FDA to Make Adverse Event, Recall Data Available to App Developers

FierceBiotechIT

February 12, 2014

When Beth Noveck arrived at the White House she had a clear, albeit unusual, mission?to apply the transparency and collaboration of the open-source movement to government. Noveck has now left the White House, but the ideas she brought are still percolating through the governmental machine. In 2014, the thinking is set to lead to a new, more open FDA.

Regulatory Focus reports the agency has quietly created a website and initiative called openFDA. At this stage the project is still in the prelaunch phase, but the FDA has already given a teaser of its plans. When the program opens for beta access later this year, users will gain access to structured data sets as application programming interfaces (API) and raw downloads. The ultimate scope of the project is unclear, but for now the FDA is working on making three data sets available.

The three data sets will give users unprecedented access to FDA archives of adverse events, product recalls and label information. Together the three data sets represent a substantial slice of what many people want to know about the FDA. The adverse event database contains details of millions of side effects and medication errors, while the recall information the FDA is preparing to share gathers all the public notices of products withdrawn from the market.

Making the data available as an API?a way for machines to talk to each other?means third parties can use the information as the basis for apps. The experience of the National Aeronautics and Space Administration (NASA) gives some indication of what might happen once the FDA opens up its data. One year after making its data available as an API in 2011, NASA began holding an annual Space Apps Challenge. At the event, people create apps and APIs.

Some challenges have no obvious use for NASA, such as a project to make a 3-D printed model of the dark side of the moon from NASA data. Others could clearly be the starting point for technology used by the space agency. In one challenge, teams were tasked with creating a miniaturized modular research satellite for use on Mars. NASA is working to the same White House digital playbook as the FDA. How the FDA interprets the broad goals in the drug regulation arena remains to be seen.

Copyright © LexisNexis, a division of Reed Elsevier Inc. All rights reserved.  
Terms and Conditions    Privacy Policy

Quality News Today is an ASQ member benefit offering quality related news
from around the world every business day.

ASQ is a global community of people passionate about quality, who use the tools, their ideas and expertise to make our world work better. ASQ: The Global Voice of Quality.