GAO: FDA spending plenty on IT modernizationand getting nowhere fast
 |
GAO presented its recommendations in a new report, “FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks,” which was released to the public April 16.
The report says FDA spent about $400 million for IT investments in 2011 but still lacks that all-important comprehensive inventory, which would provide key insight into the systems it uses and is developing. It also points out that the Office of Management and Budget (OMB) and GAO guidance call for federal agencies to maintain such an inventory to monitor and manage their IT investments. The inventory “should contain information used to measure the progress and value of the investments, such as benefits to the mission, schedule, risk assessments, and performance metrics,” reads the report.
“Without a complete inventory of IT information, an organization cannot develop an adequate investment control process, and consequently, will lack the foundation for demonstrating the impact of alternative investment strategies and funding levels for the agency’s inventory of information resources.”
Meanwhile, much work remains to be done on FDA’s largest and costliest system modernization effort—the $280 million Mission Accomplishments and Regulatory Compliance Services program, according to the report. This program is aimed at enhancing existing applications and developing new systems that provide information for inspections, compliance activities and laboratory operations. Much of the planned functionality “has not been delivered and its completion is uncertain,” said GAO in a report summary. “Moreover, the program lacks an integrated master schedule identifying all the work activities that need to be performed and their interdependencies.”
FDA’s CIO, Eric Perakslis, PhD, installed just last October, told GAO that the agency is re-evaluating the scope of the compliance-services initiative. “As a result, it is uncertain when or if FDA will meet its goals of replacing key legacy systems and providing modernized functionality to support its mission,” said GAO. “In addition, FDA has not yet fully implemented key IT management capabilities essential for successful modernization, as previously recommended by GAO. These include developing an actionable IT strategic plan, developing an enterprise architecture to guide its modernization effort and assessing its IT human capital needs.”
GAO said these shortcomings are due in part to the fact that FDA’s IT management structure 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,” said GAO. “While the agency recently hired a CIO, without stable leadership and capabilities, the success of FDA’s modernization efforts is in jeopardy.”
As for data sharing, FDA has initiatives in the works to adopt an enterprise-wide standard for formatting data and several projects aimed at enhancing its ability to share data. Effective data sharing is essential to its review and approval process, inspection of imports and manufacturing facilities, and tracking of contaminated products, GAO noted. “However, these projects have made mixed progress, and significant work remains for FDA to fully implement standardized data sharing. Further, FDA’s Center for Food Safety and Applied Nutrition has not comprehensively assessed information-sharing needs to ensure that its systems and databases are organized for effective information sharing,” added GAO. “This is needed to help ensure more efficient access to and sharing of key information supporting its mission.”
GAO said it did the study in response to a request from the department to which it reports, Health and Human Services (HHS). It was tasked with evaluating FDA’s current portfolio of IT systems, assessing the status and effectiveness of the agency’s efforts to modernize the mission-critical systems that support its regulatory programs, and examining the agency's progress in effectively integrating and sharing data among key systems.
GAO said that, in commenting on a draft of the report, HHS neither agreed nor disagreed with its recommendations but stated that FDA has “taken actions to address many of the issues” discussed in the report.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.