Audit finds shortcomings in how FDA manages IT investments

The Food and Drug Administration is modernizing its information technology systems but may need more  IT management tools to perform those updates successfully, according to a new report from the Government Accountability Office.

The FDA spends about $400 million a year on IT investments, but while it is making progress it needs to do a better job of monitoring and managing those investments, the GAO said in the April 16 report.

For example, one shortcoming is the lack of a comprehensive inventory of system information, costs, functionality and development or operating status, as required by the Office of Management and Budget.

While the agency has some partial documentation, that is not enough, the GAO audit said.

“Until the agency has a complete and comprehensive inventory, it will lack critical information needed to effectively assess its IT portfolio,” the auditors concluded.

Furthermore, the FDA’s Mission Accomplishments and Regulatory Compliance Services program, which is estimated to cost $280 million, is having difficulties. The system is intended to provide data for inspections, compliance activities and laboratory operations.

But much of the planned functionality has not been delivered and “completion is uncertain,” the GAO report said. Furthermore, there is no integrated master schedule identifying all work to be performed and interdependencies. The agency said it is reevaluating the scope of the initiative.

FDA also is falling short on developing an actionable IT strategic plan, developing an enterprise architecture to guide its modernization effort, and assessing its IT human capital needs, as the GAO had previously noted.

The situation reflects, in part, recent turnover in IT management, the GAO noted.

“FDA’s IT management structure has been in flux. Since 2008, the agency has had five CIOs, hampering its ability to plan and effectively implement a long-range IT strategy. While the agency recently hired a CIO, without stable leadership and capabilities, the success of FDA’s modernization efforts is in jeopardy,” the report concluded.

The watchdog agency recommended that FDA develop a comprehensive inventory, integrated master schedule and assess other information needs.

Health and Human Services Department officials who reviewed the draft report neither agreed nor disagreed with its findings and recommendations, the report said. The HHS officials said FDA has taken actions to address the issues raised in the report.