On Thursday, August 4, 2022, The U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner, Janet Woodcock, Ph.D., joined the Alliance for a Stronger FDA for a webinar presentation on FDA’s data and information processing modernization efforts. Dr. Woodcock explained and provided updates on FDA’s 2019 Technology Modernization Action Plan, 2021 Data Modernization Action Plan, and 2022 Enterprise Modernization Action Plan. She also gave insight into how each of FDA’s action plans—individually and combined—contribute to better and more efficient decision-making by FDA.
Dr. Woodcock began by laying out the modernization “problem” that FDA is trying to solve. She stated that “FDA is in the business of information,” in that FDA collects, analyzes, and disseminates data that the agency uses to make regulatory decisions. However, the agency faces many barriers to its modernization and data goals, beginning with FDA’s historically fragmented approach to process development and information technology (IT) investments. According to Dr. Woodcock, many of FDA’s program-based systems are not interoperable within the agency. This has led to an absence of data standards and reliance on manual search. Dr. Woodcock also stated that much of FDA’s supporting software is nearing obsolescence.