Keeping an Eye on Adverse Events

This week, the FDA updated its quarterly reporting on Adverse Events.  It is a bit of a complicated mess to work your way through.  But there are other ways to look at adverse events and given that there have recently been a few drugs experiencing well-publicized adverse events, it seemed like a good subject to explore.

The FDA has  Freedom of Information Act (FOIA) office that processes requests for information.  Among the information that can be requested is a printout of the adverse events for a particular drug, or even those related to a particular company.  When submitting a FOIA, you can specify any parameters.  The only thing you have to do is (1) be patient – it used to take about 6 weeks, but it does vary, and (2) pay for it, but it is not exorbitant and price depends on how lengthy your research is.  Depending on what you ask for, you also may need storage – the reports are computer sheet printouts that can go on for pages, so be careful what parameters you choose.  If you choose too broadly, you can wind up with a LOT of unwanted information and paper.

J0428588But who else is watching?  One more thing about FOIA – it is also sometimes useful for a company, particularly one with a drug having high profile problems, to file a FOIA not only on its own adverse events reports, but to file a separate one asking who is filing FOIAs on your drug’s adverse events reports.  That’s right, you can discover whose looking at your adverse events.  Of what use is that?  Well, I call it the Early Warning System.  First, you can see how many law firms are looking at it.  That can be an indicator of an issue.  Second, you can see if reporters are looking as well.  Lastly, you see anyone else who is looking and you can gauge the level of interest in your drug.   It is not a definitive look, after all, most would use a consultant to file such a FOIA, but it can be illuminating. 

If you are interested in filing a FOIA, or having someone do it for you, you can get information from the FDA Handbook on FOIA or you can see the track record of FDA meeting FOIA requests by consulting the FDA FOIA Annual Report

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