Every year the FDA receives hundreds of Freedom of Information Act requests from biopharma companies for adverse-event data, while others take equally laborious steps to access the information. Now this could be coming to an end, with the FDA opening up its adverse-event data through an application programming interface (API).
|FDA chief health informatics officer Dr. Taha Kass-Hout--Courtesy of the FDA|
The adverse-event API is the first phase of the openFDA initiative the agency unveiled earlier this year. Software developers can use the API as the basis for a mobile app or interactive website, potentially making the data more accessible to patients and researchers. Having added data on adverse events from 2004 to 2013, FDA is now working on the next two data sets: product labels and recalls. Further releases are scheduled for later in the summer.
FDA informatics chief Dr. Taha Kass-Hout announced the news in a blog post, with Presidential Innovation Fellow Sean Herron publishing an accompanying piece giving technical details of the API. The success of the initiative is at least partly dependent on getting software developers on board. And early signs are positive, with news of the API hitting the front page of software developer forum Hacker News.
Contributors to the forum welcomed the openFDA initiative, particularly its open-source ethos. Over time the community could use the API for a variety of projects, but the first example of its potential comes from the FDA. The agency released an interactive website that allows users to dig into and visualize the adverse-event data, for example by showing which classes of drugs cause the most serious reactions. Social Health Insights has also created an interactive website using the API.