FDA MedWatch Alerts – Up or Down?

The Health Section of today’s Washington Post runs a story called "Why All the Drug Alerts?  Step-Up Signals FDA Bid for Renewed Trust" which focuses on the uptick in FDA safety alerts about drugs.   The uptick that the Post notes was based on a new drug safety warning almost every week for the past three months.  It is, says the article, a manifestation of the agency’s attempt to demonstrate that it is on the job to its critics. 

I used to think that too.  In fact, two years ago, I did a little "look back" at FDA MedWatch Alerts and saw a dramatic increase.

In 2003 there were 108 MedWatch alerts.

In 2004 there were 160 MedWatch alerts.

In 2005 there were 300 MedWatch alerts.

But in 2006, the number dropped back down to 120 and in 2007, barely an increase to 157.  In fact, what the Post is terming as an "uptick" is in fact, a downturn when looking at MedWatch alerts.  So far, this year, there have been 19 issued. 

That said, there is a point that bears repeating.  In terms of the agency image and its restoration, something about which the agency seems to care very little, it is true that in order for the agency to regain ground in public trust, almost inevitably it will have to do so at the expense of industry.  And while the current commissioner does not see it that way, in the wake of the current election cycle, it is likely that a new commissioner might. 

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