The Food and Drug Administration recently released Strategic Priorities for 2014-2018, a document that articulates the goals and priorities that will guide the FDA over the next four years. It describes a number of key strategies that the agency will employ as it works to achieve these goals.
The FDA identifies the four key components of its core mission and goals as oversight, access, informed decision-making, and organizational excellence. It also highlights five strategic priorities:
- Regulatory science
- Safety and quality
- Smart regulation
In addition, the agency said it will focus on:
- enhancing oversight of FDA-regulated products;
- improving and safeguarding access to FDA-regulated products;
- promoting better informed decision making about the use of FDA-regulated products; and
- strengthening its organizational excellence and accountability.
The FDA updates its strategic priorities document every four years to ensure that its strategic plan aligns with its annual performance reporting in congressional budget justifications. It sets forth the agency’s plan to streamline and improve its operations to increase transparency and to inform regulatory decision-making in an era of rapid technological advances and cutting-edge technologies.
FDA Strategic Priorities
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, and performance of FDA-regulated products. Regulatory science is essential to advancing the FDA’s core mission of protecting and promoting the public health. Under the umbrella of regulatory science are technological breakthroughs, such as the sequencing of the human genome, groundbreaking new cell and gene therapies, nanotechnology, the development of new genetic, chemical and pharmacological tests, rapid detection systems, and state-of-the-art electronics and materials science to transform medical devices. These and other technological advances enable the FDA to improve the product development process by providing new tools, models and simulations to test medical products, increase the quality and efficiency of clinical trials, and identify and evaluate clinical endpoints and related biomarkers for trials in areas where optimal endpoints are lacking. The agency has identified technological development as a priority; by providing new and innovative tools for review, FDA reviewers can better assess data needs for new products and, thus, better evaluate new products.
As an example of how improvements in regulatory science can apply to daily life, with approximately 48 million Americans experiencing foodborne illness annually, the FDA seeks to develop and validate new rapid detection methods that can be shared with government and industry partners to prevent contamination of the nation’s food supply and improve its ability to identify the cause of foodborne illness outbreaks. With the ever-increasing threat of antimicrobial resistance and the decline of effective antibiotic treatments, it also is promoting the judicious use of medically important antimicrobial drugs in food-producing animals.
The FDA has set forth an aggressive agenda to reduce the public health impact from tobacco products. The agency is currently exploring research study areas to define the diversity of tobacco products; reduce addiction, toxicity, and carcinogenicity of tobacco products; and better define adverse health consequences related to tobacco use.
The FDA regulates products that originate from more than 200 countries and accounts for approximately 20 percent of all U.S. consumer spending. As such, the FDA’s success in protecting the American public relies heavily upon its ability to extend its reach beyond U.S. borders. Through its globalization agenda, the agency plans to strengthen its partnerships with its government regulatory counterparts in other nations, as well as with industry and regional and international organizations, to encourage the implementation of science-based standards that will ensure the safety and quality of products before they reach the U.S.
The agency’s global agenda is founded on four themes: 1) information-sharing; 2) data-driven risk analytics; 3) enhanced intelligence; and 4) the smart allocation of resources through partnerships. In collaboration with its global partners, the FDA is building a foundation of collaborative research, scientific exchange, and training as a basis for regulatory decision-making. Together, they intend to develop a global data information system and network in which regulators across the world can regularly and proactively share real-time information and resources across global markets. Over the next four years, the agency plans to focus its efforts on best practices to more effectively marshal resources, collaborate with partners, improve the processes of standardized reporting and the facilitation of data exchange, and expand upon its capabilities in intelligence gathering and use.
Safety and Quality
The FDA’s core mission is to ensure the safety and quality of FDA-regulated products in the U.S. and promoting and protecting the public’s health. It defines safety and quality as:
1) the practices used to make products; 2) the integrity of the supply chain that delivers these products to their users; and 3) methods for protecting the public, including laboratory sample analyses for select product categories and product safety reporting systems. As part of its four-year strategic plan, the agency will focus on prevention systems that integrate safety and quality into products or systems to prevent problems before they occur. The agency is already working to advance safety and quality across its own operations. For example, it has instituted the Case for Quality Initiative, which is a voluntary compliance improvement pilot project designed to promote medical device quality. In addition, the FDA is continuing to implement a “lifecycle” approach for biologics that will span early-stage development of product through post-market surveillance.
Over the next four years, the FDA intends to employ the concept of “smart regulation.” The agency defines this concept as maintaining its ability to continue its mission to protect the public health and maintain public trust, while at the same time, encouraging innovation. This is a challenge for the agency when coupled with fiscal constraints, increases in global marketing, rapidly evolving technologies, and emerging areas of science. However, the FDA believes that it can accomplish this goal through smart, sound, science-based regulation that imposes the most appropriate regulatory framework while minimizing unnecessary burden.
The FDA has identified fiscal responsibility as one of its major priorities over the next four years. It recognizes the need to stay current with dramatic technological and market-based changes affecting how food, drugs, biologics and medical devices are produced, while continuing to operate under severe budget constraints. The agency plans to focus its efforts on developing and maintaining operating systems that can do more with less, and continue to identify ways to modernize and maximize efficiency within the agency. Under its four-year plan, it will implement programs that will enhance policy and strategy development and streamline operations, and maintain the integrity of programs already in place and encourage innovation.
Along these lines, the Strategic Priorities 2014-2018 establishes a number of targeted objectives designed to overhaul agency operations to help improve agency responses to identified problems, strengthen its detection and surveillance of products in the U.S. and abroad, and reduce the risks involved in the manufacturing, production and distribution of FDA-regulated products. To promote better informed decision-making, the agency will work to strengthen social and behavioral science to help patients, consumers, and professionals make informed decisions about FDA-regulated products, improve patient and provider access to benefit-risk information, and improve safety and health information provided to the public. It will advance its organizational excellence and accountability by recruiting, developing, retaining and strategically managing a world-class workforce, develop systems to improve the overall efficiency and effectiveness of its operations, and invest in an infrastructure that will enhance productivity and capabilities.