IT investments not bearing fruit at FDA, report finds

Agency efforts to modernize -- including a decade-old $280 million initiative -- have fallen flat, GAO says.

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The Food and Drug Administration is failing to adequately modernize its information technology operations and one costly decade-old initiative in particular has achieved little, a new report has found.

FDA has spent more than $280 million on an IT modernization program since 2002, which due to numerous setbacks and restarts is still far from accomplishing its initial goals, according to a Government Accountability Office report issued March 15 and published Monday.

FDA's Mission Accomplishments and Regulatory Compliance Services program was launched in 2002 to enhance the agency's existing IT applications and improve employee access to information, because certain legacy data storage systems at the time were not integrated with their more modern counterparts. Three years later, in 2005, the agency put MARCS developments on hold partially to redirect resources to its data center modernization effort, according to GAO.

FDA revised its MARCS baseline four times -- in 2006, 2007, 2009 and 2011 -- to accommodate additional costs and more legacy systems that needed replacement, according to GAO. When MARCS began, the program sought to replace only two legacy systems with Web-based ones. Since 2002, six additional legacy systems have been added to MARCS modernization efforts, and GAO says none of the eight systems had been replaced as of February.

Additionally, of around 30 service components that MARCS sought to implement, only eight had reached the implementation or maintenance phases as of February, and FDA had yet to begin work on 12, according to the watchdog agency.

"Significant work remains for FDA to fully implement standardized data sharing," GAO said in the report.

GAO made several recommendations to FDA leadership, including developing a comprehensive inventory of its IT systems. Concerning MARCS, GAO recommended FDA develop an integrated master schedule that identifies which legacy systems are to be replaced and when, as well as all current and future tasks to be performed, and use the schedule to monitor progress.

FDA's parent agency, the Health and Human Services Department, neither agreed nor disagreed with GAO's recommendations. In comments submitted to GAO, the department said FDA has taken actions to address many of the issues and there are several stages to its IT modernization initiative.

This is not the first time GAO has placed FDA's computer systems modernization efforts under the microscope. A 2009 report said FDA lacked a strategic plan to synchronize its many disparate innovation initiatives.

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