GAO: The FDA needs strategic IT plan

The Food and Drug Administration doesn't have a comprehensive strategic plan to guide its numerous information technology modernization initiatives, according to a new report from the Government Accountability Office.

The FDA has developed partial plans for at least 16 enterprisewide IT projects, including the MedWatch Plus Web portal for health providers and the public to report illnesses and other adverse events from medical products.

However, most of the existing strategic plans lack details, such as milestones and performance measures, according to the GAO report posted June 2 on the Web. The report recommends that the FDA take a comprehensive approach to its IT planning.

“A comprehensive IT strategic plan, including results-oriented goals and performance measures, is vital for guiding and coordinating the agency’s numerous ongoing modernization projects and activities. Until it develops such a plan, the risk is increased that the agency’s IT modernization may not adequately meet the agency’s urgent mission needs,” GAO wrote.

In recent years, the FDA has made mixed progress in improving IT management and human capital management, the report said.

But the agency has not analyzed what IT skills it needs in its workforce, and where gaps exist. In addition, significant work needs to be done on enterprise architecture development, GAO said.

In their response to the report, FDA officials said they have been working on drafting a strategic IT plan since August 2008 and expect to complete it by Sept. 30.