The U.S. 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), and has appointed Vid Desai as its new Chief Information Officer.

The office has been realigned to report directly to the FDA commissioner, elevating 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.

“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” says acting FDA commissioner Janet Woodcock, MD.  

The reorganization is a significant step in the FDA’s technology and data modernization efforts that began more than two years ago. The move 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. The agency will now be able to implement technological efficiencies using projects that deliver the most customer benefits, while promoting shared services within agency offices. Finally, the agency can strategically and securely further its regulatory mission.

 “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 what we do,” Woodcock says.  

The FDA has been undertaking a modernization effort since September 2019. It began with the Technology Modernization Action Plan, which laid the groundwork for the more-modern approach to using technology for the agency’s regulatory mission. The plan called for looking at innovative ways of reviewing medical product applications, food safety and other critical functions. Then earlier this year, the FDA announced the Data Modernization Action Plan, which built on the successful streamlining and process improvements of 2019, to identify and execute high value driver projects for individual centers and for the agency.

“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, drugs, medical devices and other products that the FDA regulates in this complex world,” Woodcock says. “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.”