Fewer Letters, Fewer Warning Letters

It may seem that I write a lot about the letters that FDA puts out regarding industry promotion and communication, but that is exactly what the nature of this blog is about. Other things can be interesting, particularly policy developments, but for those who work with medical products and communication, this is the heart of the matter and we have to look for patterns to gain insights.

Since putting together the database of NOV and Warning letters issued by FDA’s Office of Prescription Drug Promotion (OPDP), I have been looking to assess a number of patterns. Sometimes the meaning is obvious, in other’s I am left to speculate.  This is one of the latter.

Every regular reader of Eye on FDA will note that they have frequently seen this chart evolve.  Here is a profile of the combined pattern of Warning Letters and Notice of Violation letters issued by OPDP since 1997 and one will readily observe that the number of such letters experienced a steep decline after the 1990s.  So that is the first point – there are fewer letters than there used to be.

Looking at the same data up close for recent past, here is a more detailed version looking at the period 2004-2012, which is the span of time covered by the Eye on FDA Warning/NOV letter database.

When you break it down between the two types of letters – the more serious Warning Letter (expressed in RED)  versus the NOV letters (expressed in BLUE), you also see that the proportion of Warning Letters has gone down.  So far, for 2013, there are only 4 letters.

So, bottom line, the trend for the number of letters issued has gone down and the trend for the more serious type of letter has also gone down. Cause?  I’m not sure. But would welcome ideas and thoughts from anyone willing to comment.

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