FDA’s IT earns mixed reviews in GAO report

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The Food and Drug Administration’s plan for buying and using IT isn’t linked closely enough to the agency’s overall mission objectives, according to a Government Accountability Office report — which also found the agency has made several tech improvements.

The watchdog found the agency’s IT strategic plan doesn’t directly address the priorities outlined in the “FDA Strategic Priorities: 2014-2018” document: regulatory science, globalization, safety and quality, smart regulation, and stewardship. And the IT plan lacks “goals and performance measures for determining whether its implementation is successful in supporting the agency’s mission.”

In all, the tech plan, the report said, was intended to reflect the mission of the Office of Information Management and Technology, not the whole agency.

“Until FDA incorporates into its IT strategic plan necessary elements that align the goals and objectives with its overall mission, the agency will continue to lack critical information needed to ensure that information resources support business strategies and investment decisions,” the report said.

At the same time, GAO commended the agency for addressing six of the nine recommendations made in two previous reports, including one to develop an IT systems inventory to manage investments.

The report noted the agency is heavily reliant on its technology systems, which not only support administrative functions, like payroll, but help examiners as they review new drugs or screen imported foods. FDA received about $578 million in IT funding for fiscal year 2015, according to the watchdog.

In a response attached to the report, its parent agency, the Department of Health and Human Services, said FDA had established a process for updating its strategic IT plan this October.

“As part of this workflow process, FDA monitors the milestones that are targeted for completion during the month,” it said. “Monthly reminders are submitted to the project owners and a review is conducted with IT Leadership at the end of each month.”

In an email, FDA spokeswoman Andrea Fischer said the agency takes care to ensure its strategic IT initiatives align with its strategic objectives.

“This plan is a living document that can be modified to account for changes in technologies and mission-related objectives, providing flexibility to course correct as technology changes and mission specific requirements evolve,” she said.

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Department of Health and Human Services (HHS), Departments, Food and Drug Administration
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