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I am proud to present the Food and Drug Administration's Strategic Action Plan, which sets forth our long-term strategic goals and objectives. The plan also details specific actions we are committed to taking over the next eighteen months as we carry out our mission of promoting and protecting the public health.
Leading any organization is in some respects analogous to navigating challenging rapids in a white-water raft. Both tasks involve dealing with day-to-day crises (or getting through the toughest rapids on the river) while charting a strategic course that allows the organization to fulfill its mission over the long haul (navigating the raft safely to the chosen destination). Leading the FDA is no exception – and if anything the scope and complexity of our public health responsibilities makes planning ahead an even greater challenge.
This new Strategic Action Plan charts our course for the future, focusing on four strategic goals: strengthening the FDA, improving the safety of patients and consumers, increasing access to new medical and food products, and improving the safety and quality of manufactured products and the supply chain. Each of these goals represents a fundamental public health task that is crucial to fulfilling our mission.
As specific and as detailed as this plan is, however, it will account for nothing unless we use it as a blueprint for our public health work over the next year-and-a- half. For in the end, this Strategic Action Plan is all about trust. It is about establishing trust by doing the right thing, and by doing it in the right way.
If we can accomplish what we propose – and I have no doubt that we can and will – then we will strengthen the trust of the public that we serve.
I would like to thank all the FDA employees from across the agency who contributed their ideas, suggestions, experience and talent to this strategic plan. I would also like to thank each and every FDA employee for their dedication to our public health mission. It is an honor to serve as Commissioner of Food and Drugs, and I look forward to working closely with FDA employees and stakeholders alike as we strive to accomplish all goals of this Strategic Action Plan.
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
FDA Strategic Action Plan
Table of Contents
Objective 1.1: Strengthen the scientific foundation of FDA’s regulatory mission.
Objective 1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making.
Objective 1.3: Enhance partnerships and communications.
Objective 1.4: Strengthen FDA’s base of operations.
Objective 2.1: Strengthen the science that supports product safety.
Objective 2.2: Improve information systems for problem detection and public communication about product safety.
Objective 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products.
Objective 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.
Objective 3.1: Increase the number of safe and effective new medical products available to patients.
Objective 3.2: Improve the medical product review process to increase the predictability and transparency of decisions using the best available science.
Objective 3.3: Increase access to safe and nutritious new food products.
Objective 4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution.
Objective 4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers.
Objective 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.
In this document we describe the FDA Strategic Action Plan, including the long-term mission goals and objectives identified by senior management. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA’s public health mission and to fulfill our role in supporting the larger mission and strategic goals of the Department of Health and Human Services. In this document we also describe the specific actions we will undertake within the next eighteen months, to deliver major progress toward these goals and objectives.
FDA must maintain the balance of protecting and promoting public health. US consumers rely on FDA to protect them from unsafe medical products and contaminated food. This is our first and foremost responsibility. We are also charged with promoting public health, by guiding and supporting the continued development and availability of safe and effective new medical technologies and safe and nutritious new food products. We do this to ensure that US consumers benefit from the latest science and technology to improve their health and well being. However, new medical and food technologies will always present uncertainties about benefit versus risk. In determining whether a new product can be marketed to consumers FDA must make a determination of the benefit versus risk based on the best available science. New information may later become available that will require revising our earlier assessment of benefits and risks. Given this reality of advancing science and emerging information, we have come to view our public health responsibilities in terms of the entire life cycle of the product—from the earliest data on benefit-risk to long experience with marketed use, and spanning the supply chain from source of ingredients to point of consumption.
HHS Mission: The HHS mission is to enhance the health and well-being of Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.
FDA Mission: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
To effectively perform our public health mission we must recognize and address important challenges resulting from continuing changes in technology, markets, and consumer needs.
Each of these trends provides FDA a challenge but also an opportunity for innovation and more effective use of technology and partnering to achieve our mission. We must also strengthen public confidence in FDA’s ability to protect and promote the public health by improving operating infrastructure and modernizing regulatory processes, and maintaining scientific independence.
