Less Equals More

Posted on October 10, 2007 by Mark Senak

Here is a brief update on the pattern of Warning Letters issued by DDMAC to companies for violations in promotion.  As you can see, the numbers under the Bush Administration have seriously declined, as pointed out frequently here on this page.  This year may be the most lackluster year of all and ironically while seeking and getting an increase in PDUFA dollars.  Less equals more. 

YEAR                # OF DDMAC WARNING LETTERS

2007                                               15   (first three quarters only)

2006                                               22

2005                                               29

2004                                               23

2003                                               25

2002                                               28

2001                                                64

2000                                               75

1999                                              108

1998                                              156

1997                                              139

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3 Responses to Less Equals More

  1. emjeff says:
    October 11, 2007 at 9:09 am

    So, what does this mean? A few ideas:
    Explanation 1) The FDA has been warned by W himself (or his evil henchmen) not to send out Warning letters.
    This is the (not so) subtle message behind your post. I really can’t see it. The current gripe with the FDA is that it is not doing enough to protect safety; sending Warning letters out is a way to make the Agency look better, and you can bet they’d be doing much more of it, if not for…
    Explanation 2) The industry is getting better at promoting within the context of the current regulations. Remember that DTC advertising is relatively new and the regulations surrounding it are not the clearest. Companies are learning what works and what doesn’t, what they can get away with and what they can not.
    Explanation 3) DDMAC has learned to concentrate on the most egregious violations, instead of nit-picking. This is similar to 2) , above, except that here it is DDMAC that is learning.
    In my view, Explantions 2 and 3 are more credible hypotheses for your data than “Let’s blame George”. I am sure that you can find stories from DDMAC reviewers all too willing to complain that “My letter to BigBoy Pharmaceuticals was squashed for political reasons”. However,it is really much more likely that it was killed because it was a “nit-picky” issue not worth the bother. No organization is unconstrained by resources, including DDMAC.
    It is your right, of course, to continue to write and believe that W is the puppet-master controlling everything. I will respectfully call you out on it, though, whenever you do so.
    Regards,
    MJF

  2. Mark Senak says:
    October 11, 2007 at 12:48 pm

    Thanks for your comment. I agree that all of your options are plausible, and possible, but I’m not sure they are probable. I think I am a far way away from blaming W for everything, but as I pointed out in a previous post, the track record here for the administration is that there has been great evidence of political indulgence into the workings of government. From Justice to EPA to FDA – there has been a lot of interference, which in this case, makes the concept of Administration interference in enforcement just as plausible as any of the three notions you have put forth. Best, Mark

  3. emjeff says:
    October 15, 2007 at 4:12 pm

    Mark;
    Can you provide a link for that previous post?
    Thanks,

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