By Janet Woodcock, M.D., Acting Commissioner of Food and Drugs, FDA
Twitter: @US_FDA
The U.S. Food and Drug Administration’s mission to protect and promote the public health impacts the life of every American, every day. Our work encompasses an ever-widening array of foods, additives, cosmetics, medicines, and medical devices as the FDA regulates approximately 20 cents of every dollar spent annually by American consumers. The industries we regulate are constantly innovating, attracting skilled professionals, and upgrading their technological capabilities. The FDA must keep pace. FDA’s FY 2022 budget requests an increase of $185 million to embark on an effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce, and improve our scientific capability and regulatory structure.
Scientific breakthroughs have enabled the development of new, more personalized therapeutic treatments, advanced manufacturing, and modern data solutions such as blockchain, genomic information, and real-time analytics. As a byproduct of these exciting advancements, the amount and variety of data that the FDA generates, needs, and uses is rapidly increasing. But we are often hampered by antiquated methods, including inspecting large volumes of PDFs, often “by hand,” in order to identify critical safety signals, such as human and animal drug and device safety concerns or emerging foodborne outbreaks.
The FY 2022 Budget includes $82.9 million — an increase of $75.9 million above the FY 2021 enacted level — for an agency-wide data modernization and enhanced technologies initiative that supports both food safety and medical product safety programs. The initiative includes two components: enterprise technology and data across the foods and medical product programs, and four complementary program-specific investments. These investments will modernize our data infrastructure by using current technology innovations that allow us to more efficiently gather data; identify, analyze, and respond to potential problems more quickly; and further improve review times for medical products.
Enterprise Modernization Addresses Agency-wide Business Issues
Historically, the FDA has taken a center-based approach to IT investments, resulting in siloed solutions and a fragmented data environment. The enterprise technology and data request of $44.5 million in total will support an agency-wide enterprise modernization effort to strengthen the common data infrastructure and allow us to take a collaborative, centralized approach to modernizing our technical IT infrastructure and the way we manage data across the FDA.
Changes at the data and technology level go hand-in-hand with a modern and optimized business process. The enterprise modernization plan will provide a mechanism to fund and sustain agency-wide enterprise programs, and also deliver improved value and return on investments associated with addressing business issues common across all centers by avoiding duplication and encouraging sharing of existing capabilities.
Enterprise modernization is critical to our success as an agency, and the FDA FY 2022 Budget will directly support our efforts to evolve and modernize the agency’s mission, workforce, and operations.
Putting Data to Work for Public Health
Data have always formed the basis of the FDA’s science-based regulatory decision making. These data may come from relatively traditional sources — for example, measurements submitted to the FDA from clinical trials or observations from FDA field inspections. As technology has become more sophisticated and our world has become more connected, data from new sources are helping us understand, for example, how medical products are performing or how we can pinpoint the source of a foodborne illness.
Further, when the FDA applies more advanced technologies to its work, the agency can help facilitate innovative development of FDA-regulated products and new methods of generating and analyzing data to evaluate whether those products meet the FDA’s standards that patients depend upon. To do this, the FDA must also invest in its own regulatory programs to keep pace with the tremendous changes taking place in how human and animal medical products are being developed and produced so that we can help ensure their responsible development.
- The FY 2022 Budget includes $52 million — an increase of $44.8 million above the FY 2021 enacted level — for the New Era of Smarter Food Safety, of which the Data Modernization and Enhanced Technologies investment provides $22.8 million for essential work for food safety that aligns with the Blueprint for a New Era of Smarter Food Safety, as well as the agency’s technology modernization plans. The goal of the Smarter Food Safety initiative is to help reduce the number of foodborne illnesses in the U.S. and protect consumers from other food safety hazards.
- The Budget includes an additional $10.7 million above the FY 2021 enacted level for the Center for Veterinary Medicine (CVM) to modernize outdated and disparate IT systems and business processes that are currently founded on the digitalization of paper-based processes. The American public and regulated industry rely on CVM to evaluate the safety and effectiveness of animal drugs and to review animal food ingredients to help keep animals healthy, while also helping to ensure that the meat, milk, and eggs from food-producing animals are safe for people to eat.
- The Budget also includes an increase of $0.9 million above the FY 2021 enacted level to support the Center for Biologics Evaluation and Research’s capabilities through improved information management and data infrastructure. This is critical to managing and reviewing the increased number of novel and scientifically complex biological products, including those to prevent and treat emerging and changing infectious diseases, such as COVID-19.
- Finally, the Budget includes an additional $2.8 million above the FY 2021 enacted level, for a total of $40.8 million, to support additional technical capabilities for the Devices Program’s Digital Transformation initiative. Timely patient and consumer access to new, safe, innovative devices and continued safeguards depend on modernized IT systems. The Center for Devices and Radiological Health’s Digital Transformation will further enable the Devices Program to integrate, redesign, and streamline at least 80 percent of its core business processes. This could generate cost savings, improve the FDA’s ability to more quickly identify and address safety signals, and spur the development of safer, more effective devices.
By consolidating data systems and migrating to a reliable hybrid cloud environment, the FDA can move closer to the speed of industry in streamlining workflows, reducing the cost of maintaining data and network security, and improving the timeliness of delivery of services.
We will update the public on other key FDA budget priorities in future FDA Voices, and look forward to continuing to work with Congress to ensure the FDA has the resources it needs to carry out our vital public health mission to protect and promote the public health.
This article was originally published on FDA Voices and is reprinted here with permission.