Regulatory Focus™ > News Articles > In Unprecedented Project, FDA Prepares to Free its Own Data

In Unprecedented Project, FDA Prepares to Free its Own Data

Posted 03 February 2014 | By Alexander Gaffney, RAC

Data transparency has been all the rage in the life science industry as of late, with industry groups and companies pledging to release their clinical trials data to researchers and the public. But at the institutional level, transparency doesn't always mean access. Instead, sometimes the best transparency refers to ease of access.

And now, thanks to a 2012 White House digital strategy initiative, the US Food and Drug Administration (FDA) is gearing up to grant the public unprecedented ease of access to some of its most sought-after information.


In May 2012, the White House instructed the FDA and other federal agencies to immediately begin implementing a new "digital strategy" aimed at making governmental information more readily and easily accessible to the public.

 "Today's amazing mix of cloud computing, ever-smarter mobile devices, and collaboration tools is changing the consumer landscape and bleeding into government as both an opportunity and a challenge," explained a 2012 report accompanying the White House memo.

"To build for the future, the Federal Government needs a Digital Strategy that embraces the opportunity to innovate more with less, and enables entrepreneurs to better leverage government data to improve the quality of services to the American people."

The core of the report was focused on what are known as APIs. No, not active pharmaceutical ingredients-application programming interfaces, standardized data formats which specify how various pieces of software communicate with one another.

Open APIs would hypothetically allow people to access the raw data FDA puts out through its various databases-approvals, adverse event reports, recall notices, etc-and repurpose them, potentially making them easier to use or more enjoyable to read.


Since the May 2012 executive directive, FDA has been relatively quiet about its open data efforts. The Department of Health and Human Services (DHHS), FDA's parent organization, has been primarily focused on open data projects involving the rollout of the Affordable Care Act, and its Digital Strategy webpage seemingly contains just one FDA-related project: the November 2013 launch of FDA's new mobile-friendly website.

But FDA's limited actions with respect to the federal Digital Strategy initiative now seem poised to change in a major way.

In January 2014, FDA quietly announced a new webpage and initiative called openFDA (

Dubbed as an "exciting new initiative" run by FDA's Office of Informatics and Technology Innovation (OITI), "openFDA will offer easy access to FDA public data and highlight projects using these data in both the public and private sector to further regulatory or scientific missions, educate the public, and save lives."

FDA explained that openFDA will soon provide "API and raw download access to a number of high-value structured datasets," including adverse events, recalls, and documentation like structured product labeling (SPL) data, confirming Regulatory Focus' May 2012 speculation.

The project, though, is still very much in its infancy. FDA said beta access to the openFDA API will only open in summer 2014 at earliest, with full public release expected by the end of 2014.


openFDA Webpage

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