FDA Outlines Strategic PrioritiesBy
The US Food and Drug Administration (FDA) issued a draft plan for its strategic priorities through fiscal year (FY) 2018 and highlighted five cross-cutting goals: regulatory science, globalization, safety and quality, smart regulation, and stewardship. With respect to manufacturing, further advancing quality-by-design, increasing access, sharing ,and use of global data to aid in risk assessment, and encouraging innovation in manufacturing technologies are among the agency’s goals.
Every four years, the US Food and Drug Administration (FDA) updates its strategic priorities document, which describes its work to address complex, multifaceted, and evolving public health issues. For its plan for fiscal years (FY) 2014 through 2018, the agency is emphasizing five cross-cutting areas: regulatory science, globalization, safety and quality, smart regulation, and stewardship in achieving the agency’s goals. The agency is seeking changes long in the making, such as the modernization of its information technology (IT) infrastructure, but also specific goals in manufacturing that can contribute to increased product quality and risk mitigation. The FDA issued its draft plan earlier this month and is seeking public comment.
Each of the FDA’s product and research centers and major offices contributed to the plan’s goals, objectives, and strategies. A workgroup with cross-agency representation ensured that the strategic plan aligns with the FDA’s annual performance reporting in Congressional budget justifications. The plan’s goals and objectives describe the approach for focusing the FDA’s efforts to achieve its public health mission and to fulfill its role in supporting the larger mission and strategic goals of the US Department of Health and Human Services. The FDA will implement these strategic priorities through a tiered planning framework. The FDA senior leadership will integrate them into the annual budget priority setting and formulation processes and implementation planning. At the program level, each FDA product center and major office will implement program-specific actions and monitor key metrics for progress toward achieving its stated strategic objectives and strategies.
Setting the goals
|The FDA points to its statutory mandates in the FDA Safety and Innovation Act and the Drug Quality and Security Act that necessitate that industry and FDA
re-think traditional approaches to safety and quality.
FDA has set four major goals: enhancing oversight of FDA-regulated products; improving and safeguarding access to FDA-regulated products to benefit health; promoting better informed decisions about the use of FDA-regulated products; and strengthening organizational excellence and accountability. In achieving those goals, the agency is emphasizing five cross-cutting areas: regulatory science, globalization, safety and quality, smart regulation, and stewardship, which are further detailed below.
Regulatory science: With respect to its plan for advancing regulatory science, the FDA developed a Strategic Plan for Regulatory Science that identified plans to close critical gaps in scientific knowledge required to support regulatory decision-making. By closing these gaps, FDA’s regulatory science program facilitates translation of new technologies and basic science discoveries into real-world diagnostics, treatments, and cures. The agency points out that addressing regulatory-science needs can improve the product development process by using new tools, models, and simulations to test medical products, increasing the quality and efficiency of clinical trials, and identifying and evaluating clinical endpoints and related biomarkers for trials in areas where optimal endpoints are lacking. Similarly, by providing new and innovative tools for review, regulatory science will help FDA reviewers better assess data needs for new products and thus better evaluate new products, noted FDA in its report.
Globalization: FDA is working with partners to enhance responsibility for and oversight of safety and quality throughout the supply chain. In the draft report, FDA said it is developing an international operating model consisting of four pillars: information sharing, data-driven risk analytics, enhanced intelligence, and the smart allocation of resources through partnerships. In its draft report, FDA identified its current work in building close partnerships with its foreign counterparts, such as the Global Coalition of Regulatory Science Research, which is building a foundation of collaborative research, scientific exchange, and training as a basis for regulatory decision-making. With these coalitions, the FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets. Efforts include working with partners to identify critical data elements, such as unique facility identifiers, to better standardize reporting and facilitate data exchanges. The agency said it will continue to expand its capabilities in intelligence-gathering and use with an increased focus on risk analytics and modernized IT capabilities and to more effectively allocate its resources based on risk.
Safety and science: Safety and quality include three main areas: the practices used to make products; the integrity of the supply chain that delivers these products to their users; and the methods for protecting the public, including laboratory sample analyses for select product categories and product-safety reporting systems. The agency points to statutory mandates of the agency set forth in the FDA Safety and Innovation Act (FDASIA) and the Drug Quality and Security Act (DQSA) that necessitate that industry and FDA re-think traditional approaches to safety and quality, which involves addressing safety and quality through policies, practices, and standards, domestically and internationally to reduce risks in the manufacturing, production, and distribution of FDA-regulated products. The agency points out that this requires top-level management commitment; a clear and in-depth knowledge of the product and the system; supply-chain management throughout the entire life of a product; proactive and continuous management of risk; and continuous and consistent monitoring of quality management systems and processes.
|By “smart regulation,” the FDA says it can attain the goal of protecting public
health while encouraging innovation.
Smart regulation: By “smart regulation,” FDA says it can attain the goal of protecting public health while encouraging innovation. “That is, the goal can be reached through smart, sound, science-based regulation that imposes the most appropriate regulatory framework while minimizing unnecessary burden,” said FDA in its report. To that end, FDA said that smart regulation provides a pathway toward meaningful innovation, instills consumer confidence in products and treatments, levels the playing field for businesses, decreases the threat of litigation, and prevent recalls that threaten industry reputation and consumer trust. In its report, FDA points to statutory mechanisms enabled through FDASIA and DQSA to enable that process. FDASIA, for example, authorizes FDA to collect user fees from the industry to fund reviews for medical devices, innovative new human prescription drugs, human generic drugs and biosimilar biological products. It also provides new authorities for drug shortages, supply-chain safety, device review modernization, and other provisions. The new provisions in the DQSA enhance FDA’s ability to reduce the risks associated with drug compounding and the risks of counterfeit and other potentially harmful products from entering the drug-distribution supply chain.
