FDA: An OverviewThe U.S. Food and Drug Administration is a scientific regulatory agency that touches the lives of virtually every American every day. It is FDA's job to see that the food we eat is safe and wholesome, that the cosmetics we use won't harm us, and that medicines, medical devices, and radiation-emitting consumer products such as microwave ovens are safe and effective. FDA also oversees feed and drugs for pets and farm animals. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually, at a cost to taxpayers of about $4 a person. All of FDA's effort is focused on protecting the health and safety of Americans. |
This document is the culmination of a comprehensive strategic and performance planning process led by the Commissioner and her strategic management team. The Plan outlines FDA's long-range 'corporate' goals, strategies and performance goals for FY 2001 as well as the report on FY 1999 Performance.
The Plan is divided into two Parts.
Part One describes:
Part Two presents FY 2000 and 2001 performance goals for each of FDA's programs; and a report on FY 1999 performance results. Each program section includes the following information:
This Performance Plan and the Agency budget are companion documents. Performance goals in the Summary Tables are cross-referenced to their corresponding sections in the budget document.
What Is FDA's Mission?
FDA's current mission, as adopted in the 1997 Food and Drug Administration Modernization Act, sets forth the following responsibilities for the Agency:1. To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
2. With respect to such products, to protect the public health by ensuring that--
3. To participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and,
4. As determined to be appropriate by the Secretary, to carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.
What Strategic Goals Will Sustain the Mission?
FDA pursues two strategic goals that support and sustain its public health and safety mission:
These goals are intended to create a comprehensive safety assurance system that monitors FDA-regulated products throughout their life span--from conception through consumption. Each of FDA's programs has established the same two goals, thus aligning the programs with the overall mission and goals of the Agency.
1.2.1 Agency Strategies Essential for Achieving FDA's Strategic Goals
Although timely pre-market review and post-market safety assurance are perennial Agency goals, their successful pursuit in the 21st Century will be seriously challenged by a much more complex technological, economic and social environment. FDA, at the turn of the Century, operates in a far different world than they did twenty years ago. The table below illustrates a quantum shift in the factors that will shape the Agency's future responses.
| In 1980 | At the Turn of the 21st Century |
|---|---|
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The above table provides just a flavor of the forces contributing to the challenges of this Millennium. FDA will not be able to address such complexity in the future by working independently, by relying on its current level of scientific understanding, or by attempting to protect the public from all risk situations. The task is simply too daunting. The key courses of action for FY 2001 and beyond will be to:
As the graphic below depicts, these strategies will work together to assure safety in a significantly more complex 21st Century environment.
In addition to carrying out strategies to manage complexity, FDA must continue to be responsive to the statutory review and inspection requirements mandated by the Pure Food and Drug Act, and reinforced by the FDA Modernization Act of 1997. The Performance Plan identifies goals for meeting these statutes within each program section.
Each of the strategies are described briefly below:
Strengthen the Science of the Agency
In order for FDA to achieve its safety goals in the 21st Century, it must develop the capability to regulate products of much greater complexity and sophistication than ever before. Sound science is essential for making timely and crucial regulatory decisions that impact every American citizen. A strong science capability is crucial for:
FDA must be able to apply state-of-the-art science at the point where it is absolutely essential to steward life-saving, health-enhancing products to the market. FDA is the regulatory gateway through which an estimated $50 billion in annual biomedical research and development investment must pass and be judged. If FDA cannot apply the necessary science capability at the time that products are ready to enter the market, then these products must wait.
FDA science is also critical in understanding and managing product risk in the market place. Each year hundreds of thousands of adverse experiences are reported in association with foods, drugs and medical devices. Estimated health care costs to treat these illnesses and injuries exceed $100 billion annually. Timely application of cutting-edge science will allow FDA, working with its health and regulatory partners, to quickly identify the significant risks and minimize them. This targeted action will have major health as well as economic impacts.
The FDA standard for safe and effective products, methods and processes will continue to represent the hallmark for worldwide industry, consumer and patient confidence in the 21st Century. But the Agency must assure that the intellectual capital which underpins these standards can keep pace with increasing product, method and process complexity. To illustrate:
Amplify FDA's Capabilities Through Effective Collaboration With Allies
The complexity of both risk assessment and risk management challenges in the 21st Century have grown by orders of magnitude. It is no longer plausible for FDA, working alone, to effectively address these problems. Academia, health providers, other government agencies, regulated industry and consumers all have a role to play. Simply put, to meet our public health and safety mission, FDA must work with others who share our values and our goals. These collaborations are intended to have a larger net benefit to the American public than could be achieved if the organizations worked independently. Throughout this performance plan, illustrations will be given of collaborative efforts in the areas of research, pre-market review, surveillance and education and outreach, that contribute to the success of the Agency's performance goals.
