The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Data Is Everything… Or Is It? Why Data Management Matters

Posted by Brian Overstreet on January 7, 2016

On Wednesday, Jan. 6, Forbes ran an article detailing a 7% drop in the price of Regeneron’s (REGN) stock price.  The company attributed that decline to investors obtaining data from the FDA Adverse Events Reporting System (FAERS) showing eight suicide cases from patient’s taking Regeneron’s new PCSK9 inhibitor Praluent (alirocumab).

The issue, of course, was that the people who obtained those data knew nothing about FAERS or its myriad problems with case duplications, incomplete records, or how to value reports submitted with multiple drugs and/or from dubious sources.

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Topics: Big Data, FAERS, FOIA, Praluent, Regeneron, PCSK9

FDA is Slow so We FOIA

Posted by Brian Overstreet on November 13, 2015

Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government. Federal agencies are required to disclose any information requested under the FOIA unless it falls under one of nine exemptions which protect interests such as personal privacy, national security, and law enforcement.

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How many links does it take to get to the center of an FDA FOIA request?

Posted by Andrea Demakas on July 24, 2014

A Day in the Life of a Data Minion

Ever wonder what magic is happening behind the scenes at AdverseEvents? What goes into the process of data management before it shows up in your inbox, or you receive an email alert about breaking news in pharmacovigilance with data supplied by your favorite drug safety information specialists? Well, there’s a lot. And although it is not all glamorous, we tend to have fun doing it.

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Topics: Big Data, FOIA, AdverseEvents, Inc, faers data

FDA Releases Updated Drug Safety Data – Announces OpenFDA… Now hold your applause

Posted by Jim Davis on March 28, 2014

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.

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Topics: FDA, AdverseEvents Explorer, FOIA

Changing of the Guard - Redefining Drug Safety by Making Big Data Actionable & Predictable

Posted by Jim Davis on January 30, 2014

We have received an amazing response to our report -- Expediting Drug Safety Using FOIA: An Analysis of 57,000 New Unreleased FAERS Reports.

With the release of this previously unavailable data, pharmacy directors now have more information at their finger-tips to make better drug formulary decisions regarding newly approved drugs. Clinical pharmacists can now better pinpoint why their patients are experiencing certain ADEs. And drug safety industry followers can now utilize quality, standardized, and ACTIONABLE information that improves outcomes and lowers costs.

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Topics: FDA, Big Data, FAERS, FOIA

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