This strategic plan marks the path to achieve our vision for FDA in the 21st Century. That vision calls for an organization that is dedicated to excellence as a science-based and science-led regulatory agency that provides global leadership in protecting public health. To do this we will harness the science of molecular medicine and nutritional health. Recognizing that new scientific findings will increase and evolve our knowledge and understanding of product risks and benefits, we will take a comprehensive Quality Systems approach to ensure safety through the entire lifecycle of regulated products. Our quality systems approach will emphasize prevention, improve our capability to detect and isolate problems, involve development of a more robust response capability, and improvement of our ability to facilitate recovery.
We cannot address these challenges and achieve our vision single-handedly. FDA will partner with other public agencies and private entities to implement better systems, facilitate development of new technology to ensure the safety and integrity of the product supply chain, and better-informed, safer product use.
Our vision for FDA in the 21st Century calls for an organization that is dedicated to excellence as a science-based and science-led regulatory agency that provides global leadership in protecting public health. New molecular discoveries and new materials, including bioengineered tissue, and new technologies including nanotechnology, robotics and others are ushering in a new generation of products including therapies for personalized medicine. Evaluating these products will involve many sources of data and conflicting information related to new products and currently marketed ones. New science will raise new questions and new sources of uncertainty about effectiveness and safety. To achieve the best public health protection FDA will need the best scientific talent and expertise, and an environment that applies rigorous standards and encourages vigorous debate.
To ensure the best public protection now and in the future our first goal is to strengthen FDA for today and tomorrow. We’ll achieve this goal by pursuing the following objectives:
Scientific and biomedical advances will create unprecedented demands on FDA’s ability to maintain a strong and contemporary workforce. Yet, today, there are few programs equipped to train individuals in regulatory science -- how to apply new biomedical discoveries to product evaluation.
A new Food and Drug Administration Fellowship Program will be the cornerstone of FDA’s personnel succession planning efforts. The goal of this Fellowship Program is twofold: to ensure that FDA has a robust and skilled workforce capable of meeting its mission today and into the future; and to enable FDA to respond quickly to the Agency’s hiring and leadership needs, especially in mission critical occupations.
The two-year fellowship program will be designed to recruit and retain prospective candidates from scientific and administrative disciplines essential to fulfilling FDA’s mission. This program will provide the candidates a vehicle for developing and enhancing their scientific, regulatory, leadership, and business skills through experiential learning and training. As part of the program, each candidate will be assigned to a position appropriate to their expertise within a Center. In addition to their position within FDA, they will be given other opportunities to augment their skills through rotations, professional forums, and competency training.
Once established, this program will become part of the FDA culture and will provide a mechanism for the FDA to attract individuals with expertise essential to FDA’s mission (for example, expertise in cutting-edge scientific disciplines) and who are eligible to become part of the FDA workforce.
Our first objective under Goal 1 is to strengthen and sustain FDA’s scientific expertise, to be ready to ensure safety and continued development of innovative technology. We will pursue this objective through the development of a new collaborative program that will bring new scientific staff fellows to FDA [see box text: FDA Fellowship Program]. This program will provide these new scientists and technical experts with valuable experience with regulatory decisions involving path-breaking technologies and critical safety questions. The program will in turn provide FDA with access to new scientific talent with relevant research and applied experience.
To ensure significant progress in strengthening the science base of FDA’s mission, we will take the following specific actions within the next 18 months:
(1) Scientific Track - provides opportunities for individuals with a science background to learn about and participate in FDA-related regulatory review and research functions and to interact with other public and private sector agency personnel to enhance regulatory science.
(2) Administrative Track – provides opportunities for individuals with an administrative background to learn about and participate in various activities aimed at improving the efficiency and effectiveness of operations in the Center/Office to which he/she is assigned.
Next Steps: We will have a business plan established and cleared through FDA by the fourth quarter 2007
To ensure that FDA continues its record of excellence as a regulatory agency, we must apply methods of scientific analysis with consistency, uniformity, and integrity. And though the data we review may be proprietary, our decision processes must be transparent and open to scrutiny, allowing for diverse points of view and vigorous debate. Assessing the risk and benefit of medical products and food ingredients is extremely difficult and requires various individual skills that are integrated and coordinated. At the FDA we can excel as individuals, but patients and the public benefit the most through our close and productive working relationships and interactions. Thus the focus of this objective is the development of effective teams in performing all of our regulatory functions.
