IT Fix Underway, Says FDA Commissioner; More Funds Needed, Say Critics
This article was originally published in The Gray Sheet
Executive Summary
In a contentious congressional hearing Jan. 29, FDA Commissioner Andrew von Eschenbach conceded that FDA's flawed information technology infrastructure impedes the agency's ability to monitor device and drug safety, but refused to say how much money would be needed to improve the IT systems
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Regulatory News In Brief
FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)
Regulatory News In Brief
FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)
Bush Budget Request Would Cut 10 Staff Positions At FDA Device Center
President Bush's Feb. 4 budget request asks for about $7 million in additional funds for FDA's device program in fiscal year 2009 compared to current levels, but would cut 10 full-time staff equivalents at CDRH