News Feature | June 6, 2014

OpenFDA Initiative To Provide Easier Access To Agency Data

By Nick Otto

This week, the FDA kicked off its newest transparency initiative, openFDA, with a new database containing millions of reports of adverse events that were previously available only through difficult-to-use reports or Freedom of Information Act requests.

Technology specialists, such as mobile application creators, web developers, data visualization artists, and researchers, will be able to quickly search, query, or pull massive amounts of information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use.

According to the Regulatory Affairs Professionals Society (RAPS), the agency earlier this year  “quietly announced the addition of a new webpage,, which it said would soon ‘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.’”

The site was said to provide a number of high-value structured datasets, including adverse events, recalls, and documentation like structured product labeling data, RAPS added.

The Hill notes that currently, the program has released more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013.

However, the FDA said that future data will also focus on medical devices and food products.

Shortly after unveiling the website, mHealth News noted the appearance of what some are saying is the first app to tap into the FDA’s data search engine.

Social Health Insight, the developer behind the early version app, says the idea of the app is a user can input search criteria, including adverse event dates, patient age, country, and manufacturer – to name a few – then hit a “show me the data” button.

Along with the openFDA initiative launch, the FDA says it also created Chief Health Informatics Officer (CHIO) and the Office of Informatics and Technology Innovation (OITI) positions at the agency.

To ease industry concerns, an FDA blog post said that as more public data becomes easily accessible, the agency will not release any data that could be used to identify individuals or reveal other private information such as industry trade secrets.