute improved ways of carrying out the Agency's core business; and this should lead to higher productivity levels in existing performance goals.  Second, many of the action items enhance the Agency's ability to identify, measure and influence public health outcomes.  This improvement will result in a greater proportion of future performance goals being outcome-oriented.  Several elements of this FY 2005 performance plan are beginning to reflect both outcome goals and action items, which are the products of the Agency's current strategic action planning process.   Both the Strategic Action Plan and the Performance Plan are aligned with, and reflect the Agency's current base budget and budget increase requests.  Strategic action items for 2004 will be accomplished with base funding.  The figure below illustrates the relationship between strategic action planning, performance planning and budget formulation.

Relationship Amoing Strategic Acition Plan, Performance Plan and Budget

Relationship of the FY 2005 Performance Plan to the OMB PART Evaluation

The FY 2004 OMB PART evaluation of FDA's programs identified two key areas in which the Agency should strengthen its results orientation.  OMB recommended that the Agency develop specific long term outcome goals that were more directly associated with improvement of public health and safety; and efficiency goals that demonstrated more streamlined government operations.  FDA has responded to the OMB recommendations with a concerted effort led by our Commissioner and his leadership team.  Eight long term outcome goals were agreed upon for development and inclusion into the FY 2005 PART review and FY 2005 Performance Plan.  These goals are identified and explained in the FY 2005 Performance Plan.  Efficiency goals have also been developed and included in the FY 2005 Performance Plan.  The result of the OMB FY 2005 PART evaluation yielded an improved PART score and a rating of "Moderately Effective".  FDA will be developing baseline information for the outcome goals so that it may measure its progress.  FDA remains committed to improving processes and implementing new initiatives which will ultimately help to achieve the long term outcome goals. 

Summary of FDA's Strategic Goals, Long Term Outcome Goals
and FY 2005 Performance Goals**
FDA Strategic Goals
Long Term Outcome Goals Select Key FY 2005 Performance Goals
Efficient Risk Management

Reduce the average time to marketing approval for safe and effective new drugs and biologics.

Reduce the average time for marketing approval for safe and effective new devices.

Reduce the average time to marketing approval or tentative approval for safe and effective new generic drugs.

  • Ensure a safe and effective drug supply by meeting PDUFA III commitments for the review of original New Drug Applications (NDAs), Biologic Licensing Applications (BLAs), efficacy supplements and manufacturing supplements, and begin implementing new First Cycle Review, Continuous Marketing Application, Risk Management, IT and Performance Management initiatives.
  • Complete Review and Action upon 90% of fileable original generic drug applications within 6 months after submission date.
  • Complete the safety evaluation of 75% of food and color additive petitions within 360 days of receipt.
  • Complete Review and Action on 90% of New Animal Drug Applications and reactivations of such applications within 270 days; 90% of investigational animal drug study submissions within 285 days; and review 90% of investigational animal drug submissions consisting of protocols, without substantial data within 100 days. 
  • Complete Review and decisions on 90% of Device Premarket Approval Application (PMA) first actions within 180 days.
  • Inspect 55 of an estimated 685 registered high-risk human drug manufacturers.
  • Meet the biennial inspection statutory requirement by inspecting 50% of the approximately 2,700 registered blood banks, source plasma operations, and biologics manufacturing establishments to reduce the risk of product contamination.
  • Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material.
  • Inspect 95% of 7,200 estimated high-risk domestic food establishments
  • Perform 97,000 physical exams and conduct sample analyses on products with suspect histories.
Better Informed Consumers
Increase consumer understanding of diet-disease relationships, and in particular, the relationships between dietary fats and the risk of coronary heart disease (CHD), the leading cause of death in the U.S. and one that disaproportionally affects African-Americans and Hispanics. 

Patient and Consumer Safety

By 2008, FDA will aim for an 11% reduction in adverse drug events related to medication dispensing and administration errors in 50% of hospitals in the U.S. by requiring bar codes on drugs and biologics used in hospitals which will increase the uptake and use of bar code scanners in hospitals.

Increase by 50% the patient population covered by active surveillance of medical product safety by 2008. 

  • Enhance the postmarketing drug safety system.
    • Develop baseline for number of adverse drug events related to medication dispensing and administration errors in U.S. hospitals.
    • Develop web-based electronic drug registration and listing database.
  • Expand implementation of the MeDSuN system to a network of 250 facilities.  

Counter-terrorism

The proposed outcome goal being developed will focus on increasing the Agency's ability to test suspect foods for select biological, chemical, or radiological agents. 
  • Facilitate development and availability of medical countermeasures to limit the effects of the intentional use of biological, chemical, or radiologic/nuclear agents.
  • Enhance the Agency's emergency preparedness and response capabilities to be better able to respond in the event of a terrorist attack.
  • Expand Federal/State/local involvement in FDA's eLEXNET system by having 104 laboratories participate in the system.
A Strong FDA
The Agency will reduce the number of administrative staff by 7.5% by the end of FY 2004 and further reduce [from current FY 2003 levels] by 15% by the end of FY 2005. 
  • Implement 'shared services' concept and consolidate selected functions in the agency. 
  • Increase the percentage of commercial FTE that will be reviewed for outsourcing.
  • Acquire and implement a new core financial management system as part of the UFMS project.
  • Increase the proportion of contract dollars allocated to performance-based contracts

** The strategic goals are presented in the order shown in the FDA FY 2005 Performance Plan