Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 3

Last week I posted Part 2 of the examination of the past two quarters for FDA DDMAC letters.  The week before that, I posted Part 1.  Finally, I am done with Part 3, examining the last quarter of 2008 and mining out the takeaway lessons.  Next quarter I promise to be more timely!  The quarter included violative DTC ads, web pages, patient brochures, flashcards and direct mail pieces.  There were a few important lessons from what was sent out by FDA.  

  • The last quarter of 2008 began with a bang as DDMAC sent out a Warning Letter (as opposed to untitled) to a company that outlined rectifying measures to be taken that included a request by FDA for a plan to convey information that would clear up some of what the agency felt had been misleading.  What prompted such action.  DDMAC sited television DTC ads that it said were misleading because they broadened the drug's indication, overstated efficacy and misbranded serious risks.  How did the company accomplish all that?  Well, first know that the product has a boxed warning – a factor that always makes DTC more risky.  The product, a well-known birth control product, is indicated for birth control and for treating pre-menstrual dysphoric disorder (PMDD), but not the less serious pre-menstrual syndrome (PMS).  Nevertheless, the ad showed women taking on symptoms that could include both conditions, thereby broadening the indication in DDMAC's viewpoint since the ad did not specify PMDD. However, the company did run copy in the ads saying that the product treats PMDD and defining what PMDD actually is.  It isn't like they kept it a secret.  But it seems the FDA wanted the company to definitively state that the product did not treat PMS.  The agency also took issue with the language and images in the ad of women saying "goodbye" to their symptoms, implying that all women were able to progress free of symptoms when, in fact, clinical evidence and experience did not demonstrate that.  That is a lesson in how powerful an image can be and how simple language can have quite complex outcomes.  Lastly, the agency felt that the fast-paced image changes in the ad and the music were both distracting to viewers during the conveyance of risk information – which is another lesson to be learned here.   
  • Another company provides a good lesson on what can make the FDA act when you are talking about an investigational compound.  The company has a compound under study, but DDMAC found they were implying safety and efficacy on a Web page that talked about how the compound worked.  How did they do that?  Well the company characterized the compound on their Website as "well-tolerated" and also described how the compound "worked".  This was not a good idea.  You always need to be careful about how you characterize the way an unapproved compound is supposed to work and avoid any language that appears to imply a claim in any way.  You should not say something is "clinically superior" or "clinically important" because in doing so, you are relying on data that has not yet been validated by FDA review.  If they find the study was poorly done, the characterization of being "clinically important" loses a great deal of its weight.  You should not characterize a drug's "potential" and should not use words like "unique".  In pre-approval phase, you should only report the data, not adjectives to describe it.  

The other letters were confined to rather pedestrian and mostly avoidable issues – like one leaving out some of the important risk information from a patient brochure (really!) and one that left risk information off of a flashcard (happens again the following quarter – note to self – flashcards  are troublesome!) and another that left risk information out of a direct mail piece and broadening the indication of a compound simply by straying from the approved indications in the label.  No real lessons here, just – well – don't do those things.  

That's it.  The next quarter ends at the end of June and the next report will have a review of the infamous 14 Untitled Letters from DDMAC that have created a wealth of issues that need to be explored, both inside and outside the FDA.

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1 Response to Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 3

  1. Joe says:

    ‘cited’ – however you’re the man

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