The U.S. Food and Drug Administration has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.
In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis.
OpenFDA utilizes a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data, ranking results much like a search using Google would do. This method then allows them to build their own applications on top of openFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users. This enables a wide variety of applications to be built on one common platform.
"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."
The initiative is the result of extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests.
The adverse events data made available under this initiative do not contain any data that could potentially be used to identify individuals or other private information. The pilot will later be expanded 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 Taha Kass-Hout, M.D., 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."
In addition to providing datasets, openFDA will encourage the innovative use of the agency's publicly available data by highlighting potential data applications and providing, a place for community interaction with each other and with FDA domain experts.
The FDA will continually work to identify additional public datasets to make available through openFDA. More information can be found at open.FDA.gov or you can email the FDA for more information at
The openFDA Initiative was formally launched with the creation of the Chief Health Informatics Officer (CHIO) and the Office of Informatics and Technology Innovation (OITI) at the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.