FDA Warning Letters on the Decline

by Mark S. Senak
EyeOnFDA.com



The very day after posting about the upcoming FDA meeting on PDUFA IV, I was getting ready to check out the Warning Letters for the 4th Quarter when I decided to look back on the DDMAC issued letters going back to 1997. It revealed something rather astonishing. At this time, while FDA is asking for more PDUFA funds for enforcement, the number of Warning Letters issued by the FDA has drastically gone down over the course of the past 6 years. In fact, the number of letters issued for 2006 hit a new low and was about 1/6th of the amount issued in 1998 when there were far fewer dollars raised from PDUFA fees for enforcement.

2006 -22

2005 - 29

2004 - 23

2003 - 25

2002 - 28

2001 - 64

2000 - 75

1999 - 108

1998 - 156

1997 - 139

As an interior decorator I know would say, "less is more". Perhaps back when DTC was new, there were more violations, but the irony still persists that the FDA is seeking more for DTC enforcement with this track record.

While I don't swear by each of these numbers (they were hand counted and I'm not an election official from Florida), the bottom line is that the number of Warning Letters issued by DDMAC has clearly diminished over time, with some months of the 1990's producing nearly as many letters as some years during the 2000's.

I'm interested in your comment.


(This article was published by BioHealth Investor with permission of the author Mark S. Senak of EyeOnFDA.com)


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