Warning Letters Double or Spin?

According to a headline of a Reuters article from last week "FDA Ad Chief Says Drugmaker Warnings Double".  Well, the FDA certainly can't be held responsible for what other people write, but the headline does not quite ring true.  At the very least, it is a statement that requires some "fair balance" in order to convey an accurate picture.  One might even say that such a claim "broadens the indication" of the FDA's enforcement actions in 2009.  

The article states that the FDA sent out 41 warning letters in 2009 compared to 21 in 2008.  Firstly, on a small point, some of these were not warning letters, but were technically notice of violation letters. But more importantly, 14 of these letters were sent on the same day, regarding paid search ads. Whatever one's feelings about that particular enforcement action, one thing is clear – such action was an anomaly that clearly skews the picture when talking about enforcement actions.  While 41 letters is a technical doubling, it does not tell the complete story.  

The article also states that 9 letters have been sent out in January, however, the CDER's DDMAC list of enforcement actions only lists 4.   Perhaps the others have not yet been posted, but if there were 9 issued in one month, that would represent a surge.  

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