Photo: FDA / Michael J. Ermarth

The U.S. Food and Drug Administration’s openFDA initiative aims to “make it easier for web developers, researchers, and the public to access large, important public health datasets.”

Initial areas of focus include adverse event and recall enforcement reports and product labeling data (see “Drugs,” “Devices,” “Foods“). It currently provides an application programming interface of information that was previously unavailable or easily-accessible to the public, including millions of reports submitted to the FDA from 2004 to 2013.

History

The U.S. Department of Health and Human Services identified “Open FDA” as a priority in its open government “Plan Version 3.0.” Led by the FDA’s Office of Informatics and Technology Innovation, the project began in March 2013 and launched a public beta in June 2014.

Timeline

• March 2013: Taha Kass-Hout named FDA chief health informatics officer.
• March 2013: Work on openFDA begins.
• July 2013: White House Presidential Innovation Fellows join to support openFDA development.
• December 2013: FDA creates the Office of Informatics and Technology Innovation lead by Kass-Hout.
• June 2014: openFDA launches in beta.

Quotable

“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 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.”

– FDA Chief Operating Officer and Acting Chief Information Officer Walter S. Harris

“In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get 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 and browse through a database – all slow and labor-intensive processes.”

– FDA Chief Health Informatics Officer Taha Kass-Hout

Developers

• API
• Terms of service
• GitHub
• Sample use case: ResearchAE.com

Connect

• Twitter
• StackExchange
• Email

References

• openFDA
• FDA’s Path Forward for Open Data and Next Generation Sequencing by FDA
• OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data
• FDA launches openFDA to provide easy access to valuable FDA public data
• Introducing openFDA
• 5.4 Open FDA
• Achieving our Mission through Enhanced IT Service Delivery
• openFDA launches open data platform for consumer protection