Strategic Priorities - Introduction
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The U.S. Food and Drug Administration (FDA) is the agency within the U.S. Department of Health and Human Services (HHS) responsible for ensuring the safety and effectiveness of products that account for about 20 cents of every dollar spent by American consumers each year — products that touch the lives of every American every day. These include human and animal drugs, 80 percent of the food supply, biological products, medical devices, cosmetics, radiation-emitting products, and tobacco products.
Ensuring a safe and nutritious food supply and safe, effective, and innovative medical products requires a strong infrastructure and a dedicated workforce. FDA’s seven product and research centers and two major offices are staffed by more than 12,000 employees
around the world who work together to fulfill FDA’s fundamental public health mission: to protect and promote the health of the American people.
FDA’s primary responsibility is to protect the American people from unsafe or mislabeled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day. The agency also guides and oversees the development and availability of effective new medical products and new food products that harness the latest advances in science and technology to improve the health and well-being of American consumers.
Today, FDA is facing a critical set of public health challenges; challenges brought about by the unique demands of the 21st century. Science and technology are changing our world in dramatic ways; we are seeing an explosion of knowledge and capabilities emerging from many domains of research and from around the globe. In addition, we live in an increasingly globalized world, which has made ensuring the safety of food, drugs, and devices for the American people a global endeavor that integrates products and people across borders. It is clear that today, FDA’s job is fundamentally different — and far more complex — than it was even a few years ago. Although it will not be easy, we will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies; international authorities; academia; non-government organizations; and the private sector.
This document outlines a path toward achieving FDA’s vision for the next five years. We envision a transformed and integrated global food safety system, focused on prevention and improved nutrition. We envision patients and families benefiting from decades of investment in medical science and technology. We also envision a strong field of regulatory science so FDA can ensure the safety and effectiveness of new medical products throughout their life cycles.
We at FDA will use the priorities and goals laid out in this document to improve operating infrastructure, modernize regulatory processes, strengthen our workforce — and, ultimately, better promote and protect the health of the American people.
1.1 Mission and Vision
The mission of HHS is to enhance the health and well-being of Americans by providing effective health and human services and by fostering sound, sustained advances in the sciences needed to promote medicine, public health, and social services.
FDA is charged with protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products.
Specifically, FDA is responsible for advancing the public health by:
· Helping to speed innovations that make foods safer and make medicines and devices safer and more effective;
· Ensuring the public has accurate, science-based information they need to use medicines, devices, and foods to improve their health;
· Regulating the manufacture, marketing, and distribution of tobacco products and reducing tobacco use by minors; and,
· Addressing the Nation’s counterterrorism capability and ensuring the security of the supply of foods and medical products.
FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.
1.2 Purpose of this Document
The purpose of this document is to outline FDA’s strategic intentions and plans for the next five years (2011 – 2015). This document is intended to communicate the Commissioner’s key priorities, including cross-cutting strategic priorities, program-specific strategic goals, and long-term objectives. 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 HHS. Crosswalks that highlight the relationship between FDA and HHS strategic goals and Healthy People 2020 Objectives can be found in Appendix A and Appendix B, respectively.
1.3 Guiding Principles
We are committed to excellence in pursuing our mission and maintaining the public’s trust. In doing so, we adhere to several fundamental guiding principles: science-based decision making, innovation/ collaboration, transparency, and accountability. These principles govern our deliberations, decision making, and actions and provide the framework for our interactions within FDA, with the public, and with other FDA stakeholders. We recognize that effective communication is the foundation for successfully implementing these principles.
FDA has a solemn responsibility to protect and promote the public health. This responsibility requires that FDA base its policies, regulations, and enforcement decisions on sound science. For our decisions to have credibility, we must continue to seek the most current scientific understanding by supporting the work of agency scientists and scientific advisory committees. Strengthening FDA as a public health agency requires a culture that encourages scientific exchange, respects alternative viewpoints along the path of decision making, and protects the integrity of its scientific review processes.
We have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come.
We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system. The Critical Path Initiative (CPI), an agency effort to modernize the sciences for developing, evaluating, manufacturing, and using FDA-regulated products, has long recognized the importance of collaboration to leverage critical expertise and resources in driving scientific innovation. Building on CPI, FDA’s Advancing Regulatory Science Initiative recently established a formal collaboration with the National Institutes of Health to advance regulatory science and build the capacity needed to ensure the safety and effectiveness of innovative new products and technologies.
One of the most pressing FDA-wide goals is promoting transparency in FDA’s operations, activities, processes, and decision making, as well as making information and data available in user-friendly formats while also protecting confidential and proprietary information. Transparency can enhance FDA’s work and — more important — increase the trust and confidence of employees, policymakers, stakeholders, and the public. In response to a Presidential memorandum on transparency and open government, FDA established a Transparency Task Force to develop and implement recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely and user-friendly manner. FDA will continue to engage the public in identifying ways to improve transparency at the agency.
Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the quality and ethical conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK. We understand the importance of FDA’s work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on that responsibility.
Read next section: 2.0 Cross Cutting Priorities