The Food and Drug Administration would use millions of dollars in extra fiscal 2009 funds to upgrade its information technology to tie together multiple databases so it can better track food-borne diseases and possible adverse effects from medical devices, the agency's chief information officer said on Wednesday.
Comment on this article in The Forum.FDA has asked for a $65 million increase in its fiscal 2009 IT modernization budget to make multiple food and medical device databases interoperable and eliminate manual paper-based processes, said Tom Stitely, the agency's CIO. FDA had requested a $252 million IT budget for fiscal 2009, up slightly from $248 million in fiscal 2008. The additional $65 million will push the 2009 IT budget to $317 million.
The increase also will beef up scientific computing capacity that FDA researchers use, including adding supercomputers, he said. FDA is discussing with the National Institutes of Health to use its high-performance computers while studying whether to bring the technology in house, Stitely said.
The boost to its IT budget is part of a $275 million hike in FDA's budget that Michael Leavitt, secretary of the Department of Health and Human Services requested on Monday. FDA would use the extra money, he said, to improve the safety of the nation's food supply, drugs and medical devices such as pacemakers. The announcement followed an outbreak last week of food poisoning from tomatoes, which were tainted with salmonella bacteria and led to grocery and restaurant chains pulling tomatoes from their shelves and menus.
The increase in the FDA budget closely matches the $265 million the Senate added last month to the agency's fiscal 2008 budget. The increase was part of the 2008 Defense Department supplemental appropriations bill, which President Bush has threatened to veto because it includes funding for domestic programs such as expansion of educational benefits for veterans.
Stitely said the FDA plans to use the increase in the fiscal 2009 IT budget to build databases that pull electronic information from food vendors and medical device manufacturers to make it easier to trace specific food products and devices back to a particular food company or medical device manufacturer.
Tapping into that information is particularly helpful in tracking food contamination because the agency needs advanced systems to know the origin of a food product, said Robert Miller, FDA's deputy budget officer. The Centers for Disease Control and Prevention still has not identified the origin of the tomatoes infected with salmonella bacteria since the first cases appeared last week.
FDA must develop unique identifiers for each food vendor and device manufacturer to conduct the tracing process through a project called "harmonized inventory," Stitely said. The agency currently uses multiple identifiers, a practice that makes the inventory of vendor facilities and their points of contact unreliable because the data is not consistently updated across multiple systems, said Christopher Kelly, an FDA spokesman.
Kelly added that identification systems for products are fragmented across FDA, which means the agency cannot link products by identity, type, components or food ingredients, or manufacturing facility. Linking the information is critical if FDA wants to better screen imported products, review regulated products and identify products that must be recalled, Kelly said.
FDA is considering using radio frequency identification tags, among other technologies, to improve tracking of food products and medical devices. In 2004, the agency launched a project to encourage drug manufacturers to use RFID tags to track drugs.
Leavitt's increased budget also would include more frequent inspections of vendors and manufacturers overseas, and Stitely said inspectors -- including almost all of the agency's 10,000-person workforce -- would be equipped with ThinkPad laptops under a three-year contract FDA has with manufacturer Lenovo. Outfitting most FDA employees with laptops will allow them to continue to work from remote locations in case of a disaster or a pandemic flu outbreak, he said.