FDA’s “All-in” Approach to Enterprise Transformation

By Janet Woodcock, M.D., Principal Deputy Commissioner, and Meredith Chuk, M.D., Senior Medical Advisor, Director, Enterprise Transformation Operation, FDA
Twitter: @US_FDA

The U.S. Food and Drug Administration’s responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment.

In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.

The Enterprise Modernization Action Plan

Now we are introducing the Enterprise Modernization Action Plan (EMAP), which is the next phase of the FDA’s stronger data and technology foundational approach, which began in 2019, with the Technology Modernization Action Plan (TMAP) followed by last year’s Data Modernization Action Plan (DMAP). Our IT and data modernization efforts form a strong foundation for the future, and will continue to evolve: changes at the data and technology levels must be accompanied by improved business operations to achieve our goals. The EMAP describes our plans to shape the FDA’s future by delivering successful cross-agency efforts that optimize common and essential business processes. We will do this work methodically, ensuring we are solving the right problems, with the right team, to produce measurable results. These efforts will improve operational efficiency and the use of data while strengthening the alignment between agency-wide strategic objectives and investments.

The three components of the EMAP are to:

1. Create the Infrastructure to Support Change: The Enterprise Transformation Operation (ETO) team was created within the Office of the Commissioner and strategically reviews enterprise-wide challenges and implements optimized business processes. The ETO is governed by a committee of the agency’s senior leadership charged with prioritizing the most pressing priorities and change opportunities.
2. Develop a Common Operational Approach: The ETO will employ a standardized approach to analyze, recommend, and implement agreed-upon enterprise business programs that solve shared, cross-agency issues by optimizing business processes and use of data across multiple centers and offices.
3. Ensure Strategic Alignment: Improving alignment between agency-wide strategic objectives and program activities will help us effectively manage funding to increase the return on investment and improve operational and employee effectiveness and efficiency.

Work is underway to optimize inspectional activity processes, firm inventory management, and Freedom of Information Act activities. We are building a team of experienced process improvement personnel, analysts, and project managers to work with FDA organizations to analyze and implement high-priority enterprise business solutions. We’ll utilize this initial work and learning and use it to define and deliver scalable frameworks and tools that will enable us to prioritize and drive sustainable process modernization across the agency.

Successful enterprise transformation will ensure that the FDA functions not as a collection of centers and offices but as an integrated agency, getting the most from our talent, technology, and budget. This transformation will be a continual and incremental journey, supported by a change mindset at all levels of the FDA to break down barriers, eliminate silos, and optimize our work. As we move forward, our ongoing commitment to protecting the public health will remain unchanged, and we will work to achieve it in increasingly efficient and sustainable ways.

This article was originally published on FDA Voices and is reprinted here with permission.