When the FDA laid out its strategic priorities for 2011 to 2015, the agency listed the modernization of its IT infrastructure as a primary objective. Since then, the FDA has seen another chief information officer pass through its revolving doors and faced criticism from the Government Accountability Office (GAO), but is still plugging away with the IT modernization agenda in its next strategic plan.
The new draft plan covers 2014 to 2018, a period in which the FDA plans to continue building the data sharing and bioinformatics capabilities it thinks are essential to regulators today. Investment in IT is central to the agency's infrastructure plans for the coming years, with the FDA singling out spending on integrated information and shared data resources as a particular priority. The goal is to establish ways of sharing data and informatics both internally and externally.
Similar goals featured prominently in the 2011 to 2015 document, and their status at the start of that period was documented in the GAO report, which was less critical of the FDA's data-sharing work than some of its other initiatives. GAO said the data-sharing project had made "mixed progress," but the FDA has expanded its efforts since that assessment, for example by forming coalitions with its peers. The latest plan calls for a data-sharing network to speed the spread of information between regulators.
The success of this initiative and other initiatives that tap IT and data analytics will go a long way toward dictating whether the FDA can better manage problems created by globalization while helping pharma get drugs to patients faster.
- read the FDA strategy (PDF)