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FDA Science Moving Forward — Progress Report to the FDA Science Board’S Science Looking Forward Subcommittee

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FDA Science Moving Forward — Progress Report to the FDA Science Board’S Science Looking Forward Subcommittee FDA Science Moving Forward — Progress Report to the FDA Science Board’s Science Looking Forward Subcommittee FDA MISSION STATEMENT ..................................................................................................................................... 1 EXECUTIVE SUMMARY ........................................................................................................................................... 2 INTRODUCTION ..................................................................................................................................................... 3 BACKGROUND ............................................................................................................................................................... 3 FDA’S UNIQUE AND CRITICAL ROLE IN ADVANCING REGULATORY SCIENCE................................................................................ 4 SECTION A. BUILD A STRONG FOUNDATION FOR REGULATORY SCIENCE ....................................................... 7 1. PROVIDE STRATEGIC LEADERSHIP AND VISION FOR REGULATORY SCIENCE ......................................................................... 9 2. ESTABLISH REGULATORY SCIENCE PRIORITIES .............................................................................................................. 9 3. OPTIMIZE ORGANIZATION, GOVERNANCE, AND REVIEW .............................................................................................. 12 4. ENHANCE RESOURCES AND INFRASTRUCTURE ............................................................................................................ 17 5. DEVELOP NEW MECHANISMS AND PROGRAMS TO LEVERAGE EXTERNAL EXPERTISE .......................................................... 20 SECTION B. STRENGTHEN AND LEVERAGE HUMAN & CAPITAL RESOURCES ......................................................... 23 1. SECURE CRITICAL SCIENTIFIC CAPABILITY AND CAPACITY .............................................................................................. 23 2. RECRUIT TOP SCIENTIFIC TALENT TO FDA ................................................................................................................ 23 3. ENHANCE FDA SCIENTIFIC TRAINING AND CONTINUING EDUCATION OPPORTUNITIES ....................................................... 25 4. PROMOTE A CULTURE OF SCIENTIFIC EXCELLENCE: PEER REVIEW AND RECOGNITION ........................................................ 27 5. BUILD INTRAMURAL COLLABORATIONS .................................................................................................................... 27 6. LEVERAGE EXTERNAL CAPABILITIES TO ADVANCE REGULATORY SCIENCE ......................................................................... 28 SECTION C. DEMONSTRATE REGULATORY SCIENCE ACHIEVEMENTS ................................................................... 37 1. MODERNIZE TOXICOLOGY TO ENHANCE PRODUCT SAFETY ........................................................................................... 37 2. STIMULATE INNOVATION IN CLINICAL EVALUATIONS AND PRECISION MEDICINE TO IMPROVE PRODUCT DEVELOPMENT AND PATIENT OUTCOMES ............................................................................................................................................ 42 3. SUPPORT NEW APPROACHES TO IMPROVE PRODUCT MANUFACTURING AND QUALITY ..................................................... 47 4. ENSURE FDA’S READINESS TO EVALUATE INNOVATIVE EMERGING TECHNOLOGIES ........................................................... 51 5. HARNESS DIVERSE DATA THROUGH INFORMATION SCIENCES TO IMPROVE HEALTH OUTCOMES .......................................... 56 6. IMPLEMENT A NEW PREVENTION-FOCUSED FOOD SAFETY SYSTEM TO PROTECT PUBLIC HEALTH ........................................ 61 7. FACILITATE DEVELOPMENT OF MEDICAL COUNTERMEASURES TO PROTECT AGAINST THREATS TO U.S. AND GLOBAL HEALTH AND SECURITY ........................................................................................................................................................... 67 8. STRENGTHEN SOCIAL AND BEHAVIORAL SCIENCE TO HELP CONSUMERS AND PROFESSIONALS MAKE INFORMED DECISIONS ABOUT REGULATED PRODUCTS .............................................................................................................................. 72 FDA Mission Statement FDA is responsible for protecting the public health by ensuring 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. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. 1 Executive Summary As the Science Board’s 2007 report FDA Science and Mission at Risk anticipated, rapid developments in scientific areas such as genomics, systems-based biology, precision medicine (also known as personalized medicine), informatics, and tissue- and stem cell-based therapy have dramatically increased the complexity of the scientific challenges facing FDA. Furthermore, recent legislation has set new standards, granted new authorities, and established ambitious goals for the Agency. For example, the FDA Amendments Act of 2007 called for the establishment of the Office of the Chief Scientist to provide FDA with strategic vision and leadership for our regulatory science programs and support in identifying our scientific priorities. The establishment of the Office was only one of many far-reaching organizational changes FDA has made since the Science Board’s report. For example, FDA established: • the Office of Counterterrorism and Emerging Threats to facilitate medical countermeasures development and advance regulatory science within this area. • the Office of Scientific Professional Development to provide leadership and support for recruiting and fostering top talent and providing innovative skills development programs to prepare FDA staff to address new regulatory challenges. • the Office of Regulatory Science and Innovation to lead and support the Agency in fostering the creation and use of innovative technologies in product development and evaluation. • the Office of Foods and Veterinary Medicine to lead a functionally unified Foods Program and enhance FDA’s ability to meet today's great challenges and opportunities in food and feed safety as well as nutrition. FDA has implemented many of the Science Board’s recommendations for improving the scientific infrastructure, management, and application of regulatory science to enhance our regulatory mission. At the same time, FDA has expanded its use of existing mechanisms to develop new collaborative programs. This report details how FDA has accelerated efforts to develop new approaches to engaging in synergistic collaborations both intramurally and with other government agencies, academia, industry, patient organizations, professional societies, and other stakeholders. We discuss our efforts to attract, develop, and retain top scientific talent to the Agency and to enhance scientific training and continuing education opportunities for FDA staff. In the final section of our report, we highlight examples of FDA scientific accomplishments, organized according to the eight priority areas that FDA identified in its Strategic Plan. We hope that this report is helpful to the Science Board in its review of FDA’s efforts to advance regulatory science. 2 Introduction Background From its origins as a small office in the Department of Agriculture’s Bureau of Chemistry a little more than a century ago, the Food and Drug Administration (FDA) has grown to an agency that is responsible for overseeing more than $2 trillion in medical products, food, and other consumer products.1 Globalization, emerging technologies, and rapid advances in the sciences that underlie FDA-regulated products have transformed FDA’s regulatory landscape and expanded the scope of our mission. In this changing environment, as FDA monitors the nation’s food supply, drugs, biologics, devices and tobacco products it is critical that we stay abreast of these advances in science and technology. Active engagement with our public- and private-sector partners will help us leverage our scientific resources to ensure that safe, innovative treatments and cures get to the people who need them when they need them. Since its establishment in 1992, FDA’s Science Board has provided us with input on these emerging scientific and technical developments and how best to prepare for their impact. The Science Board’s 2007 report FDA Science and Mission at Risk appropriately emphasized that rapid developments in scientific areas such as genomics, systems-based biology, precision medicine, informatics, and tissue- and stem cell-based therapy would increase the complexity of FDA’s work. Since that report, many of these technologies have entered FDA’s regulatory portfolio, a
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