Government Accountability Office Says FDA Needs Strategic Plan For IT
Full article reprinted from "The Gray Sheet" - June 8, 2009
FDA has at least 16 projects under way to improve its information technology systems and infrastructure, but no comprehensive IT strategic plan to coordinate and manage the efforts, according to the Government Accountability Office. Find out more...
Full article reprinted from "The Gray Sheet" - June 8, 2009
FDA has at least 16 projects under way to improve its information technology systems and infrastructure, but no comprehensive IT strategic plan to coordinate and manage the efforts, according to the Government Accountability Office.
Without such a plan, "the agency increases the risk that its modernization efforts will not be effective," GAO warns in a report released June 2.
Specifically, FDA needs a comprehensive plan describing what it seeks to accomplish and containing well-defined goals, strategies, milestones and performance measures that will indicate whether it is succeeding, GAO says.
FDA also needs to analyze how the many ongoing projects and activities are interrelated.
The study, "Information Technology - FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts," was done at the request of Senate HELP Committee Chairman Edward Kennedy, Senate Finance Committee ranking member Chuck Grassley, House Energy and Commerce Committee Chairman Henry Waxman, and House Oversight and Investigations Subcommittee Chairman Bart Stupak.
Currently, FDA relies on numerous "mission-critical" IT systems to review and evaluate new product applications, oversee manufacturing sites and production supply chains, and monitor the safety of products on the market.
But several recent studies have found limitations in a number of areas, GAO notes. Systems are aging, advances in science and technology are outpacing the capabilities of FDA's IT infrastructure and systems, and the IT staff is not sufficiently skilled in certain areas.
- Ingrid Mezo
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