In this country, first you get the data. Then you get the power. THEN you get the insight… That’s why you have to make your own moves.

Not quite the same as Tony Montana’s famous quote in the Brian de Palma classic, Scarface, (money-> power-> women) but the analogy can be made. In Tony’s world, those that control the money, hold the power. In the world of drug safety, those that control the data, hold the power. And not until that balance of power is shifted from a controlling few like the FDA and the pharmaceutical industry, to healthcare decision makers, can true insight be had.

On a regular basis the FDA uses FDA Adverse Event Reporting System (FAERS) data to add drugs to their “watch list”. The most recent additions came last week, on April 21, 2014. Lapatinib (Tykerb), Pazopanib (Votrient), Sorafenib (Nexavar), Sunitinib (Sutent), and certain methylphenidate hydrochloride extended-release tablets (generic products for the trade name Concerta) were all singled out by the FDA as drugs the organization will be keeping a closer eye on. On the surface, this is reassuring. When you dig deeper however, it is clear that the FDA is limiting information flow, thus controlling the power of insight.

The main concern with the watch list is that the FDA is making decisions based on data that is not public, thus no independent source can help put this information into context. They state that these drugs were put on watch based on FAERS data in Q4 2013. The problem is that they have only publically released FAERS data through Q1 2013.

The question is why? The FDA clearly has the data and clearly believes that data has value. If that data is being used to put products on a publicly communicated watch list, shouldn’t the data itself be made public and opened up to outside organizations to examine further?

As I have mentioned in previous posts, there is a changing of the guard occurring in drug safety. With the assistance of smart, easy to use software and analytics, healthcare decision makers outside of the FDA and the pharmaceutical industry have the capacity and capability to utilize big data sets such as FAERS to make decisions. While FDA communications and watch lists are important, they should not be the only communications and watch lists used.

Patient outcomes and avoidable cost burdens to the healthcare system are at risk.

As it seems, the FDA may actually be waking up to this information shortcoming. Their recently announced OpenFDA initiative suggests that FDA will start to make FAERS data available on a more real-time basis. We’ll have to wait and see.

In the meantime, at AdverseEvents we are using every tool at our disposal to get the data, thus shifting the power, and ultimately providing the evidence-based insight that those making everyday drug decisions need to ensure that outcomes improve, and costs are lowered.

See for yourself. Start a 7-day trial of AdverseEvents Explorer.


Jim Davis

Jim Davis

Executive Vice President

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Topics: FDA, FAERS

Jim Davis

Written by Jim Davis

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