The agency launched its openFDA initiative with the goal of easing the way for researchers and technology specialists to search, query or download large public health datasets collected by the FDA. Web and application developers, data visualization artists, researchers and the public can access public-health data in a structured, computer readable format.
“The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way,” said Walter S. Harris, the FDA’s chief operating officer and acting chief information officer. “OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”
Before openFDA, Freedom of Information Act requests and difficult to use reports were the only methods available to access datasets such as drug adverse events and medication errors. The FDA decided to phase in openFDA with a pilot program involving millions of reports of adverse events submitted to the agency from 2004 to 2013. Adverse event data made available in openFDA do not contain any information that could be used to identify individuals or other private information, FDA said.
The agency plans to expand the pilot to include the FDA's databases on product recalls and product labeling.
“Through this new and novel approach to data organization, these reports will be available in their entirety so that software developers can build tools to help signal potential safety information, derive meaningful insights, and get information to consumers and health care professionals in a timely manner,” said Dr. Taha Kass-Hout, the FDA’s chief health informatics officer. “OpenFDA offers a scalable platform that can be easily searched and queried across many distinct datasets, and can be easily redeployed or altered to fit a variety of purposes, and provides an innovative public data search and analytics solution.”