To ensure significant progress in cultivating a culture that promotes transparency and effective teamwork, we will take the following specific actions within the next 18 months:
To better leverage limited resources and maximize protection of public health, we need to build effective partnerships with other organizations with shared goals and capabilities that can enhance the agency’s efforts. These collaborations include but are not limited to state and international regulatory partners, to study and monitor medical products throughout their entire life cycle. Working closely with our counterparts abroad, whether in generating data about potential new therapies or monitoring their safe use, represents yet another way this agency strives to carry out its mission of promoting and protecting the public health.
We can also leverage the capabilities of health professionals and the public by providing more and better information related to benefits, risks and safe use of FDA-regulated products.
To ensure significant progress in enhancing partnerships and communications, we will take the following specific actions within the next 18 months:
Science-led modernization of FDA regulatory processes will require modernized facilities to support more efficient operations with current-state technologies. It will also require innovative approaches to expand access to scientific expertise to integrate emerging science into regulatory processes. FDA operations in the 21st century will require modern information infrastructure and information management to enable quantum improvements in data-driven regulatory decision processes. It will also require vigorous enterprise-wide management and coordination of resources, especially people, budget, and facilities.
To ensure significant progress in strengthening FDA’s base of operations, we will take the following specific actions within the next 18 months:
The quality of information available to guide decisions of medical professionals and consumers on products can vary widely in terms of the information’s accessibility and accuracy. All of a product’s benefits and risks are not known at the time of pre-market review and our current passive post-market safety surveillance system is inefficient and provides incomplete, sometimes confusing, safety signals. More advanced science (e.g., using biomarkers, genetic testing, etc.) is needed to develop safer products and testing methodologies to guide safe use. Better informatics is needed to enable easy and accurate reporting of any safety problems from regulated products, and to obtain ready access to large population databases for real-time analysis of the clinical context in which the safety problems occur. We also need more effective and timely communications with patients and consumers to explain what is known and not known in a manner that best supports their decision making regarding use of regulated products.
We plan to overcome these challenges by improving scientific methods and technologies and initiating a life cycle approach to ensuring product safety through a vigorous proactive safety program. We will achieve this goal by pursuing the following objectives:
Our recently announced Medical Product Safety Initiative is a signature effort supporting Goal 2 (see text box on next page).
The safety of drugs and other medical products regulated by the U.S. Food and Drug Administration (FDA) has always been, and continues to be, a key focus of FDA's programs. This issue is of vital importance to the health of the United States public and to the mission of FDA. FDA is committed to having a state-of-the-art drug safety system. Emerging science and technology are driving a transformation of all aspects of medicine including drug safety. FDA is keeping pace with this transformation through a series of changes and improvements to its drug safety system.
The Agency will accomplish this transformation by:
The science of safety is still evolving. We will work collaboratively to maximize patient and consumer safety through new and more precise molecular information to predict patient risk, state-of-the-art systems for safety surveillance and effective risk communications, and modernize drug development and regulatory processes using a life cycle approach. Through several new initiatives such as the personalized medicine initiative, FDA will improve the safety, quality, and effectiveness of healthcare through medical products tailored to meet each patient’s needs. We will also expand the science that identifies food safety threats, sources of contamination, their mode of spread, and options to prevent contamination and focus the food safety system on prevention rather than reaction.
To ensure significant progress in strengthening the science that supports product safety, we’ll take the following specific actions within the next 18 months:
FDA has long needed to transform its approach for identifying pre- and post-market safety signals. Specifically, we need to develop tools and methods for active post-market surveillance, build pre-competitive data libraries to research safety data across medical products, upgrade existing adverse event reporting systems, and institutionalize these tools throughout FDA business. Over the next several years, FDA will seek access to data bases that will identify the full array of safety problems across populations and sub-populations, develop alternative data mining and signal detection methods for medical products safety analysis, develop data management tools that provide reviewers with current information and the ability to track safety signals over time, and create a single web-based portal, known as MedWatch Plus, for reporting of adverse events associated with all FDA-regulated product, among many other initiatives.
