Happy Holidays! As another year comes to a close we share with you our most popular blog posts of 2017. Enjoy!
By Brian Overstreet on March 24, 2017
It’s been an exciting week for drug safety with articles in both USA Today and FiercePharmaexamining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years. We were thrilled to see Advera Health featured prominently in both of those articles.
Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain. One of the biggest limitations is that not all adverse events are reported. As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded. This is different from a controlled clinical trial where all adverse events and outcomes are recorded. Read More
By Brian Overstreet on April 21, 2017
FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16th. By Monday March 20th, our team had run the data through our proprietary RxFiler optimization process and the de-duplicated, cleaned, and properly cataloged data were onto our Evidex platform and ready for use by our clients.
For the fourth quarter, we processed 310,222 new unique case reports, which brought the total new unique case reports for 2016 to 1,253,464.
While a full analysis of our Q4 findings is still pending, it’s clear that the sheer volume of case reports continues to grow rapidly.
Our infographic below provides some key details: Read More
By Jim Davis on March 10, 2017
On March 6th ICER released their final Evidence Report on Multiple Sclerosis medications. The conclusion was that every MS medication, except for Lemtrada, do not provide enough value to justify their prices. As with every ICER report that is released, the pharmaceutical manufacturers refute the findings and tout their R&D expenses and the very real burden of bringing life saving drugs to markets.
I’m not looking to start a debate on the merits of either ICER’s or the manufacturers’ arguments in this post. Taking my position on the fence, I can say that I believe ICER provides a valuable, independent view into value, but at the same time pharmaceutical companies should expect to be able to be reasonably compensated for their efforts. Read More
By Jim Davis on February 2, 2017
The United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.
I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march. The division was obvious. Read More
By Jim Davis on May 12, 2017
If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA. Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. Read More