Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 2

J0386036 Ok, last week, I ran a posting that profiled the rate of Warning and Untitled Letter rate from FDA's DDMAC, this week, let's look at the substance and see what, if any, lessons there are to be learned from DDMAC spanning two quarters – the last quarter of 2008 and the first of 2009.  By the way, it is worth noting that since last week's posting, DDMAC has issued 3 more letters.  They are on a tear!

Here is what bothered DDMAC during the first quarter of 2009 – all Untitled letters:

  • "In a world where many OAB drugs are the same… one stands out" – DDMAC found this to be a claim of superiority.  You have to be careful when trying to distinguish a drug by descriptive language.  If you don't have specific data to back it up, you run the risk of a regulatory action.  
  • "No known metabolic drug interactions" – while apparently not untrue, the fact that there are many drug interactions with the specific medication resulted in a claim by DDMAC of an omission and minimization of risk information. 
  • An overstatement of efficacy was claimed by DDMAC for the phrase "Day 1 Relief" because the data upon which the claim was relying was a post-hoc analysis of efficacy data from one clinical study and was not found to reflect clinical experience or substantial data.  Make sure your claim can be backed up by clinical experience and – more than one study analysis performed post-hoc.
  • It seems to be a common perception that one can say that one's quality of life is improved by use of a drug.  Not so.  If you don't have specific data to make this claim (and in fact, that would nearly be impossible), don't make the claim.  Quality of life data is a very specific kind of study.  Quality of life is a broad claim – meaning something tantamount to happiness.  Proceed carefully here. 
  •   A "Pharmacy Formulary Flashcard" that contains only benefit information and no risk information is not permitted.  
  • Claiming a drug has all the benefits of its extended release formula tripped a regulatory wire when the two versions are not bioequivalent.   
  • An oral statement made by a company representative that referred to the fact that the product had a serious warning was a "class effect" was seen as risk minimization by DDMAC. 
  • A DTC commercial got dinged for making a claim that the medication was the only medication that shrank the prostate, when in fact, that apparently is not true.  Oops.   
  • And finally, there was more Internet action as DDMAC took action aimed at five Internet banner ads.  Here a drug with a boxed warning had banner ads with "compelling" portrayal of patients suffering from migraines, but carried risk information that DDMAC found hard to find.  Lesson here – more prominence and balance for risk information.     

That's it for the first quarter of 2009.  I'll go back shortly and post the lessons from the last quarter of 2008 as soon as I can.

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