To ensure significant progress in improving the information systems that support product safety, we’ll take the following specific actions within the next 18 months:
FDA’s responsibility to ensure safe use of medical products does not end at the pharmacy or retail shelf. Even the safest medical product can be dangerous if used at the wrong dose, by the wrong person, or in the wrong way. Often, the risk-to-benefit balance is not clear. As medical products and medical science become increasingly complex, and as patients increasingly use multiple medical products at once, patients and their health care providers must make difficult treatment choices in the face of significant unknowns.
To ensure significant progress in improving communications on the benefit versus risk of medical products we’ll take the following specific actions within the next 18 months:
FDA will change the strategy of the food safety program from a reactive system to a proactive system that is focused on prevention. We will be working with industry, other federal agencies and international health organizations to identify problems sooner, improve communication and ensure rapid notification of risks from tainted food products. We will promote health by assuring that our food is not only safe but nutritious. Our Food Protection Plan represents a major new effort in this area (see text box below).
We are also working to develop a new generation of validated risk communication methods that will increase the public’s ability to use product information to improve diet and health and to reduce the risk of food borne illness. We will also promote healthy choices by ramping up efforts to educate the American public on the relationship between diet and disease and enhancing consumer nutritional information.
Within its current regulatory framework, FDA has accomplished much to ensure the safety and security of human and animal foods. Nevertheless, it is clear that global food sources along with new methods of production, distribution and consumer demand combined with an increasingly susceptible population means we are continually dealing with new challenges and risks to the safety and security of the Nation’s food supply. Having a safe and secure food supply is critical for public health and the economy of the United States, and as part of our national infrastructure of vital commodities.
To respond to today’s challenges, FDA will focus a greater emphasis on preventing food safety problems before they occur and, if prevention fails, responding rapidly to minimize the public health impact. This shift to prevention is at the core of FDA’s proposed food protection strategy which will be accomplished through prevention, interventions, and response.
To strengthen its efforts to prevent contamination, FDA plans to strengthen support of food industry efforts to build safety into products manufactured either domestically or imported. The FDA will work with industry, state, local, and foreign governments to identify vulnerabilities and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.
The plan's intervention element emphasizes focusing inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports.
The plan calls for enhancing FDA's information systems related to both domestic and imported foods to better respond to food safety threats and communicate during an emergency.
The Food Protection Plan's three core elements--prevention, intervention, and response--incorporate four cross-cutting principles for comprehensive food protection along the entire production chain:
To ensure significant progress in improving the information on food safety and nutrition we’ll take the following specific actions within the next 18 months:
Between 1994 and 2003, public and private biomedical research funding in the United States doubled (when adjusted for inflation, from $37 billion to $94 billion). This investment is already paying off, in the form of new information about the human genome, new biomedical materials, and molecular-level analysis. But this biomedical revolution has not delivered on its promise of better health and health care. New medical product submissions to FDA are flat or declining, and 2004 was a new low world-wide in the number of new molecular entities launched. Many diseases still lack effective treatment, while the cost of new medical product development is higher than ever.
Through Strategic Goal 3, FDA science will become a bridge to medical product innovation and the era of personalized medicine, and help Americans have greater access to benefits from the National Institutes of Health's investment in biomedical research. FDA can harness the new genetic and molecular sciences, new advances in imaging and bioinformatics, and other biomedical breakthroughs to create a new generation of cutting edge scientific regulatory standards that provide both predictability and enhanced efficiencies for product development. Such standards will incorporate new tools that better predict a product’s efficacy and/or safety, and do so earlier in the development process. This will help sponsors shorten medical product development time, identify unpromising products earlier in development, and get more products with more promise into the development pipeline.
Specific examples of such tools -- new biomarkers, better clinical trial designs and endpoints, in silico testing, standards to accelerate review of generic animal drugs -- are included in the Action Items, below.
Through concrete actions such as the following, FDA will create a new generation of product development science, so that product sponsors will have the information and predictability they need to increase the efficiency and effectiveness of their product development strategies.
The FDA’s Critical Path Initiative harnesses the latest discoveries – in genomics, proteomics, tissue engineering, imaging, and bioinformatics – to improve the efficiency and effectiveness of product development, evaluation, and manufacture.
First Steps
Starting with medical products, in 2004, FDA issued a report outlining the path for identifying scientific hurdles that impede medical product development, and calling for a national effort to modernize the product development sciences. FDA issued a follow-up report in March 2006, describing 76 concrete scientific impediments to product development identified by our outside stakeholders and inside experts.
Today
FDA, through an array of public-private partnerships, has initiated efforts to solve more than a dozen of these hurdles. The Initiative has rapidly matured and is now poised to yield benefits across all medical product areas. In addition, FDA recognized that the need to modernize the product evaluation sciences is not limited to human medical products, and has added veterinary and food product regulatory science to the Initiative.
Today, FDA is building on its unique position to work with outside stakeholders to identify areas ripe for improvement, and to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating FDA regulated products.
Tomorrow’s Promise -- Personalized Medicine
Many Critical Path tools (such as new biomarkers and more informative clinical trial designs) also produce enhanced information about the safety and efficacy of the product, information that health care providers can use to tailor therapies to the individual needs of patients – the foundation of personalized medicine.
For example, better methods for selecting patients and assessing their responses during a clinical trial can translate directly to better methods of diagnosing and monitoring patients in the clinic, and better methods for targeting treatments to the patients who are most likely to benefit. Such tools will help bring individualized medicine into the physician’s office, to help shape the medical practice of the future.
To ensure significant progress in improving the medical product review process we will take the following specific actions within the next 18 months:
FDA will modernize the scientific tools that support product review, and the corresponding review processes, to reflect the new generation of product evaluation tools and the innovative products we expect to see over the next decade. To ensure transparency, FDA will publish new guidances to reflect these changes.
To ensure significant progress in improving the medical product review process we will take the following specific actions within the next 18 months:
FDA will encourage the development and acceptance of innovative food products that enhance the availability of safe, nutritious foods through the development of new or revised standards, guidance, recommendations, or other tools. We will explore novel scientific approaches (e.g. nutrigenomics) to better understand how the unique attributes of individuals affect the assessment of safety of foods, food components, nutrients, and dietary supplements. We will also work with international and intergovernmental bodies such as Codex Alimentarius on the harmonization of international standards, guidance, recommendations, and risk analysis principles.
To ensure significant progress to increase access to safe and nutritious food products we will take the following specific actions within the next 18 months:
FDA’s oversight of manufacturing, production, and the supply chain plays a critical role in assuring the safety of food, cosmetics, and radiation-emitting devices, and assuring the quality and safety of medical products. FDA prevents problems in the supply chain by developing standards and guidance for industry to promote best practices that reduce risk. We protect the safety of patients and consumers through intervention activities, such as inspection of the manufacturing supply chain, to make sure that unsafe manufacturing conditions are discovered and unsafe products are removed from the supply chain before they can do harm. As a final line of protection, FDA responds as quickly as possible in a targeted manner so that any problems that do slip through our system of protections are contained and mitigated, allowing more rapid recovery of normal economic and social activities.
FDA faces a variety of strategic challenges in meeting this area of our mission. The technologies used to produce FDA-regulated products have been changing more rapidly, which means that FDA’s work force must adapt and continue to learn to keep up with the state of science and technology. We now live in a fast-paced global economy, where the sources of products and their ingredients come from all over the world, and finished products made in America are distributed around the world. Moreover, economic development has increased the volume and variety of regulated products, which drives up the regulatory workload. Solutions to these challenges will come from a variety of directions, including:
As part of FDA’s public health mission, we have a responsibility to efficiently detect counterfeit, adulterated, misbranded, or illegally marketed or imported products, and to intervene before they cause harm. Moreover, we need to respond quickly to minimize harm and isolate the problem in the event of an emergency that involves any hazardous FDA-regulated products that may have reached the marketplace. Therefore, it is critical that the Agency have accurate, complete, and up-to-date information on every regulated firm, facility, and establishment, as well as the products that are produced or flow through those facilities or establishments.
Currently, FDA addresses these tracking needs through a multitude of methods and databases that have evolved separately within each regulatory program over many years. Under the new Harmonized Tracking of FDA Regulated Entities initiative, FDA will harmonize and modernize the information management and business processes for tracking regulated establishments and their products. This will improve the regulatory processes that ensure product quality by making them more efficient, more reliable, and more consistent across the Agency. Two components of this initiative are the Electronic Drug Establishment Registration and Product Listing initiative, which covers human and animal drugs and biologics, and the electronic Medical Device Registration and Listing initiative.
Under these initiatives, FDA will use technology and business process improvement techniques to transition from outdated paper-based systems to harmonized electronic systems that ensure quick access to all product and establishment information. These systems will provide for electronic input and access to complete information developed in part through electronic labeling. This will greatly improve the efficiency and effectiveness of operations involving the screening of imported products, review of regulated products, identification and monitoring of violative products, and recall of inappropriate or defective products. The harmonized systems will provide a master inventory of products and establishments, eventually allowing the elimination of inefficient paper registration and listing forms, so that FDA can focus more of its resources directly on safety and public health issues. The harmonized systems will be cost effective for both industry and the government because the data reporting elements will be streamlined to avoid duplication of data reported to other program databases, and they will provide accurate, complete, and up-to-date information on all FDA regulated firms, facilities, and establishments and their marketed products.
Given the trends and challenges we face, FDA has formulated the following strategic objectives in this goal area.
One of the most important tools FDA has to protect public health is the development of science-based guidance and standards that help industry to efficiently comply with FDA regulations, as well as guide them toward best practices. As science and technology advances, and as economic and social trends evolve, FDA must continually evaluate the standards and guidance to ensure that we are promoting the best and most current recommendations. Investment in prevention is a high priority, as that yields the greatest payoffs to public health.
To ensure significant progress in modernizing science-based standards and tools to prevent safety problems we will take the following specific actions within the next 18 months:
No prevention program is perfect; hence FDA also focuses on a second line of protection by intervening when problems are detected – before the problem can cause harm. Through more advanced risk-based targeting of inspections, more efficient and accurate inspection and compliance protocols, and more rapid analysis methods, we seek to improve our ability to prevent exposure to harmful products.
To ensure significant progress to better target interventions we will take the following specific actions within the next 18 months:
Despite everyone’s best efforts, accidents can happen. FDA also devotes its attention to improving our ability to respond quickly and effectively when unsafe food or medical products do make their way into the market.
To ensure significant progress to respond more quickly and effectively to emerging safety problems, we will take the following specific actions within the next 18 months:
As FDA celebrates more than 100 years of service to the American people as the world’s gold standard regulatory agency, it looks to the future. The future holds unprecedented promises for healthier and safer lives for everyone. The products of explosive progress in science and technology have made that future a possibility and not just a promise but the pathway requires FDA to look ahead to being a bridge and not a barrier to the delivery of safe and nutritious food and life-saving medial and health products to the people we serve. This strategic plan marks the path to achieve our vision for an organization that is dedicated to excellence as a science-based and science-led regulatory agency that provides global leadership in protecting public health. In this document we presented the goals and objectives that frame our efforts and identified the milestones we will achieve to mark major progress over the next eighteen months.
