This past June, the FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers and the public to access large, important public health datasets collected by the agency.
According to the agency, the initiative is the result of extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests.
And this week the FDA unveiled a new Application Programming Interface that offers data from the agency’s database containing medical-device adverse event reports, going back to 1992.
The crowd-sourcing of adverse event data may or may not yield interesting results, but it’s a good place to start. It represents an opportunity for the agency to begin designing a more evolved approach to 21st century pharmacovigilance.
For the rest of the story see OpenFDA: The Key To Moving Pharmacovigilance Into the 21st Century in the new edition of PM360.