Creating actionable analytics around the big data set provided through the FDA Adverse Event Reporting System (FAERS) is the backbone of the AdverseEvents Explorer software. Given the infrequency of releases in 2013, you can imagine how excited we were when we heard the news that Q1 2013 data were finally posted for download. While probably not surprising, self-described data geeks do get excited about data.

Since the release, the new FAERS data has been run through our 17-step standardization algorithm, RxFilter, and added to AdverseEvents Explorer for our clients to evaluate the drugs, mechanisms of action, classes, and indications that are important to the decisions that they make on a daily basis.

Before we start our ovation, or chants of “hooray for the FDA!”, there is a catch. If you were a subscriber to AdverseEvents Explorer, you already had much of this information, at least for the new and hotly debated drugs, through our Freedom of Information Act (FOIA) requests. That means if you were a subscriber you were already making decisions based on the most up-to-date information available, and were already saving your organization significant costs and improving patient outcomes!

Download Report - Expediting Drug Safety Using FOIA: An Analysis of 57,000 New Unreleased FAERS Reports

Another exciting development for us recently was the further information provided to the public on the OpenFDA initiative. At first glance it sounds amazing. API access to FAERS! Real-time data feeds! Transparency for all! This would be an extremely welcomed change and would significantly enhance the product that we can deliver to our clients. Furthermore, it would help to continue to validate what we have been working on since 2010—the use of post-approval drug safety data in the decision making process.

However, I must say that we are cautiously optimistic that it will deliver what it suggests.

When looking closely at their March 6, 2014 presentation, FDA Path Forward to Open Data and NGS, they suggest ways in which the FAERS data accessed through OpenFDA can be used, however they do not provide any details on the actual API itself. We know how the data can be used. We are using it! Our clients are using it! At the time of this post, OpenFDA has declined to return our calls.

With both the recent release of data, their cooperation with us and the public on FOIA requests, and the OpenFDA initiative, we can’t help but feel that our ambitions and goals with AdverseEvents are being validated. However, we will also hold our applause and praise until we see concrete action that helps shift the balance of power to those that make the drug purchasing and utilization decisions.

 

Related Read: OpenFDA- the Good, the Bad, and the Ugly

 

Be a part of the power shift. Start a free trial of AdverseEvents Explorer and see for yourself how the data can be used. FDA welcome.

 

Freedom of Information Act Request - FAERS Report download



Jim Davis

Jim Davis

Executive Vice President

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Topics: FDA, Evidex, FAERS

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.