One of our company-wide New Year’s resolutions in 2016 was to stop using our blog as a forum to lambast FDA.  It was getting boring, tiresome, and repetitive. While we know these blogs are well read within FDA, we also know that nothing we write here is actually going to move the needle on issues of drug safety in Silver Springs, MD. 

“Just when I thought I was out, they pull me back in!”
Michael Corleone, Godfather Part III (you know, the only decent scene in the whole movie)

I am proud that I had held my tongue all the way through the first three months of the year.  But then Medscape decided to blow the lid off FDA’s criminal failure to report quarterly watchlists of drug safety issues for the past 15 months.

Yes, that’s right - FDA was actually in violation of the law for the better part of 2015 (and 2012-2014 depending on how you read the law) by failing to post quarterly lists of emerging drug safety issues.  Medscape does an excellent job of digging into this issue, so I won’t get into the details here, but I strongly recommend reading the full article, linked to above.

This revelation wasn’t a surprise to us at Advera Health.  We actively track and monitor FDA’s safety watchlist reports in order to benchmark those issues against our own early warning system, RxSignal.  When we noticed that the website had not been updated, as required by law, in June of 2015 we started asking FDA questions.  The response was typical – nothing.  Or, more specifically,

“I apologize for the delay. I am consulting the FAERS team regarding your inquiry and appreciate your patience while we look into this.”

Why is this a big deal – a big enough deal to force me to violate our company’s New Year’s resolution? 

It comes down to this: if FDA isn’t going to fulfill its most basic duties of informing the public about emerging safety risks, then what do they exist for?  Are they really so “captured” by big pharma to the point that they only exist to approve new drugs and help spur their growing profits, as a large contingent of people believe?

I’m not one for conspiracy theories, so I refuse to believe that – but when we see situations like this clear failure to fulfil obligations, my resolve starts to break down.

It is no secret that FDA is understaffed and underfunded.  As such, I’m willing to give the organization a lot of leeway. But in this case, it is very hard to attribute this breakdown to the “poor government” excuse.  It is not that hard for FDA to look at their own adverse event reporting data and identify emerging safety issues.  Using similar methodologies, we do it every day at Advera Health.

Take this issue raised from the Medscape article as an example:

“The US Food and Drug Administration (FDA) has an early warning system to help catch safety problems with drugs after they reach the market. In the second quarter of 2015, a class of diabetes drugs called SGLT-2 inhibitors showed up on its radar screen….The public didn't know about this blip until about 7 months later. By law, it should have known months earlier… Based on FAERS reports received during the second quarter of 2015, the agency identified stroke and thromboembolic events as a "potential signal of a serious risk" for seven SGLT-2 inhibitors.”

To summarize, FDA found out about specific risks with widely used medications and they didn’t notify the public about it until 7 months after the fact.  That’s pretty bad. 

What’s even worse is that here at Advera Health, we started warning our Evidex platform clients about the same issue in June of 2014, when our RxSignal analytic was triggered to Active status and users were alerted. A full year before it “showed up on FDA’s radar screen” and 18 months before their very tardy report was issued. You can read a full analysis and summary of the Type 2 Diabetes medications, here.

Was that magic?  Did we invert the space-time continuum, engage the flux capacitor, or slip into a time loop that enabled us to see the future before it played out in this timeline?  While that would be awfully cool, the answer is no.  We accessed exactly the same data FDA does, we cleaned it up, and we analyzed it using our own proprietary signaling tool, RxSignal, which has now been peer reviewed and published in a major journal showing its accuracy above 74% of the time.

This is all great for our clients.  They found out about the stroke and thromboembolic event risk in SGLT-2 inhibitors a full 18-months ahead of FDA’s public notification.  That enabled them to make better drug purchasing and prescribing decisions that may have improved patient safety and saved their organizations from significant long term medical care costs.  But what about the vast majority of the patient population that doesn’t yet have access to our data and tools – either directly or indirectly?  They’re still at the mercy of FDA’s disclosure time table.

When FDA can’t follow the law and make sure they are disclosing those risks in a timely manner, we all suffer.  As mentioned above, I don’t subscribe to this being a grand conspiracy to inflate pharma company profits by keeping safety issues in the dark.  As a good friend of mine in politics once said to me, “don’t ever assume conspiracy and cunning by a government agency when their actions or inactions can be explained by incompetence and bureaucracy.”  I’ve become accustomed to incompetence and bureaucracy, but when it rises to the level of negligence in clear violation of the law, I really start to grow concerned.

So, if you are interested in finding out about emerging drug safety issues even when FDA can’t be bothered to tell you about them, click here for more information.


Brian M. Overstreet, President, Advera Health Analytics, Inc.


Topics: Drug / Indication Information

Brian Overstreet

Written by Brian Overstreet