Congress' watchdog has chased down a number of weak points in the FDA's plan to modernize its IT systems, which support key activities impacting the biopharma industry, including safety monitoring, drug and device reviews and inspections of manufacturing facilities.
The Government Accountability Office (GAO) report found that the FDA lacked a comprehensive list of its IT assets, on which the agency spent more than $400 million during fiscal 2011, and that the unstable IT leadership over the past several years has put modernization efforts "in jeopardy." The watchdog called into question whether the FDA would accomplish the goals of its $280 million IT modernization effort, after the agency's IT chief told the GAO that the scope of the pricey project is under review.
"As a result, it is uncertain when or if FDA will meet its goals of replacing key legacy systems and providing modernized functionality to support its mission," the GAO wrote in a summary of its findings.
"In addition," the GAO continued, "FDA has not yet fully implemented key IT management capabilities essential for successful modernization, as previously recommended by GAO. These include developing an actionable IT strategic plan, developing an enterprise architecture to guide its modernization effort, and assessing its IT human capital needs."
Part of the blame falls on the revolving door in the top IT post at the FDA. The agency has had 5 chief information officers since 2008, according to the GAO report, leaving the leadership of IT in flux. Eric Perakslis, a former head of IT R&D at Johnson & Johnson ($JNJ), was tapped for the CIO post at the FDA late last year, giving him little time to right the infotech ship at the agency.
Perakslis has a huge challenge in front of him to transform IT at the FDA with modern capabilities to support vital aspects of the biopharma industry and other industries that the agency regulates. FierceBiotech IT is scheduled to meet with the FDA's information chief very soon to discuss his vision for improving IT at the agency.
- see the GAO's summary
- and MedPage Today's report