Focus on the Highest Priority Risks
In an ideal world FD A would like to completely eliminate the risk associated with consumption/use of foods, drugs, biologics and medical devices. Given limited resources, this cannot be achieved. Rather, the Agency will focus its attention on the most serious risks first. The Agency has and will continue to increase the efficiency of 'fast track' review processes in order to address the most urgent needs for new medical products first. Surveillance and compliance efforts also will continue to be directed toward identifying and taking action on the most serious threats to U.S. consumers. Several performance goals in Part Two of this plan address high priority risks.
Address Statutory Requirements in Pre-Market Review and Inspection Coverage
FDA has made significant strides toward meeting its statutory requirements to review new products within prescribed time frames--particularly in the PDUFA-funded areas which address drugs and biologics. In other pre-market review areas, and in all of the programs where biennial inspection coverage is required by statute, FDA will attempt to achieve a balance between:
1.2.2 Presidential Initiatives Contributing to FDA's Strategic Goals
Also linked to FDA's mission and strategic goals are three Presidential initiatives that represent current national priorities to prevent unnecessary death and disability. FDA plays a key role in each of these efforts. The three programs address tobacco use among youth, food safety; and bioterrorism. Each priority has been described in detail in the budget justification.
| Presidential Initiative | Description | FDA Approach |
|---|---|---|
| Tobacco Use Among Youth | To reduce the access and appeal of tobacco products to young people, to enlist retailers and others in these efforts, and to develop regulatory procedures for cigarettes and smokeless tobacco products. | Enforcement and evaluation, compliance outreach, and product regulation |
| Food Safety | To reduce the risk of foodborne illnesses and death related to microbiological contamination of domestic and imported foods. | Surveillance, coordination, inspection, education, research and risk assessment |
| Bioterrorism | To respond to chemical and biological threats from bioterrorism, FDA's roles include development of new vaccines and drugs, safeguards for the food supply, and research for diagnosis and treatment of disease outbreaks. | Coordination of vaccine development and inventory; strengthen FDA science capacity |
FDA resources are organized into seven "programs" that coincide with the organization of the President's annual budget. These programs constitute the major sections in Part Two of the performance plan
Foods -- Promotes and protects the public health and economic interest by ensuring that the food supply is safe, nutritious, wholesome, and honestly labeled. The program also ensures that cosmetics are safe and properly labeled.
Human Drugs -- Ensures that all drug products used for the prevention, diagnosis, and treatment of disease are safe and effective; and that information on proper use is available to all users.
Biologics -- Ensures the safety, potency, and effectiveness of biological products for the prevention, diagnosis, and treatment of disease. This includes blood and blood products, blood test kits, vaccines, therapeutic agents, and other biological products.
Medical Devices and Radiological Health -- Ensures that medical devices are safe, effective, and properly labeled; and that the public is not exposed to unnecessary radiation from medical, industrial, and consumer products.
Animal Drugs and Feeds -- Ensures that only safe and effective animal drugs, devices, feeds, and food additives are marketed; and that foods from animals that are administered drugs are safe for human consumption.
National Center for Toxicological Research -- Conducts scientific research to develop methods for regulatory applications.
Tobacco -- Works to reduce young people's use of tobacco through education, enforcement, and partnerships with CDC and other Federal and state health agencies.
In Part Two of the Performance Plan, each of FDA's programs has outlined strategies and identified performance goals that are aligned with and operationalize the Agency's overall strategic framework.
FDA's primary challenge in the 21st Century is to minimize product risk to the consumer as the scientific complexity of these products grows exponentially, and as trade, regulation, new health threats, and consumption patterns continue to change. To meet this challenge, FDA must call upon the capabilities of its various stakeholder communities - regulators, health partners, industry, and consumers - to generate effective solutions to these complex public health and safety challenges.
During the past year, FDA has engaged stakeholders in a series of dialogues to determine how to narrow the gap between current Agency performance and public expectations. FDA has listened closely to stakeholder suggestions and has incorporated these into many of the collaborative initiatives outlined in the FY 2001 Performance Plan. Examples of these initiatives are described in the following paragraphs.
Collaborative Institutes:
To enhance the regulatory science for medical devices, FDA plans to create a Joint Institute for Medical Devices and Radiation. Aimed at increasing intellectual capital and cooperation, the effort will represent an important step toward pulling together the knowledge from Cooperative Research and Development Agreements and contracts designed to advance CDRH regulatory science.
