Tuesday, July 21, 2009

FDA Cannot Track Its Own Review of Adverse Event Reports!

I don't know whether to laugh or cry regarding a Government Accounting Office (GAO) report that said while the number of adverse-event reports - which help the agency track drug and medical-device safety problems - increased during 2004 to 2008, FDA officials couldn't provide data about how many reports it reviewed! (See "GAO: FDA Can't Determine How Much Money It Needs".)

I laugh because the pharmaceutical industry's fear of adverse event reports is unfounded! That fear has been the industry's excuse for not transitioning from "interruption" advertising with its one-way monologue from pharma to consumer to "conversation", two-way dialogue, advertising via social media (see, for example, "Finally, a Drug Company Embraces Social Media, AEs Included!"). If the FDA doesn't know if it has reviewed an adverse event report, pharma gets a free ride.

Of course, I cry because the number one priority of the FDA - not to mention the drug industry - is to ensure drug safety. A consistent and fair review of adverse event reports is FDA's main tool for monitoring drug safety after marketing approval.

According to the GAO report:

"The FDA received 522,871 drug-related adverse-event reports in 2008 compared with 426,016 in 2004. Device reports jumped to 588,161 from 189,450 while reports involving biologics also showed large gains. FDA told GAO while they place a priority on reviewing serious adverse-event reports, they receive "substantially" more adverse-event reports than staff can review. The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed."

Compare these numbers to what the FDA recently reported (see "New FDA Data: Adverse Event Reporting Increases Dramatically"). FDA counted 496,412 adverse event reports (AERs) in 2008 whereas GAO counted 522,871, a difference of 26,459. Seems small. but since the FDA does not know which AERs it has reviewed, how do we know there are no serious events among those 26,000 that the FDA did not count?


  1. John,

    What a bunch of crap from FDA. They don't NEED to thoroughly review half a million reports. (Although it would be nice if they had the manpower). With data mining techniques, FDA could easily cluster and categorize reports based on key words and tags and then concentrate on clusters with high hit counts.

    For example, if 50,000 reports contained the keywords "Cymbalta" OR "Duloxetine" (a terribly dirty drug) then FDA would be prompted to drill down on those specific reports to see exactly what is going on.

    Maybe they do analyze smartly. But it would not surprise me if they don't

  2. what's amazing is that I've been able to do this (organize adverse event data) from 1 PC in my basement. yep that's right.


    granted, it's not set up to track which AEs have been 'examined' or not, but this wouldn't be difficult to ask.

    And as SteveM points out, there are many ways to cluster.

  3. I agree that this is potentially systemic weakness. However, there are many different possible explanations. Sometimes AE's are reported more than once. Sometimes updates to AE's are counted as new AE's (and sometimes not). If FDA and GAO aren't aligned in how they count, there will be differences.

    In face, DB-reconcilliation (particularly for AE's) is a very difficult task.

    I also find your thoughts on the social media aspect of this a little hollow. It is so easy to be found guilty of misrepresenting your drug in the current environment....even without hard data.

    Social media will eventually be used in a real fashion by Pharma, but it will be about 10 years after it is common in nearly all other industries....that is the conservative nature of an industry as heavily regulated as pharma.

    E.g, Pharma manufacturing is currently governed by GMPs (good manufacturing practices). However, this is a fairly dated body of regulation. In actual practice, FDA has enforced cGMPs (current)...they are not documented regulations....they're whatever FDA wants them to be at any given point ("current thinking" is the phrase they use to describe this in guidance docs).


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