FDA introduces new Office of Digital Transformation to back its public health mission

U.S – The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT), to better assure the safety of the nation’s food.

The office has been realigned to report directly to the FDA commissioner, buoying up the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission.

The restructuring is a noteworthy step in the FDA’s technology and data modernization efforts that began more than two years back. It allows the FDA to bring more effective and efficient data and IT management, built on best practices, to streamline and advance FDA operations by reducing duplicative processes, implementing technological efficiencies using projects that deliver the most customer benefits, and promoting shared services within agency offices and centers to strategically and securely further the agency’s regulatory mission.

Janet Woodcock, M.D., Acting FDA Commissioner, informed that good data management, built into all of FDA’s work, ultimately helps meet and advance the agency’s mission to ensure safe and effective products for American families. She notified that the agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of its mandate.

“By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”

Since September 2019, the FDA has been undertaking a modernization effort, with the Technology Modernization Action Plan, which laid the groundwork for the more-modern approach to the use of technology for the agency’s regulatory mission, including looking at innovative ways for the review of food safety and other critical functions.

That was followed by the Data Modernization Action Plan, announced earlier this year, which built upon the successful streamlining and process improvements started in 2019 to identify and execute high value driver projects for individual centers and for the agency.

As part of the establishment of this new office, the agency is also announcing the appointment of Vid Desai as the agency’s new Chief Information Officer.

The FDA FY 2022 budget request included funding to support the agency’s data and IT modernization efforts for enterprise-wide data modernization, demonstrating the commitment to and the progress of these institutional changes.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and security of the nation’s food supply.