Remarks by Dr. Amy Abernethy at the Alameda Ribbon Cutting Ceremony September 4, 2019

Speech | In Person

• Speech by: Amy Abernethy, MD, PhD. ; Principal Deputy Commissioner - Office of the Commissioner

Remarks by Dr. Amy Abernethy,

Principal Deputy Commissioner and Acting Chief Information Officer, FDA
Alameda Ribbon Cutting Ceremony

San Francisco, CA
September 4, 2019

I am honored to be here in Alameda with you to commemorate this important step in the evolution of FDA’s regulatory operations. To the staff at FDA—both those that work here in Alameda and those that have worked on this important project from around the country—thank you for all you do in service to protect the public health. Regional Administrator Scott, we appreciate all that you and your colleagues at GSA do to support our Agency’s work. Mayor Ashcraft, thank you for hosting us in the beautiful city of Alameda. Our new District Office and Lab facility represents a new chapter for FDA’s presence here in the Bay Area.

I’ll return to the lab in a moment, but first I want to acknowledge the significance of the new District Office.  The office houses Office of Regulatory Affairs staff from all programs, including the Office of Human and Animal Foods Operations West Division 5, import personnel from the Division of West Coast Imports, and staff from the Office of Medical Products and Tobacco Operations. 

The FDA personnel in this office have enormous geographic responsibilities—from here in California to locations in the South Pacific covering all FDA-regulated products. 

The opening of this new facility is also a testament to the critical partnerships FDA has with state and local governments by providing space where we can train and promote best practices collaboratively with regulatory staff from our partner agencies.  The scientific and regulatory work that our personnel perform here with dedication and integrity is essential to FDA’s ability to meet its mission and protect the public health. 

With protecting public health as our mission, one of our jobs as an Agency is to always ask the question: how can we perform our mission as effectively and efficiently as possible?  This is a hard question, but the answer lies in FDA’s commitment to make regulatory decisions based on sound science and data. We constantly look at better ways to collect and analyze the data that can help FDA make crucial and often time-sensitive decisions. Our laboratories, including the San Francisco laboratory, are crucial generators of data—the “electricity” if you will—that can be harnessed to drive science-based policymaking and regulatory activities. And the analytical technologies that will be used every day at this new laboratory are giving FDA personnel new capabilities and infrastructure to perform their crucial public health mission. 

The move to the new laboratory will provide even more efficiency and flexibility for our analytical teams to handle emergencies, conduct surveillance, and develop new methods.  The lab will provide modern new facilities to analyze food for the presence of bacteria, viruses and parasites that could be harmful to consumers.  FDA scientists will be able to process samples of food and other products and to detect dangerous components, like heavy metals, with extraordinary sensitivity: in the parts-per-trillion range. Whole-genome sequencing capabilities will allow FDA scientists to assess if pathogens found in food are linked to human illness— and for economic purposes, to confirm that the fish that is described on the label is the fish that is actually in the package. FDA personnel will apply state-of-the-art technology for the analysis and detection of undeclared additives and unapproved colors in human and animal food.  The enhanced technologies here at the San Francisco Lab are crucial for protecting the safety of the food that Americans eat. Most of all, this facility’s modernization will help us ensure that our important resource—FDA personnel—can conduct their work safely and efficiently in support of FDA’s public health mission.

The modernization of the San Francisco Lab complements our work on FDA’s technical infrastructure. This is one of the tasks that I have been focused on as FDA’s Principal Deputy Commissioner and Acting CIO. 

We’re developing a comprehensive strategy for technology modernization at FDA and we’ll provide more details about this plan in the coming weeks.  First, and foremost, we are planning and executing a series of activities to modernize FDA’s technology infrastructure to make sure that we all have the IT solutions needed to conduct our daily business across FDA and here in FDA.

As I like to say, we need to “Nail the Fundamentals”. Indeed, we have seen IT help desk wait times reduce from nearly 7 minutes in 2017 to an average of 48 seconds in 2019 – and the most recent report that I saw shows that we are down to 15 seconds. Similarly, we have had fewer Severity 1 outages of our technical infrastructure reducing from 263 incidents in 2015 to 41 in 2018, and just 9 in 2019. Getting the fundamental technical infrastructure right matters a lot for the laboratory here in Alameda because it allows you to do your work and sets up the information highway on top of which the meaningful data that you generate can flow.

As a next step, we are moving to an even more “modern” future where we can support emerging uses of artificial intelligence, advanced analytics, real-time dashboards, blockchain, and other technologies. These technologies will help to accelerate and scale our work here in Alameda and across FDA.  And again, the data generated in laboratories will serve as critical substrate – electricity – to inform the algorithms embedded in dashboards, artificial intelligence capabilities and other solutions. Our efforts to build up FDA’s tech capabilities will be like a flywheel — building and using novel technologies leads to increased scaling of work across labs and the agency, which leads to more data that can feedback and inform the process. 

The modernization plan will also showcase nascent projects at FDA that provide a glimpse of the future applications of data and advanced analytics.  Think, for example, of new algorithms that let us use the types of data produced by this lab—such as whole-genome sequence data—in new and powerful ways. And technology modernization must be informed by—and occur in collaboration with—FDA’s diverse group of stakeholders, including those in the tech industry that are at the leading edge of technology’s application to medical product development and other areas related to FDA’s mission.

You won’t be surprised to hear that some of the most significant new technologies are being developed and deployed by the Office of Regulatory Affairs to equip our personnel in the field—like the dedicated staff here in Alameda—with state-of-the-art computational tools to enhance and extend their capabilities. As part of FDA’s new era of smarter food safety, the FDA is exploring the potential for artificial intelligence (AI) to improve screening of imported food before it is allowed into the United States for sale to U.S. consumers. 

FDA’s uses an import screening tool called PREDICT, or Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.  PREDICT helps FDA employees speed their review of import entries while targeting products based on risk. The tool is designed to automatically search and analyze large amounts of current and historical data. PREDICT helps FDA personnel identify patterns, flag issues, and determine the potential risk of new shipments in real-time. The increased number of automated decisions gives human reviewers more time to focus on higher-risk entries. PREDICT is a valuable tool for ensuring the safety of important food, but we are continuing to evaluate ways to make it smarter and even more efficient.

In a proof-of-concept project, PREDICT will serve as a testing comparator as FDA develops a prototype machine-learning model to identify imported seafood shipments that are more likely to be violative.     We expect that the machine learning model will improve the sensitivity, specificity, and predictive value of the selection model for import entry review.

Americans expect FDA to make decisions based on rigorous science-based on data.  FDA will continue to conduct the public health mission that has been entrusted to the Agency for many decades, but carefully designed technologies like PREDICT will let us operate more efficiently and effectively. And Alameda’s lab is a critical part of this story.

Thank you again to the many individuals who made today’s opening a success and, to all the FDA personnel at the San Francisco District Office and Lab: thank you for the important work you do to serve the American people. I am so proud to be a part of this agency and a member of your team.