FDA IT Systems Stink

FDA IT Systems Stink

April 18th, 2012 // 12:51 pm @


We all know that information technology can be a complex and sometimes confusing universe. But without IT, much could not get done. Take the FDA. The agency relies on IT to review products, collate adverse events reports and maintain compliance, among many other things. So having an up-to-date system is important. Unfortunately, the agency is woefully behind in upgrading its IT infrastructure, according to a new report from the US Government Accountability Office.

Despite spending about $400 million for IT investments in fiscal year 2011, the agency “lacks a comprehensive IT inventory that identifies and provides key information about the systems it uses and is developing,” the GAO writes. Other problems: the FDA does not have an actionable IT strategic plan, its enterprise achitecture remains incomplete and the agency has not planned adequately for IT personnel needs.

A key issue: “much work remains” to be done on its “largest and costliest system modernization effort,” which is called the Mission Accomplishments and Regulatory Compliance Services program. Estimated to cost about $280 million, MARCS is supposed to enhance existing applications and develop new systems that provide information for inspections, compliance activities and laboratory operations, the GAO points out.

“However, much of the planned functionality has not been delivered and its completion is uncertain. Moreover, the program lacks an integrated master schedule identifying all the work activities that need to be performed and their interdependencies,” the GAO laments, noting that the FDA Chief Information Officer says the agency is now reevaluating the entire scope of the program.

This means, of course, that it is uncertain when or if FDA will meet its goals of replacing key legacy systems and upgrading systems to support its functions. Some of the problems can be traced to an IT management structure that has been in “flux.” “Since 2008, the agency has had five CIOs, hampering its ability to plan and effectively implement a long-range IT strategy,” the GAO writes. “While the agency recently hired a CIO, without stable leadership and capabilities, the success of FDA’s modernization efforts is in jeopardy.”

In its defense, the US Department of Health & Human Services wrote the GAO that the FDA has only recently completed the first phase of a complex and “ambitious undertaking” that has, so far, yielded a modernized production data center and infrastructure that provides cloud computing. And the agency is creating a new project management office to oversee its efforts. However, as the GAO notes, HHS did not actually agree or disagree with most of the findings

Consequently, such warnings from the GAO will provide still more ammunition for agency critics, who are increasingly arguing the FDA needs to overhaul its philosophical approach to product approvals. The numerous failures – including an inability to maintain a schedule for revamping its most important IT project and repeated turnover in the CIO job – may make it that much harder for FDA commmish Margaret Hamburg to fend off attacks that the agency is an out-of-date dinosaur

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