FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

Regulatory NewsRegulatory News
| 02 June 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of.


The initiative, known as openFDA, comes in the wake of a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public.

"Today's amazing mix of cloud computing, ever-smarter mobile devices, and collaboration tools is changing the consumer landscape and bleeding into government as both an opportunity and a challenge," explained a 2012 report accompanying the White House memo.

"To build for the future, the Federal Government needs a Digital Strategy that embraces the opportunity to innovate more with less, and enables entrepreneurs to better leverage government data to improve the quality of services to the American people."

The core of the report was focused on what are known as APIs. No, not active pharmaceutical ingredients—application programming interfaces, standardized data formats which specify how various pieces of software communicate with one another.

Open APIs would hypothetically allow people to access the raw data FDA puts out through its various databases—approvals,  adverse event reports, recall notices, etc—and repurpose them, potentially making them easier to use or more enjoyable to read.

In January 2014, FDA quietly announced the addition of a new webpage, open.fda.gov, which it said would soon "offer easy access to FDA public data and highlight projects using these data in both the public and private sector to further regulatory or scientific missions, educate the public, and save lives.”

The site, FDA wrote, would soon provide "API and raw download access to a number of high-value structured datasets, including adverse events, recalls and documentation like structured product labeling (SPL) data.

openFDA Launch

True to the agency's word—and prediction that it would launch in the early summer of 2014—FDA has now formally launched its openFDA webpage. And while the page is still in its infancy, projects highlighted on the page indicate it could be a powerful tool for healthcare and regulatory professionals alike.

Take, for example, a highlighted report on adverse drug events. FDA data indicate that reports have steadily been on the rise since 2004, when they numbered around 10,000 per month. By January 2013, they peaked as high as 80,787 per month before dropping off in subsequent months.

But that's a high-level look at a common problem. FDA's data allows users to get considerably more specific, drilling down into types of adverse event reactions (e.g. hypertension), the types of reports (e.g. by manufacturers or the public), the seriousness of reactions, the demographics of the patient, and even the reactions reported.

The site also indicates that users can set search parameters for particular drugs, which may be useful for keeping track of adverse events associated with newly approved drugs.

Benefit to Industry: Fewer FOIAs

FDA Chief Health Informatics Officer (CHIO) Taha Kass-Hout said there will be another obvious benefit for regulatory professionals: fewer Freedom-of-Information Act (FOIA) requests. "In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of FOIA requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes."

The new system will allow for this data to be obtained far more easily, Kass-Hout said in a statement.

While the site is intended to make it much easier to obtain adverse event and other regulatory data, it's clearly not for technological novices. But for those with sufficient know-how, FDA's site is full of advice on how to make full use of the agency's data, work with APIs,

Future data will focus on medical devices and food products, FDA said on the website.


openFDA website


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found