How openFDA's 'crazy collision' of Silicon Valley and federal culture is reshaping the regulator

Print 02 September 2015
Nick Paul Taylor / Fierce Biotech IT

Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative.

FDA Chief Health Informatics Officer Dr. Taha Kass-Hout--Courtesy of the FDA

Bio-IT World dug into the genesis of precisionFDA and its implications in a feature this week. The initiative sees the FDA hook up with West Coast cloud genomics pioneer DNAnexus to work on a system to house well-curated sets of DNA data and reference computational pipelines. That the FDA is working with DNAnexus on the system is, in part, a consequence of the regulator's data-sharing program. The collaborators first met at a gathering to mark the start of openFDA, an event that made DNAnexus Chief Cloud Officer Omar Serang reassess his image of the FDA.

"Our jaws dropped to see a federal agency using GitHub, holding code hackathons. It was a crazy collision of Silicon Valley culture and federal government culture," Serang said. That same ethos, which began percolating through the government when open-source advocate Beth Noveck took up a position at the White House in 2009, is central to precisionFDA. People in positions to influence decisionmaking at the FDA have become increasingly convinced of the value of an open ethos, leading to a tweaking of the regulator approaches projects such as precisionFDA.

"The initial intention for openFDA was to provide easier access to already publicly available data, but we've seen how further innovation happened from the marketplace and from users, especially the researcher community. So hopefully some surprise will come from the community that we haven't thought about. This is the beauty of making this open," FDA Chief Health Informatics Officer Taha Kass-Hout said. The idea is that precisionFDA will give the genomics sector a chance to influence how the FDA looks at the field.

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