On June 2, 2014, FDA announced the launch of OpenFDA at https://open.fda.gov, a new initiative from the FDA Office of Informatics and Technology Innovation (OITI). OpenFDA is designed to make it easier for developers, researchers, and the public to access and use the many large health data sets collected by the agency. The publicity available data sets once integrated and analyzed can provide knowledge and insights that can’t be gained from any other single source.
In the past, FDA’s vast datasets were difficult for industry to access and to use. Pharmaceutical companies would send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that was one of the ways to obtain this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click to browse through a database.
OpenFDA will make FDA’s publicly available data accessible in a structured, computer-readable format. It will provide a search-based Application Programming Interface (API) which is a set of requirements that govern how one software application can talk to another and find both structured and unstructured content online.
Software developers can now build their own applications such as a mobile phone app or an interactive website that can quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets in real-time on an as-needed basis. In addition, applications can be built on one common platform that is free and open to use.
The first dataset deals with drug adverse event with reports submitted from 2004 through 2013 is now available. Using this data, a mobile developer could create a search app for a smart phone so that a consumer could then determine whether anyone else has experienced the same adverse event that they did after taking a certain drug.
OpenFDA uses technologies that are deployed on FDA’s new Cloud Computing infrastructure enabled by OITI that will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently.