Let's start with the first. The classification of significant postmarketing drug safety issues was not the most intriguing thing I've read. But I was left with a couple of questions, that I hope will become clearer as the Social Media world discusses the new guidance. Section IV.A discusses "The Hazard Assessment". I was struck as I reviewed the section that the summary paragraph was the most important:
When CDER (Center for Drug Evaluation and Research) staff identify a new safety issue, unless the information is derived from a clinical trial or pharmacoepidemiology study, precise and reliable information may be lacking about the frequency of the adverse event or the increase in risk posed to patients exposed to the drug. If such information is lacking, staff will use the existing information on seriousness, and size of the population at risk, and then the modulating factors to classify the TSI (tracked safety issue)
Why the heck is that important? Well, what struck me here is this whole 11 page document does not discuss where the information arises from. Is this solely based on reports from physicians? clinical trial outcomes? reports from patients via MedWatch? media outlets? Or... as I'm thinking... does this include trawling Social Media? You see, patients will discuss their experiences on a drug, and those experiences may include unnecessary positive claims, or adverse events. While an actually trackable adverse event is generally few and far between - I've seen 4 in the last 5 years - there may be information being culled from closed platforms, or by integrating other data sources that CDER may have at its disposal. For me, this is another wakeup call that we need to expand our listening beyond PR-style KPIs such as "We got mentioned 1000 times." into much more in-depth sentiment or human language analytics.
The second guidance document gave me a little food for thought as well. The FDA document discusses the ways in which the body will send out updates about important safety information notices. Section 3, l 197 points out that "At times, decisions to communication about important drug safety issues are affected by information the public has received from sources other than FDA". They highlight media as a source. It's my opinion that this media includes the social type. The concern here, as stated by the FDA, is that the information may be "incorrect, incomplete, or misleading". The communication with the public then, could be justified solely to deal with that type of information.
Okay. I'm not trying to leap too quickly into the breach here. This reads like an invitation. Those who have the authority to correct "incorrect, incomplete, or misleading" information should do so. The rest of this document reads, as much of FDA guidance does, a vague tiptoeing around that how to do so. But, the FDA refers to their mandate as justifiable cause to participate in this correction. An interesting sentence regarding their mandate is found in the Background section, l 51, "FDA believes that timely communication of important drug safety information will give health care professionals, patients, consumers, and other interested persons access to the most current information concerning the potential risks and benefits of a marketed drug, helping them to make more informed individual treatment choices."
My point in highlighting that particular sentence is that the FDA has access to massive quantities of data and safety information. Well, I'm not sure if everybody's noticed, but as Jamie Heywood pointed out at SXSW 2011, Big Pharma has spent large sums to further research and data gathering. Big Pharma has one of the most comprehensive data sets regarding safety for all of their marketed molecules.
What is stopping Big Pharma from correcting "incorrect, incomplete, or misleading" information?
The answers to that question are legion.
Perhaps a better question would be, what benefit can Big Pharma derive from correcting "incorrect, incomplete, or misleading" information?
And the answers to that question move us into the realm of things like trusted partner in providing quality healthcare, acting in the best interest of our business partners, or behaving in a socially responsible manner.
As you all know, that's my drum. Big Pharma has very highly worded mission statements. I believe that those mission statements are achievable. I believe that achieving those mission statements is an ROI all to itself. There are a lot of other relatable KPIs that we could tie to this, like the value of a happy customer, influence of eCOLs or eKOLs, rating high in SEO rankings in the areas of our expertise. These are soft measures, for sure, but I'm sure that our ROI calculations involve lots of tangential soft measures like these.
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