The US Food and Drug Administration (“FDA” or “the agency”) released for public comment on July 1st a draft of its strategic priorities for the next four years. Entitled “Food and Drug Administration Strategic Priorities 2014-2018”, the strategic plan is intended to provide a broad description of how FDA will address the nation’s public health challenges over the next four years.
I. FDA cross-cutting strategic priorities
The agency updates its strategic priorities every four years. A cross-agency workgroup ensures that the plan aligns with FDA’s annual performance reporting in Congressional Budget Justifications. The recently-published draft plan sets forth the agency’s goals and objectives and describes FDA’s approach to its public health mission. The plan also explains the agency’s role in supporting the larger mission and strategic goals of the Health and Human Services Administration.
The four-year-plan describes FDA’s work to address complex, multifaceted, and evolving public health issues, and focuses on five cross-cutting strategic priorities: i) regulatory science, which includes developing new tools, standards, and approaches to assess the safety, efficacy, quality, toxicity, public health impact, or performance of FDA-regulated products; ii) globalization, which addresses the complexities that stem from the fact that FDA-regulated food and medical products, and their ingredients and components, originate from more than 200 countries and territories and pass through more than 300 US. ports; iii) safety and quality, which includes the practices used to make products, the integrity of the supply chain that delivers these products to their users, and methods for protecting the public; iv) smart regulation, meaning smart, sound, science-based regulations that impose the most appropriate regulatory framework while minimizing unnecessary burden; and v) stewardship, which relates to the FDA maximizing public health value from each Federal dollar through effectively and efficiently using limited resources to increase productivity while maintaining program integrity. FDA also identified core mission goals and objectives, each of which is described in more detail below.
II. Goal 1- Enhance oversight of FDA-regulated products
FDA plans to ensure safety, reduce risk, and prevent problems in the global supply chain by continuing to develop standards and guidance for the industry through the following four objectives:
A. Objective 1.1 – Increase the use of regulatory science to inform standards development, analysis, and decision-making.
Over the next four years, FDA plans to increase the use of regulatory science to inform standards development, analysis, and decision-making to improve FDA oversight before and after FDA-regulated products enter the marketplace in order to protect and promote the public health. To this end, FDA will implement strategies focusing on improving the effectiveness of preventive control standards, developing predictive safety models, safety and toxicity signal detection, refinement and validation, as well as comprehensive regulatory approaches for integrating pre- and post-approval and compliance functions.
B. Objective 1.2 – Reduce risks in the manufacturing, production and distribution of FDA-regulated products.
FDA is committed to achieving higher rates of compliance with prevention- and risk-based food and feed safety standards through new enforcement authorities and by holding imported foods to the same standards as domestic foods. FDA will focus on quality and the ability to trace medical products as they are distributed in the US. FDA also is committed to regulating the manufacture, marketing and distribution of tobacco products, especially among youth. The agency will continue to build an integrated national food and feed safety system in partnership with State and local authorities.
C. Objective 1.3 – Strengthen detection and surveillance of problems with FDA-regulated products.
Over the next four years, FDA will continue to implement new authorities and capitalize on advances in regulatory science to strengthen its ability to detect problems with FDA-regulated products. These efforts include the monitoring of internet sales and promotion of FDA-regulated products, laboratory sample analyses for select product categories and product safety reporting systems, as well as bolstering FDA’s post-market surveillance capacities. FDA will continue to work with domestic and international partners to increase information-sharing and enhance collaborations on compliance and training efforts to expand the collective safety net.
D. Objective 1.4 – Improve response to identified and emerging problems with FDA-regulated products.
FDA will use new enforcement tools that Congress has provided to facilitate faster responses to protect public health from foodborne illness outbreaks, emerging infectious disease outbreaks, contaminated drug or biologic products, faulty medical devices, harmful pet foods, natural disasters, or attacks with chemical, biological, radiological or nuclear agents. These tools include the ability to conduct mandatory recalls of unsafe food and feed products; to prohibit food facilities from distributing food that is likely to cause serious adverse health consequences or death; to detain medical products believed to be unsafe and to destroy unsafe or counterfeit products in certain circumstances; to prevent shortages of critically-needed drugs; and to sustain FDA’s comprehensive program to facilitate the development and availability of medical countermeasures.