FDA is also proposing in FY 2001 the development of a National Regulatory Training Institute. This Institute will develop systematic training programs for safety surveillance involving participants from FDA, state and local government agencies, international regulatory authorities and industry.
The Product Quality Research Institute (PQRI) initiative will continue to be emphasized as a method of leveraging external scientific expertise to help support sound regulatory policymaking. PQRI is a nonprofit foundation that serves as a vehicle for FDA, industry and universities to collaborate on key issues in pharmaceutical product quality through research and expert group analysis. Participating members such as the American Association of Pharmaceutical Scientists, the Generic Pharmaceutical Industry Association, and the Nonprescription Drug Manufacturers Association work with FDA and other government and private organizations to determine the optimum type of information that should be submitted in drug approval requests.
FDA also continues to reap applied research benefits from its two food partnership institutes - the Joint Institute for Food Safety and Nutrition with the University of Maryland and the National Institute for Food Safety and Technology in conjunction with the University of Illinois.
Risk Management Communication and Education:
FDA is embarking on several initiatives which capitalize on collaboration with partners in order to disseminate risk management information more cost effectively than FDA could accomplish on its own. To illustrate: In a recently conducted Government-Wide Customer Satisfaction Survey, food shoppers indicated a need for more information on the nutritional content of food, particularly to at-risk groups. FDA is consulting with several organizations, including the Department of Agriculture, CDC, NIH and FTC to develop tools for educators and consumers that are designed to teach consumers how to use food labels. FDA is also working with the National Science Teachers Association to develop a supplementary food science curriculum at the middle and high school levels.
Targeted Collaboration on Critical Health Issues:
FDA scientists play key roles with many national, international and interagency organizations involved in establishing vaccine policy and practice. Examples are the National Vaccine Advisory Committee, the Committee on Infectious Diseases of the American Academy of Pediatrics; the World Health Organization; and the National Institute of Biological Standardization and Control (in the United Kingdom). FDA works on committees related to AIDS, such as the NIH HIV Vaccine Selection Committee, as well as working groups on Influenza Pandemic Preparedness, the Adult Immunization Plan, and the TB vaccine development plan.
FDA has key responsibilities for safety of the nation's blood supply. This includes standards setting and health education. The American Association of Blood Banks, the American Red Cross, state health agencies, NIH and CDC are a few partners in this effort.
In FY 2001 the Agency will continue the development of a regulatory plan related to current and new tobacco products. The Agency may organize an interdisciplinary panel with DHHS agencies such as the National Cancer Institute, the National Heart, Lung, and Blood Institute, the Office on Smoking and Health and the National Institute on Drug Abuse to consider and propose appropriate performance standards.
Integrated/Shared Surveillance Networks:
FDA is working in several venues to realize synergies in multi-organizational surveillance systems. One area of emphasis in the FY 2001 plan is the further development of an integrated sentinel surveillance network to include hundreds of participating hospitals across the U.S. Through these sentinel systems a select group of highly trained reporting facilities can provide high quality, informative reports that can be representative of user facility device problems in general.
As part of the Food Safety Initiative for FY 2001, FDA will enhance the Federal-state data-sharing capabilities of two surveillance systems, FoodNet and PulseNet, both of which are critical to the early detection and containment of foodborne outbreaks and to the detection of emerging antibiotic resistant pathogens.
The National Antimicrobial Resistance Monitoring System will also be strengthened in FY 2001. This system, initiated by FDA, CDC and U. S. Department of Agriculture helps detect whether foodborne pathogens are developing resistance to drug treatment. The system will be enhanced by increasing the number and source of bacterial isolates (human and animal) collected and the number of states covered by the system.
FDA will also continue to coordinate with the U.S. Customs Service to strengthen the Operational and Administrative System for Import Support. This is a monitoring system that screens unacceptable products from entry into U.S. commerce. As information on products and country of origin is further developed, FDA can improve their systematic profiling capabilities in order to better target potential risk.
Cooperative International Standard Setting:
FDA will continue to participate in international forums to ensure that U.S. interests are upheld in establishing standards for products under the Agency's regulatory purview. The Agency will continue to collaborate with the International Committee on Harmonization, The International Standards Organization, Codex Alimentarius, and The World Health Organization among others, to achieve this goal.
The Agency will also continue to make progress in further refining provisions of the Mutual Recognition Agreement with the European Union, and in training overseas counterparts so that those provisions can be successfully implemented.
Third Party Review, Inspection, Testing:
FDA will continue to test the concept of utilizing third parties as independent reviewers, inspectors and testers of FDA-regulated products. The goal of these initiatives will be to outsource these functions where: a) there are no compromises to the health or safety guarantees associated with these products; and b) where the use of third parties is more cost-effective than carrying out the task inside FDA.
