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Regulatory Focus – FDA says IT modernization came at right time for COVID

Regulatory Focus – FDA says IT modernization came at right time for COVID

While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in time, according to FDA Commissioner Robert Califf.

On 31 March, FDA published its Modernization in Action 2022 report that outlines how the agency’s efforts to modernize its IT systems have helped address the global COVID-19 pandemic. The agency notes its efforts have allowed staff to work from home safely and work more efficiently with medical manufacturers to get much needed products to market.

In 2019, then FDA commissioner Scott Gottlieb brought Amy Abernethy on board as principal deputy commissioner, specifically to lead the agency’s efforts to modernize its IT infrastructure. While also serving as the agency’s chief information officer (CIO), Abernethy elevated the issue of IT modernization to the commissioner level and set the groundwork for FDA to adopt its Technology Modernization Action Plan (TMAP) in 2019 and the Data Modernization Action Plan (DMAP) in 2021.

Though Abernethy left FDA to head Verily Life Sciences’ Clinical Studies Platform in 2021, the agency has continued her work under Vid Desai, who stepped up to the role of CIO after Abernethy’s departure.

In a joint blog post, Desai and Califf touted the report’s findings as proof its work to modernize its IT systems has been a major success in helping regulators manage the pandemic.

“The COVID-19 pandemic accelerated these changes and underscored the importance of aligning technology and data strategies to drive positive outcomes in our critical work addressing public health challenges,” they wrote. “From how we integrate new technology into medical product application reviews and food safety efforts, to facilitating the use of data insights to help treat disease, technology and data are ubiquitous in the work of the [FDA].”

The top FDA officials note that the pandemic brought about an abrupt yet seamless shift for agency staff to work from home, which meant handling 25,000 users on its IT systems and pushing back against a cybersecurity onslaught from malicious hackers including nation state actors.

“From hosting more than 429,000 virtual meetings annually, to managing more than 2,400 applications and databases, to managing a 457% increase in cyber-attacks compared to pre-pandemic levels, the FDA met these challenges as a result of modernization efforts combined with the hard work of the FDA workforce,” Califf and Desai state.

They also note that FDA’s Office of Digital Transformation (ODT) established a team to focus on getting new talent who could help the agency handle the added IT workload.

“These activities have led to a 9.6% hiring increase over the prior year and a 17% improvement in Federal Employee Viewpoint scores,” they note.

The modernization report goes into more detail about how FDA was able to manage much of its work culture shift during the pandemic which includes adopting apps from Microsoft Office 365, moving much of their data from physical servers to cloud-based servers for better access, and allowing seamless user experience regardless of the hardware platform.

A major IT effort during the pandemic was the creation of the Evidence Accelerator in partnership with the Reagan-Udall Foundation and the Friends of Cancer Research. The accelerator includes collaboration with nearly 120 external organizations to share real world data and expertise, which can then be used to help develop drugs, vaccines, medical devices and diagnostics to help tackle the pandemic.

While the modernization efforts are being touted as a success, they haven’t come without their fair share of hurdles.

Trying to get funding for the efforts hasn’t always been easy and past commissioners have lobbied Congress for funds needed to modernize FDA’s IT systems.

During the Medical Device User Fee Amendments (MDUFA V) negotiations, the agency and medtech industry representatives hit a snag when industry took issue with FDA using user fee carryover funds to upgrade its IT systems. Industry argued that use of the funds for IT systems was not part of its MDUFA IV agreement. Eventually, the two sides worked things out, and the new proposed deal includes additional dollars for FDA to make upgrades to its IT systems.