Last week, FDA launched openFDA—its new, open government initiative. Created in response to an executive order on transparency, openFDA will provide access to many of the agency’s health data sets. FDA is encouraging developers of websites and mobile medical apps to process FDA’s health data so it is more useful for the public, clinicians, and researchers.
On June 2, 2014, the agency published a database with millions of drug adverse event reports—the first step for openFDA. While adverse event report records were previously available under the Freedom of Information Act (FOIA) or by downloading large amounts of encoded files, the process of obtaining them can be slow and difficult. The openFDA database makes the adverse event reports easier to access and search using an Application Program Interface (API). “OpenFDA will make our publicly available data accessible in a structured, computer-readable format,” wrote Taha Kass-Hout, Chief Health Informatics Officer of FDA, in an openFDA blog post.
FDA’s hope is that pharmaceutical companies, researchers, and software developers will use this information about adverse events to identify emerging public health concerns. FDA has stated that it will not release any data that could be used to identify individuals or reveal other private information.
Software developers and mobile app developers might have new opportunities to process and package the information in ways that consumers can use and understand. For example, developers could create a mobile medical app that allows consumers to learn whether other users of a drug have suffered the same adverse events. (For information about how FDA regulates mobile medical apps, see our e-alert from September on FDA’s final mobile medical app guidance.)
OpenFDA’s adverse event datasets could be mined for numerous types of uses. Drug companies will have easier access to adverse event statistics. Consumers could obtain more information about adverse events occurring with drugs they are taking or might take. Lawyers might mine the dataset for use in lawsuits involving adverse effects of prescription drugs. The pharmaceutical industry is said to be “cautiously supportive” of the openFDA initiative, but urges that patients should receive information about a medicine in the context of both the benefits and the risks.
In the next few months, FDA expects to release additional information to openFDA, including records related to product labels and recalls of all FDA-regulated products, including medical devices. We will continue to follow the evolution of openFDA.