III. Goal 2- Improve and safeguard access to FDA-regulated products to benefit health
In collaboration with partners in private, public, and academic settings, FDA plans to make advancements in regulatory science to facilitate product development while ensuring that its product review process is effective and efficient through the following three objectives:
A. Objective 2.1 – Increase regulatory science capacity to effectively evaluate products.
FDA plans to ensure that the United States remains a leader in innovation through strategies that include increasing collaboration, training, and information-sharing with the scientific community, industry, and other regulatory bodies; advancing product development tools that can help lead to life-improving and life-saving medicines, and that reduce the time, complexity, and cost of medical product development; and supporting public–private partnerships to advance regulatory science, including the Medical Device Innovation Consortium.
B. Objective 2.2 – Improve the effectiveness of the product development process.
FDA is committed to assisting product developers in translating discoveries in basic science into new therapies. To that end, the agency will continue pursuing initiatives focused on product development, such as the Drug Development Tools Qualification Program, established to develop and standardize biomarkers, and the breakthrough pathway for certain drug products established by the Food and Drug Administration Safety and Innovation Act (FDASIA) that offers fast track designation features. FDA’s strategies include improving the evaluation of methods, tools, models (e.g., animal, physiological, computer-based) that are used in the development and testing of medical products; enhancing communication between FDA and sponsors during the medical product development process; and improving the tools and approaches needed to catalyze the development of personalized medicine.
C. Objective 2.3 – Improve the effectiveness of the product development process.
FDA recognizes that given the limited availability of investment capital for medical product development, early clarification of regulatory requirements is critical. Over the next four years, FDA plans to improve its review efficiency through electronic submission of drug application data; data standardization and data integrity requirements; and by implementing an electronic Managed Review Process. FDA will work to make the review process more transparent and increase productive communication with sponsors by developing proactive communication processes with industry and the public, including consumers of limited English proficiency, on the premarket review process and status of submissions. FDA also plans to increase consideration of health disparities and health outcomes in regulatory decision-making. Finally, the agency plans to continue to improve the substantial equivalence review process for tobacco products, including reducing backlog and time to completion.
IV. Goal 3 – Promote better informed decisions about the use of FDA-regulated products.
FDA plans to work, in collaboration with partners, to determine effective ways to provide better information to the public and to develop outreach and other tools that can assist in better decision-making. Working towards the following three objectives will allow the FDA to reach this goal:
A. Objective 3.1 – Strengthen social and behavioral science to help patients, consumers, and professionals make informed decisions about regulated products.
FDA employs social and behavioral scientists who inform decision-making about communications and other related effects of FDA action. These scientists develop experiments, surveys, and focus groups in order to learn how target audiences respond to FDA communications, and how prospective users approach the use of regulated products.
Over the next four years, FDA will continue to strengthen social and behavioral science by founding the format of major communications on formative research; exploring and testing the integration of qualitative and quantitative social science data with traditional and social media analysis to assess communication effectiveness; analyzing the intersection of economic and behavioral effects of health and safety information; increasing understanding of patients’ and health care providers’ perspectives on benefits and risks; deepening understanding of how health care providers regard regulated products; and supporting research to validate health benefits resulting from consumer dietary changes.
B. Objective 3.2 – Improve patient and provider access to benefit-risk information about FDA-regulated products.
FDA intends to strengthen its risk management efforts to address the injuries of patients taking one of the over three billion prescriptions that are written annually in the US. These patients “suffer unnecessary injuries” and some “die as a result of preventable errors.” FDA cites the Safe Use Initiative, which was created to reduce preventable harm by identifying specific, preventable medication risks and by developing and implementing interventions to minimize the risk of the same.
