Summary of Alliance's Webinar with Dr. Janet Woodcock on FDA Data and Technology Modernization

Over the last 3 years, FDA has developed and issued three plans for modernization of FDA’s infrastructure. Since then, there have been multiple statements of support for these efforts: FDA has allocated part of its Budget Requests to fund this need (page 13 (here); the Alliance’s testimony to the appropriations committees has included a request for funding (House and Senate); and Congress has indicated interest in infrastructure modernization at FDA (here).

On August 4, 2022, the Alliance for a Stronger FDA held a webinar with Dr. Janet Woodcock, Principal Deputy Commissioner of the Food and Drug Administration (FDA). During this event, Dr. Woodcock addressed the current state of knowledge management at FDA, the challenges with existing systems, and several ways that the FDA is centralizing and upgrading such systems. Dr. Woodcock warned that modernization would be a long process but will produce significant benefits for FDA’s efficiency, transparency, and decision-making processes.

The FDA requires a lot of information to inform decisions regarding approvals, inspections, guidances, and more. However, that information has historically been based in fragmented, decentralized business processes and IT systems developed in-house for individual Centers. Dr. Woodcock explained that these in-house systems are not interoperable and the information they contain is often inaccessible from other platforms and incapable of incorporating data from other sources. These systems are also on end-of-life or end-of-support software with increasing cybersecurity risks.

Dr. Woodcock went on to detail several issues that arise from outdated systems. She identified the first issue as an overall waste of time and resources. She described staff completing manual searches from various sources to inform their decision-making and manual hand-offs of inspection requests.

Dr. Woodcock also explained that the lack of data modernization impacted FDA’s effectiveness and efficiency, making it more likely for staff to make inconsistent decisions based on partial information.

Finally, Dr. Woodcock pointed out that staff struggled with providing transparency given that there is no “single source” of information across the Agency to clarify decisions.

In the second portion of her presentation, Dr. Woodcock outlined the FDA’s efforts to create an enterprise system that allows Centers to create product-specific processes but maintain standardization and integration across the system. The process started with the Enterprise Transformation Operation group. which produced three action plans: the Technology Modernization Action Plan released in 2019, the Data Modernization Action Plan released in 2021, and the Enterprise Modernization Action Plan released in 2022.

In addition, the ETO group has developed several pilot programs, including an inspection pilot program with the Center for Food Safety and Nutrition (CFSAN) and the Center for Drug Evaluation and Research (CDER), a pilot master data management system, and a FOIA process optimization program.

Dr. Woodcock said FDA had prioritized modernizing major processes across the agency first, such as inspections and mass data management projects. After the conclusion of the pilots, she hoped that the program will have money to expand ETO and its operations to include other features in the workflow platforms.

In response to a question, Dr. Woodcock said that the best way to ensure that FDA has the money it needs for modernization efforts is via budget authority (BA) appropriations specifically directed to the Enterprise Technology Office and the FDA Capital Working Fund.

Dr. Woodcock concluded the webinar by emphasizing that improved technology and data management would improve efficiency and make better decision-making at FDA. With such a broad mission to support the public health and safety of all Americans, she said the agency needs an efficient infrastructure to do its critical work.