FDA criticized for incomplete IT modernization plans

The Food and Drug Administration lacks a comprehensive strategy for 16 agencywide initiatives to centralize and modernize computer systems, according to a new report from the Government Accountability Office.

FDA has developed two high-level planning documents, but they are short on details, the report (GAO-09-523) stated. The agency's Strategic Action Plan, approved in fall 2007, leaves out some projects and does not indicate how officials will measure performance or set milestones to track progress, auditors said. The 2008 Information Technology Plan for the Prescription Drug User Fee Act also is limited in the initiatives it covers and fails to consider interdependencies among projects, according to the report.

Agency officials said they must resolve near-term planning and investment decisions before completing long-term plans, but GAO countered that "without a strategic plan to sequence and synchronize these initiatives based on a comprehensive picture of its strategic IT goals, [FDA] increases the risk that its modernization efforts will not be effective."

The projects at stake include consolidating FDA's technology infrastructure to provide 12,000 employees services such as help desk support and access to customer relationship, planning and project management programs; developing the Sentinel system for pulling electronic information from health care organizations to assess the risks of medications; and upgrading eight legacy computer systems used to inspect product imports.

In addition to the 16 agencywide initiatives, FDA is enhancing its IT management capabilities by gathering information on needed skills, and soliciting contract support to improve application security, according to the report.

A comprehensive strategic plan would help the agency allocate resources among projects and make smart investment decisions, GAO said. Furthermore, such plans are required under two Office of Management and Budget directives: circulars A-130 and A-11.

The watchdog recommended that FDA set a timeline for developing a comprehensive IT modernization plan that includes results-oriented goals, performance measures and an analysis of interdependencies among projects.

In a written response, FDA officials agreed with GAO's recommendations and noted that work on a strategic plan began in August 2008 and is ongoing. "Planning efforts have included a high-level analysis of our most immediate needs and priorities, as well as taking a longer range view of the functionalities and capabilities FDA will need in the coming years," they stated.