APPENDIX A:
FDA Strategic Goals and Objectives Aligned with DHHS Strategic Goals
| DHHS Strategic Goals | DHHS Strategic Objectives | FDA Strategic Goals | FDA Long-term Objectives |
|---|---|---|---|
| 1 : Health Care - Improve the safety, quality, affordability, and accessibility of health care, including behavioral health care and long-term care. | 1.2: Increase healthcare service availability and accessibility | 3: Increase Access to New Medical and Food Products | 3.1: Increase the number of safe and effective new medical products available to patients. |
| 1.3: Improve health care quality, safety, cost, value | 2: Improve Patient and Consumer Safety | 2.1: Strengthen the science that supports product safety | |
| 2.2: Improve information systems for problem detection and public communication about product safety. | |||
| 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products. | |||
| 3: Increase Access to New Medical and Food Products | 3.1: Increase the number of safe and effective new medical products available to patients. | ||
| 3.2: Improve the medical product review process to increase the predictability and transparency of decisions using the best available science. | |||
| 3.3: Increase access to safe and nutritious new food products | |||
| 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain | 4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution. | ||
| 4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers. | |||
| 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication. | |||
| 1.4: Recruit, develop, and retain a competent health care workforce. | 1: Strengthen FDA for Today and Tomorrow | 1.1: Strengthen the scientific foundation of FDA's regulatory mission. | |
| 1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making. | |||
| 1.4: Strengthen FDA's base of operations | |||
| 2: Public health promotion and protection, disease prevention, and emergency preparedness - Prevent and control disease, injury, illness, and disability across the lifespan, and protect the public from infectious, occupational, environmental, and terrorist threats.
|
2.1: Prevent the spread of infectious diseases | 2: Improve Patient and Consumer Safety | 2.2: Improve information systems for problem detection and public communication about product safety. |
| 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products | |||
| 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition. | |||
| 3: Increase Access to New Medical and Food Products | 3.1: Increase the number of safe and effective new medical products available to patients. | ||
| 3.3: Increase access to safe and nutritious new food products. | |||
| 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain | 4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers. | ||
| 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication. | |||
| 2.2: Protect public against injuries and environmental threats | 2: Improve Patient and Consumer Safety | 2.2: Improve information systems for problem detection and public communication about product safety. | |
| 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products | |||
| 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition. | |||
| 2.3: Promote and encourage preventive health care, including mental health, lifelong health behaviors, and recovery. | 2: Improve Patient and Consumer Safety | 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products. | |
| 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition. | |||
| 2.4: Prepare and respond to natural and manmade disasters | 2: Improve Patient and Consumer Safety | 2.2: Improve information systems for problem detection and public communication about product safety. | |
| 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition. | |||
| 3: Increase Access to New Medical and Food Products | 3.1: Increase the number of safe and effective new medical products available to patients. | ||
| 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain | 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication. | ||
| 4: Scientific Research and Development – Advance scientific and biomedical research and development related to health and human services
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4.1: Strengthen the pool of qualified health and behavioral science researchers; | 1: Strengthen FDA for Today and Tomorrow | 1.1: Strengthen the scientific foundation of FDA's regulatory mission. |
| 1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making. | |||
| 4.2: Increase basic scientific knowledge to improve human health and development; | 1: Strengthen FDA for Today and Tomorrow | 1.1: Strengthen the scientific foundation of FDA's regulatory mission. | |
| 1.3: Enhance partnerships and communications. | |||
| 2: Improve Patient and Consumer Safety | 2.1: Strengthen the science that supports product safety | ||
| 3: Increase Access to New Medical and Food Products | 3.1: Increase the number of safe and effective new medical products available to patients. (Critical Path projects) | ||
| 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain | 4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution. | ||
| 4.3: Conduct and oversee applied research to improve health and well-being; | 1: Strengthen FDA for Today and Tomorrow | 1.1: Strengthen the scientific foundation of FDA's regulatory mission. | |
1.3: Enhance partnerships and communications. |
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| 2: Improve Patient and Consumer Safety | 2.1: Strengthen the science that supports product safety | ||
| 3: Increase Access to New Medical and Food Products | 3.2: Improve the medical product review process to increase the predictability and transparency of decisions using the best available science. | ||
| 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain | 4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution | ||
| 4.4: Communicate and transfer research results into clinical, public health, and human service practice. | 1: Strengthen FDA for Today and Tomorrow | 1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensure integrity and accountability in regulatory decision making. | |
| 1.3: Enhance partnerships and communications. | |||
| 2: Improve Patient and Consumer Safety | 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products. |