Regulatory Focus™ > News Articles > Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

Report: Future of FDA's $280 Million IT Improvement Program 'Uncertain'

Posted 17 April 2012 | By Alexander Gaffney, RAC 

A report issued by the Government Accountability Office (GAO) has found the US Food and Drug Administration's (FDA) information technology (IT) infrastructure improvement project-a $280 million program known as the Mission Accomplishments and Regulatory Compliance Services (MARCS) program-is suffering from a cavalcade of operational deficiencies and may not be completed.

The program "is intended to enhance existing applications and develop new systems that provide information for inspections, compliance activities, and laboratory operations," explains GAO in its report, FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks.

"However, much of the planned functionality has not been delivered and its completion is uncertain," wrote GAO.

FDA's infrastructure project lacks a number of key oversight and functional capabilities that may ultimately prevent it from being completed, stated GAO. These include a lack of "an integrated master schedule identifying all the work activities that need to be performed and their interdependencies," incomplete management capabilities previously recommended by GAO, a strategic plan for the project, the turnover of five Chief Information Officers throughout the project and un-assessed human capital needs.

"As a result, it is uncertain when or if FDA will meet its goals of replacing key legacy systems and providing modernized functionality to support its mission," concluded GAO.

GAO also noted FDA lacked some essential safeguards for its larger IT modernization efforts, including a comprehensive IT inventory of systems, costs, functionality, purpose and status. FDA's 2011 budget for IT modernization was $400 million dollars, or roughly 20% of its congressionally appropriated dollars, which was spent on 44 projects, 21 of which were defined as mission critical.

GAO wrote it is "recommending that FDA develop a comprehensive inventory of its IT systems, develop an integrated master schedule for a major modernization effort, and assess information needs to identify opportunities for greater sharing."

The US Department of Health and Human Services, responding on behalf of FDA, said it believes "FDA has [already] taken actions to address many of the issues in the report."

Read more:

GAO - FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks

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