No Increased Budget for IT Modernization: Abernethy

FDA’s large-scale and ambitious plan to modernize its information technology (IT) use will not be seeing any increased funding under the fiscal year 2020 budget, FDA principal deputy  ommissioner Amy Abernethy acknowledged 2/19 during an Alliance for a Stronger FDA Update. She said that the current budget for technology is being realigned to build the “overall technical enterprise” to be ready to move ahead with a more “cloud-forward strategy, and to make sure we have the right cybersecurity in place.” She said that the current work will inform the agency as to what budget increases will be needed in the future.

Now with a year of FDA experience under her belt, Abernethy has been spearheading IT modernization under the agency’s 9/2019-released Technology Modernization Action Plan that describes short-term actions it is taking to modernize technology use — computer hardware, software, data, and analytics. The plan has three elements: (1) modernizing FDA’s technical infrastructure; (2) enhancing its capabilities to develop technology products to support its regulatory mission; and (3) communicating and collaborating with stakeholders to drive technological progress.

In January, Abernethy began pushing for advancing the agency’s enterprise data plan. She told the Alliance that the enterprise plan should address issues such as if there is a new technology infrastructure then what does that mean in terms of how FDA uses data differently in the future, and how to grapple with issues such as privacy, confidentiality and data sharing and combining data to be more efficient.

To illustrate how IT modernization will improve efficiencies, Abernethy explained to the Alliance that the agency will pilot “use case” to advance its product development abilities and expertise. One ongoing use case involves seven- and 15-day safety reporting for INDs. Currently, the reports are submitted in .pdf files on Medwatch forms, but not in exchangeable data that is readily analyzable, she said. Since the generated Medwatch forms include data from company databases, FDA proposed to “connect” company databases directly to FDA and create an application programming interface between companies and FDA to put data directly into agency repositories.

“Once we realized industry wanted this to move forward, we built the appropriate secure infrastructure to allow such data to come directly to FDA through that conduit,” she said. “And now, in the next two years we will be moving to a world where that is the way we will receive all seven- to 15-day safety data. We can now showcase the value of building these conduits that allow us to bring in structured data directly into FDA, where appropriate.”

In the future, Abernethy sees real-world evidence requiring many technology changes at the agency. She said FDA will need to improve the way it receives structured data, and it needs better ways to quickly sift through and analyze information.

Abernethy said the agency is ready to receive feedback on its IT plans, and stakeholders can submit comments to a new public docket. The docket was established for a 3/27  public meeting that will discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.