Warning Letter Summary - Third Quarter 2008, Part 1

Even the most casual observer will have noticed that across the board, under the Bush Administration, there has been a drastic curtailment by domestic agencies in the enforcement of regulations.  Critics and policymakers have assailed the track records of several agencies.  The Federal Election Commission lacked membership.  The Environmental Protection Agency has been cited for not acting to protect clean air, to name a few.  The Food and Drug Administration has been no different, as I've noted here many times.  The Division of Drug Marketing and Advertising (DDMAC) at the Center for Drug Evaluation and Research (CDER) track record demonstrates how enforcement has declined, despite the fact that PDUFA dollars have gone up:

YEAR                # OF DDMAC WARNING LETTERS

2008                                               13  (first 3 quarters only)

2007                                               20   

2006                                               22

2005                                               29

2004                                               23

2003                                               25

2002                                               28

2001                                                64

2000                                               75

1999                                              108

1998                                              156

1997                                              139

But what is extraordinary about 2008 is that, despite the fact that there have only been 13 letters issued by DDMAC this year, a whopping six, count 'em SIX letters were issued in one week and FIVE of them were in a single day.  What's that about?

Part 2 of this posting will come either later today or tomorrow, and will examine any commonalities among the letters that might indicate a new pattern by FDA.  Or, what we may be seeing is that as the sun sets on this Administration, non-political appointee employees are ramping up enforcement again, so that these agencies may once again be fulfilling their mission to a degree not seen for the past 8 years.  That might signal a slew of such letters to come in the coming weeks, and most certainly, I would think, in the next Administration.

Comments

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I realize that the actual number of letters titled "warning letters" vs. untiltled letters has gone down over the years. I was under the impression that several years ago, DDMAC changed how they issue these letters in that they no require legal review prior to issuing communications to Pharma concerning promotion violations. Can you identify the number of untitled letters this group has sent out regarding same? I would believe that not all violations first come as a "warning letter".