Warning Letter Summary – First Quarter 2008

J0386036For some time, I have been writing about the lack of enforcement coming out of FDA in general and the Division of Drug Marketing and Advertising and Communications (DDMAC).  Well, DDMAC has hit a new low.  In looking at warning letters for the quarter, the division has sent one.  At least we know the FDA is saving money on postage.

The sole recipient this quarter had created a 22 page "File Card" which, according to the agency, presented claims of efficacy without remembering to include full risk information, including the boxed warnings and limited uses of the product, while at the same time making unsubstantiated efficacy claims.  Apparently, the product in question has in its boxed warning issues related to abuse potential, which was not mentioned in the file card.  This, along with the fact that the material also minimized risk and implied a broader patient groups appropriate for the product than were appropriate for the drug was apparently egregious enough for the agency to take action. 

Lesson learned:  Boxed warning information cannot be ignored or glossed over in promotional pieces. 

After the fourth quarter of last year, Eye on FDA compiled a review of DDMAC warning letters going back several years.  Overall the agency has produced far less oversight during the Bush years.  Last year saw a record setting low number of letters for the year.  It would appear this year may set another.  Here it is updated for 2008. 

YEAR                # OF DDMAC WARNING LETTERS

2008  (First Quarter)                 1

2007                                               19

2006                                               22

2005                                               29

2004                                               23

2003                                               25

2002                                               28

2001                                                64

2000                                               75

1999                                              108

1998                                              156

1997                                              139

At this rate, the number of Warning Letters from DDMAC will number 4 for the year.  Perhaps the name of the division should be changed to Doesn’t Do Much About Communications. 

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