FDA Launches openFDA Initiative

The Food and Drug Administration (FDA) announced in a press release that it has launched openFDA, a website portal making it easier for researchers, web developers, and the public to delve into the FDA’s data vault. Users can access information from FDA datasets using search and query functions. The initiative is part of a larger effort by the FDA to manage and mine its data. In this effort, it has identified data that is commonly requested and difficult to access, for instance reports that were previously only available through the Freedom of Information Act.

Additionally, the site encourages software developers to build tools that analyze data and derive meaning for future research. Walter S. Harris, the FDA’s chief operating officer and acting chief information officer, said, “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.”

OpenFDA Website

The OpenFDA website is a new resource for pharmaceutical companies, contract research organizations (CROs), academic institutions, community groups, physicians, and consumers. The FDA hopes that the portal will inspire innovation and new discoveries, and protect and educate the public. The FDA has large databases collected over time that the agency hopes will, with fresh perspective, spur development. 

The FDA stated that the portal will provide information in an easily accessible, structured, and readable form. Invited to participate are software developers (web and mobile), data visualization companies, independent experts, academics, private industry, and the public. Users have access to the Application Program Interface (API), which searches and sorts data hierarchically, enabling developers to build an application on top of the API. 

The pilot program available now is adverse drug event reports from 2004 to 2013. This project was selected after extensive consideration with internal and outsourced experts. They chose this dataset first because that information is traditionally hard to find and is often in demand. The next release from the data vault is information on product recalls and product labeling.

OpenFDA Initiative

The openFDA website is part of the openFDA Initiative and is aligned with a recent Presidential Executive Order on Open Data in May of 2013 and the Department of Health and Human Services Health Data Initiative. In Section 2.b Open Data Policy in the Executive Order, the order states, “Agencies shall implement the requirements of the Open Data Policy and shall adhere to the deadlines for specific actions specified therein.” The FDA responded to these orders and policy changes by establishing the openFDA Initiative, appointed its first Chief Health Informatics Officer (CHIO), and established the Office of Informatics and Technology Innovation (OITI).