July 3, 2018

What is openFDA?

OpenFDA is the first innovation created by Taha Kass-Hout, MD, MS, upon joining FDA as the first Chief Health Information Officer in March 2013. The goal of the project is to create easy access to public data, to create a new level of openness and accountability, to ensure the privacy and security of public FDA data, and ultimately to educate the public and save lives. The concept was to index high-value, high priority and scalable public-access data, format and document that data in developer and consumer-friendly standards, and make that data available via a public-access portal that enables developers to quickly and easily use it in applications. Dr. Kass-Hout launched the project by obtaining a Presidential Innovation Fellow to focus on policy and programmatic issues in July 2013. The public cloud environment was determined in September 2013, and Dr. Kass-Hout's team solicited agency and user input into policies, first priority datasets, and desirable technical characteristics of openFDA. All the project milestones were met despite the government shutdown.

OpenFDA launched in Beta mode on June 2, 2014, at https://open.fda.gov. It features an open user community for sharing open source code, examples, and ideas. By September 2014, medical device reports, enforcement reports, and drug adverse event reports were available, and every mention of a drug in those reports was automatically augmented with full data from various drug datasets, including codes and label information.

Since its launch, several new datasets have been added to openFDA. For more information about the new datasets, please review the openFDA Updates webpage accessible via this hyperlink: https://open.fda.gov/about/updates/. Also, since its launch, openFDA has been visited by tens of thousands of entities from around the globe and is used by several websites.

What does it do?

OpenFDA provides APIs and raw download access to a number of high-value, high priority and scalable structured datasets, including adverse events, drug product labeling, and recall enforcement reports.

In May 2015, FDA announced the first openFDA challenge to the developer community. For more details regarding that challenge, please see this webpage: An Open Challenge to Tap Public Data.

Who made openFDA?

OpenFDA is an initiative in the Office of Health Informatics (OHI) at the Food and Drug Administration. The core project team consists of the following individuals, in alphabetical order:

  • Letria Hall

  • Denis Krylov*

  • Patrick McConnell*

  • Edmond Mulaire*

  • Jack Finch

  • Ramakrishna Gundala

  • Lonnie Smith

*Contractor to OHI

The team also wishes to thank the following individuals and groups for their contributions to the effort:

  • Gray Brooks

  • Yulia Borodina

  • Roselie Bright

  • Eric Brodsky

  • Robert Califf

  • Sharon Campbell

  • Isaac Chang

  • Ricky Cokely

  • Mildred Cooper

  • Suranjan De

  • Andrea Fischer

  • Janet Gentry

  • Amber Griffin

  • Marni Hall

  • Margaret Hamburg

  • Walter Harris

  • Angelique Hebert

  • Sean Herron

  • Steven Hubbard

  • Iodine, Inc. (Previous Contractor)

  • Taha Kass-Hout

  • Milan Kubic

  • Joshua Lehman

  • Peggy Leizear

  • Randy Levin

  • Jonathan Levine

  • Alan McClelland

  • John Quinn

  • Mark Silverberg

  • Jeff Shuren

  • Jeff Ventura

  • Bradford Wintermute

  • Sean Wybenga

  • Zhiheng (Roy) Xu

  • Carolyn Yancey

  • Kelemework Yimam

How can I join in?

The best place to start is on the API basics page. It provides a great introduction to openFDA and how you can begin developing using the platform. We're also active on GitHub, Twitter, and StackExchange. If there is a unique partnership opportunity or other collaboration you wish to discuss, you can email us at open@fda.hhs.gov.