As part of the Food and Drug Administration’s recently launched openFDA initiative, the regulatory agency is for the first time offering an application programming interface providing web developers and researchers direct access to millions of reports on drug adverse events and medication errors that have been submitted to the FDA since 2004.

“The hope is that this API will be useful to developers and researchers interested in FDA enforcement actionswrites Taha Kass-Hout, M.D., FDA’s chief health informatics officer and director of the FDA Office of Informatics and Technology Innovation, in a recent blog. “Developers can now call into the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories, or specific foods or drugs.”

According to Kass-Hout, recalls are reported to the FDA and compiled into the agency’s Recall Enterprise System, and every week an enforcement report is released that catalogues them. He says the recalls database is the second dataset to be released under the openFDA initiative.

So far, the adverse events API has been accessed by 18,000 Internet connected devices, with nearly 2.4 million API calls since the launch. In addition, at least one new website has been created to allow any user to submit queries on the adverse events data, and several other companies are integrating the data into their products and services.

“OpenFDA is taking an agile (development in small chunks of iterations) approach in the creation and release of these APIs, with the objective of getting feedback from developers and researchers (as well as from industry and the public) at the GitHub and StackExchange forums that serve our project,” says Kass-Hout. “We plan to incorporate some of the feedback into future iterations of the API. Accordingly, as we learn more about how the public might seek to use this data--and as a result of our agile and user-centered methodologies--the API structure may change quite a bit in the coming months.”

He also points out that “it’s important to note that this API, like all others on openFDA, are in beta and are not ready for clinical use.”

Last month, FDA launched openFDA in order to make it easier for developers, researchers, and the public to access large public health datasets collected by the agency. The initiative leverages a search-based API to collect large amounts of existing publicly available data, with the ability to search through text within that data, rank results, and to build applications on top of openFDA.

 

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