Stewardship: In its draft report, FDA emphasized its obligation to effectively and efficiently use limited resources to increase productivity while maintaining program integrity. FDA said it will continue to prioritize recruiting, developing, and retaining a high-quality workforce, seek operational excellence and accountability from its programs, and foster a culture of collaboration and continuous improvement. FDA said it is improving systems and processes for hiring, compensating, training, assessing, and retaining staff.
Identifying specific initiatives
These cross-cutting goals of regulatory science, globalization, safety and quality, smart regulation, and stewardship are embedded in the agency’s four main goals: enhancing oversight of FDA-regulated products; improving and safeguarding access to FDA-regulated products to benefit health; promoting better informed decisions about the use of FDA-regulated products; and strengthening organizational excellence and accountability. Within these four goals, the FDA outlined further objectives to fulfill its strategy as described below.
Enhancing oversight of FDA-regulated products: In enhancing its oversight of FDA-regulated products, FDA said it will focus on the following: increasing the use of regulatory science to inform standards development, analysis, and decision-making; reducing risks in manufacturing, production, and distribution; strengthening detection and surveillance of problems with FDA-regulated products; and improving response to identified and emerging problems.
In its draft report, the FDA outlined specifics in reaching these goals. Over the next four years, the FDA said it will 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. To this end, the FDA will implement the following strategies: evaluate and improve the effectiveness of preventive control standards; advance the development of predictive safety models; assess and encourage development of new technologies to enable rapid, sensitive, specific, and high-throughput testing; develop and assess methods to improve safety and toxicity signal detection, refinement, and validation; develop comprehensive regulatory approaches for integrating pre- and post-approval and compliance functions.
FDA said it will continue to encourage quality-focused efforts, such as quality by design. The agency said it will increase government and industry knowledge and understanding of FDA science-based practices and new approaches to safety and quality and increase access, sharing, and use of global data from foreign, federal, state, local, and private sources to aid in the assessment of risks related to FDA-regulated products. It also said it will promote manufacturing strategies that improve manufacturers’ ability to maintain a consistent product and increase the integration of cutting-edge scientific technologies and methods into regulatory oversight and guidance to industry. The agency said it will collaborate with regulatory counterparts to leverage resources and avoid duplication of inspections as well as build a model for mutual reliance by sharing inspection reports. It also said it will improve risk-based approaches to conducting inspections. FDA also said it will enhance its ability to prevent and respond to drug shortages
Improving and safeguarding access to FDA-regulated products to benefit health: As part of its overall goal to improve and safeguard access to FDA-regulated products, the FDA said it will increase regulatory-science capacity to effectively evaluate products, improve the effectiveness of the product-development process, and improve predictability, consistency, transparency, and efficiency of the review process. To that end, some key specific goals include: increasing collaboration, training, and information-sharing with the scientific community, industry, and other regulatory bodies; advancing product development tools that reduce the time, complexity, and cost of medical product development; and strengthening its infrastructure to support high quality and state-of-the-art scientific investigations.
As part of its goal of advancing product development, FDA said it will advance the development of medical products for rare diseases, enhance communication between the FDA and sponsors during the medical product development process, facilitate the application of advanced technologies and methods and relevant scientific discoveries—such as newly identified clinical biomarkers, adaptive clinical trial designs and genomics—to regulated medical products and improve the tools and approaches needed to catalyze the development of personalized medicines.
As part of its goal of improving predictability, consistency, transparency, and efficiency of the review process, the agency said it will: improve review efficiency through electronic submission of drug application data; implement an electronic Managed Review Process (eMRP) to promote efficient review of products; improve review efficiency through data-standardization and data-integrity requirements; and increase consideration of health disparities and health outcomes in regulatory decision-making.
Promoting better informed decisions about the use of FDA-regulated products: Over the next four years, the FDA said it will pursue three objectives to promote better informed decisions about the use of FDA-regulated products: strengthen social and behavioral science to help patients, consumers, and professionals make informed decisions about regulated products; improve patient and provider access to benefit-risk information about FDA-regulated products; and improve safety and health information provided to the public.
Strengthening organizational excellence and accountability: Over the next four years, the FDA said it will pursue three objectives to strengthen organizational excellence and accountability: recruit, develop, retain, and strategically manage a world-class workforce; improve the overall operation and effectiveness of the FDA; and invest in infrastructure to enhance productivity and capabilities. To that end, FDA has highlighted some specific goals: strengthen scientific leadership, capacity, and partnership to support public health and animal health decision-making; improve management and program effectiveness and make optimal use of FDA program resources; continue the development and implementation of quality approaches for review activities and other key center operations; develop and implement an evidence-based resource planning model that connects performance measures and outputs to public health outcomes; establish a process and management structure to enhance risk-based decision-making; provide IT tools to enable collaboration; implement robust compliance, internal control, and risk-management strategies; implement enhanced modernized management systems; and define and implement distinct commodity-based (e.g., drugs, medical devices, foods) and vertically integrated regulatory programs with well-defined leads, coherent policy, and strategy development and a delayered management structure.
The FDA also has specified goals to improve its IT infrastructure and data-sharing abilities. Over the next four years, it has set a goal to implement an IT modernization program to provide integrated information and shared data resources and develop or improve on methods to share data and informatics approaches within and outside of the FDA.
The full draft report, Food and Drug Administration Strategic Priorities 2014-2018 may be found here.
See related story, “FDA Begins Implementation Efforts for Drug Supply Chain Security Act“