Dive Brief:

• FDA has reorganized its IT, data management and cybersecurity groups into a new office that will report directly to the commissioner.
• The creation of the Office of Digital Transformation (ODT) is part of a push at FDA to bring its use of technology and data in line with modern practices and to cut duplicative processes.
• FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan, which is intended to move the agency away from "antiquated methods" such as manually looking for safety signals in large volumes of PDFs.

Dive Insight:

The establishment of ODT builds on a series of initiatives launched by FDA in recent years. In 2019, FDA released a roadmap for modernizing its computer hardware, software, data and analytics. FDA followed up in March with a plan for modernizing its use of data, leveraging the infrastructure put in place through the technology roadmap.

With both plans in place, FDA requested a significant fiscal 2022 funding bump for its work on data modernization and enhanced technologies. The provision of an extra $75.9 million will bring the total budget up to $82.9 million.

ODT will now take responsibility for driving forward the push to improve IT and data use at FDA. The agency said bringing together its IT, data management and cybersecurity functions and elevating them to agency-level will enable it to "streamline and advance" its operations by reducing "duplicative processes, implementing technological efficiencies ... and promoting shared services within agency offices and centers." 

The budget request for 2022 contains other details of FDA's modernization plans. In the request, FDA said "data-informed capabilities" such as AI and blockchain will be critical to its priorities. The agency is now trying to move away from its older, more manual processes and toward those modern ways of working.  

FDA named Vid Desai as its new chief information officer. Desai, who will be part of the leadership team of the new office, joined FDA in 2019 as chief technology officer, having previously worked at BD spinoff Vyaire Medical. 

The promotion to CIO fills a post that has caused the agency problems for years. Around a decade ago, FDA went through five CIOs in as many years. Then, after a few years when Todd Simpson held down the role, Craig Taylor, Amy Abernethy and finally Desai himself filled the post on an acting basis.