FDA to Make Adverse Event Data Available to Software Developers

The FDA has launched a new initiative—openFDA—that aims to make it easier for software developers to use the agency’s data in their applications. Data from the agency’s Adverse Events Reporting System will be among the first to be made available, allowing for the creation of easily searchable programs drawing on the thousands of reports of adverse medication effects the agency receives each day.

We “hope that this site can be a valuable resource to those wishing to use public FDA data in both the public and private sector to spur innovation, further regulatory or scientific missions, educate the public, and save lives,” wrote Taha Kass-Hout, MD, the FDA’s chief health informatics officer, in a blog post announcing the launch of openFDA. In addition to adverse events, data on product recalls and product labeling will be made available in beta form this summer, with a larger public release expected in the fall.

According to an article in Bloomberg Businessweek, Dr. Kass-Hout envisions the data being used to develop mobile apps that would allow consumers to compare the effects of OTC drugs while they shop or software that would alert pharmacists to a medication recall. Prior to the launch of openFDA, the agency published data on adverse medication events several times per year in a form that was difficult to integrate into applications.