Each of FDA's programs made significant progress toward achieving the goals that were established in the FY 1999 Performance Plan. FY 2000 and 2001 performance goals will build on the progress achieved in the past year. The Table below provides a sample of the Agency's significant achievements in FY 1999 and outlines major prospects for the next two fiscal years. The table also illustrates the versatility of FDA in achieving a strategic balance in pursuit of diverse goals.
| Program | FY 1999 Accomplishments | FY 2000 Goals | FY 2001 Goals | Significance |
|---|---|---|---|---|
| Foods | Exceeded our goals for reviewing food and color additive petitions. | Focus inspection on high risk imports and foreign food safety systems | Inspect all high risk domestic food firms annually | Reinforces agency strategy of managing highest risk in light of increasingly complex trade environment |
| Human Drugs | Approved 35 new drugs. These new products, plus the 5 new biologics approvals [see below], target diseases costing society $600 billion annually. On track to meet or exceed all PDUFA performance commitments | Launching major scientific collaboration with academia & industry to address key drug product quality issues [Product Quality Research Institute] | Expand medical error reporting & correction aimed at helping to prevent 100,000 adverse events annually. | Balanced strategic approach which includes collaboration to focus science issues, building networks to minimize adverse product effects, and rapidly stewarding critically needed drugs to market |
| Biologics | Approved 5 new biologics, including vaccines approved for Lyme disease, rheumatoid arthritis and blood disorders | Fully meet statutory inspection requirements for biologics and blood industry | Accelerate review times for standard PLA, BLA applications | Will exceed PDUFA review goals for the seventh consecutive year, while meeting statutory inspection requirements |
| Animal Drugs & Feeds | Reinvented pre-market review process in collaboration with industry to reduce future review times | Maintain strong anti-microbial resistance sampling program as part of food safety initiative | Amplify veterinary science capability through establishment of Staff College | Performance supports strengthening science capability, & working closely with collaborators to assure consumer safety throughout life span of veterinary drug development and use |
| Medical Devices & Radiological Health | Streamlined the review process to accelerate review times for important new medical devices | Develop medical device surveillance network (MedSun), which extends power of injury reports through use of representative facilities | Recruit over 200 more hospitals into sentinel system | Performance highlights reflect increasing reliance on collaboration with health professional and industry allies to address significant medical device health and safety issues — both prior to and subsequent to market entry |
| National Center for Toxicological Research | Completed method to detect 13 foodborne pathogens in one sample, resulting in faster hazard detection | Identify early indicators of cancer in highly susceptible populations | Develop methods for rapidly identifying biological warfare agents for faster response to bioterrorist threats | Performance reflects direct scientific support in addressing critical risk management decisions throughout all Agency programs |
| Tobacco | Exceeded contracting goals by signing contracts with all 50 states & 3 territories to conduct compliance checks | Conduct 200,000 compliance checks | Expand compliance checks to 228,000 | Performance goal demonstrates the amplification of FDA effort as a result of working through two important strategic alliances — with states and retailers |
Each FDA program area has been organized using a common sequence as shown below. The graphic on the next page illustrates the convention for the summary charts found within each program section (Summary of Performance Goals).
2.X.1 Program Description, Context, and Summary of Performance
2.X.2 Strategic Goals
Each program section contains two strategic goals — the first addressing effective pre-market review of products; and the second focusing on assuring safety of products once they are on the market. These strategic goals align with the agency-wide pre-market and post market strategic goals, explained in Part One of this Plan.
2.X.3 Verification and Validation
| Performance Goals | Targets | Actual Performance | Reference |
|---|---|---|---|
|
ASSURE SAFETY Maintain annual inspection coverage for mammography facilities ................. |
FY 01 Goal: 8,900 FY 00 Goal: 8,900 FY 99 Goal: None |
FY 01 FY 00 FY 99: Dec 99 FY 98: 9,413 |
P.25 |
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TOTAL FUNDING (000) |
FY 01: |
Column 1: Performance goal statements are shown in bold.
Column 2: Shows each year's intended, or "targeted," performance for that goal. If there were changes to the goal statement wording, or added or deleted goals, this will also be noted.
Column 3: Shows performance results or the anticipated date for having results for FY99 (ending on 9/30/99) and, in some cases prior fiscal years.
Column 4: Indicates where additional information can be found in the budget document, or other source.
ID Number (shown in red on the above table): Each performance goal has a unique ID number.
Total Funding: The dollars needed annually to reach the target performance under this strategic goal (dollars in thousands).
FY 00/01 Data: Results for FY 00 and 01 performance goals will be available 6 - 12 months after the end of the fiscal year.
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