The US Food and Drug Administration (FDA) has launched openFDA, a programme allowing web developers and researchers to access “massive” datasets on adverse effects and to use them to build their own applications.
The agency said it envisaged mobile developers using the information to create a smartphone application which patients could use to compare their drug adverse effects to recorded incidents.
OpenFDA uses a search-based Application Program Interface (API) to collect public health data, allowing computer developers to search text within that data, “ranking results much like a search using Google would do,”said the FDA. This search function lets users 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.”
FDA spokeswoman Andrea Fischer told Outsourcing-Pharma.com applications using openFDA will be hosted outside the FDA site by the groups that create them.
“Thus, they can query openFDA for specific public data (such as all reports in a specific timeframe) and get results returned to them in a machine readable format that they can then parse in their own system.
“By using this approach, FDA can keep the data up-to-date without developers needing to download the entire dataset each time an update is published.”
No more FOI requests
The FDA’s Chief Health Informatics Officer Taha Kass-Hout said the data sets had always been publicly available, but accessing them had been difficult, either through Freedom of Information Act (FOIA) requests or by downloading large amounts of files encoded in various formats.
The new site is free to use and allows the public to pull “massive amounts” of data “instantaneously and directly from FDA datasets in real time on an ‘as-needed’ basis.”
Drug adverse events is the first dataset available, using reports submitted from 2004 to 2013. The pilot will later be expanded to include the FDA’s databases on product recalls and product labelling.
The data provided through the interface is already in the public domain and the FDA will not approve or reject the applications using its data.