FDA will continue to explore ways in which such risks can be minimized by enhancing patient access to prescription medication benefit and risk information; using and monitoring social media, e-mail, and web sites to disseminate FDA risk communication alerts and safety information to stakeholders; ensuring public awareness of medical product quality issues; better integrating Risk Evaluation Mitigation Strategy into the health care system; and improving tools used for prescriber-to-patient counseling.
C. Objective 3.3 – Improve safety and health information provided to the public.
FDA is committed to supporting public health through promoting healthful dietary practices and providing the public with accurate information about tobacco products. In its four-year plan, FDA recognizes its responsibility to provide consumers with informative food labeling, so that the public can use this information to make healthier choices about the food that they eat. This, in turn, could help reduce the risk of chronic disease and facilitate health. FDA also recognizes its responsibility to provide the American public with factual and accurate information about tobacco products. FDA will continue to provide the public with information on the harmful ingredients in tobacco and tobacco smoke in ways that are understandable and not misleading.
FDA plans to implement various strategies to reach these goals, including: improving consumer access to and use of accurate nutrition information; implementing sustained public education campaigns on the harms of tobacco products; expanding use of social media, the FDA web site, and the FDA’s Consumer Updates to communicate safety and health information; providing accurate information to consumers so that they can choose a healthier diet; and conducting effective risk communications related to outbreaks and contamination incidents.
V. Goal 4 – Strengthen organizational excellence and accountability
FDA is committed to maintaining organizational excellence and accountability, even while the Agencies’ responsibilities increase and resources remain limited. Working towards the following three objectives will allow the FDA to reach this goal:
A. Objective 4.1: Recruit, develop, retain, and strategically manage a world-class workforce
FDA recognizes its responsibility to attract employee talent that will best allow the agency to respond to emerging challenges presented by today’s complex and globalized regulatory environment. FDA is committed to building a diverse, highly-competent work force. FDA will work to provide its employees with additional training opportunities, including leadership development, career management, and succession planning, in order to best cultivate employees’ talent and skills.
Over the next four years, FDA will continue to make progress by hiring and retaining highly-qualified talent; tracking development and advancement of science and research expertise in the internal workforce; developing mechanisms to promote cross-disciplinary training and research; promoting diversity; and improving opportunities for continuous learning, career development, and work-life balance.
B. Objective 4.2: Improve the overall operation and effectiveness of FDA
FDA is committed to improving the agencies’ operational effectiveness and efficiency. FDA plans to improve operations through collaboration with stakeholders, advisory groups (such as the FDA Science Board), and FDA program members.
FDA plans to implement various strategies to reach this goal, including strengthening leadership and partnership to support public health decision-making; improving management and program effectiveness; continuing the development and implementation of quality review activities; establishing an internal structure that enhances risk-based decision-making; implementing robust compliance strategies; and defining and implanting distinct commodity based (e.g., drugs, medical devices, foods, etc.) regulatory programs with coherent policy and strategy development.
C. Objective 4.3: Invest in infrastructure to enhance productivity and capabilities
FDA’s final objective, meant to strengthen organizational excellence and accountability, is to invest in both IT and real estate infrastructure to better support the agency’s goals and mission. FDA is finalizing an ambitious IT migration, which will enhance the agency’s technical ability, while also protecting systems from security and privacy threats.
FDA will continue to explore ways in which infrastructure can be enhanced by building facilities that meet the demands of the agency’s scientific mission; implementing an IT modernization program; developing and improving on methods used to share data within and outside of FDA; working towards more efficient and cost-effective procurement; securing mission-critical and sensitive assets and information.
FDA states that its draft lays out strategic priorities and goals for keeping patients and consumers safe, as well as addressing industry concerns, at a very high level and in a very broad manner. Improving communication, and increasing efficiency, accountability, and regulatory effectiveness are themes throughout the released draft, but it is unclear what the practical effects on the industry will be as the FDA implements the identified strategies.
Comments are due on this public draft by July 31, 2014. Comments can be made online atwww.regulations.gov, using docket number FDA- 2014-N-0833.