Warning Letter Summary thru Third Quarter 2010, Part 2 – the Qualitative Look

J0385349 A few weeks back, I posted the third quarter numerical report on Warning Letters and Notice of Violation letters issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC).  In that accounting, I reported that there were a total of 9 letters issued for the third quarter, which was in error.  There were only 7 as I had inadvertently counted 2 additional letters from the fourth quarter.  I have since corrected that post.  This is why I never chew off the eraser tip on a pencil….

In fact, there were 7 letters issued during the quarter to 6 companies (one company had two separate letters involving two separate products).   

In any case, today (finally) we are taking a look at the actual reasons for the regulatory actions on the part of DDMAC.  What triggered a response from the agency?

The communications vehicles were mostly represented by the usual suspects – a few brochures, a leave-behind sheet, a few patient videos and a journal ad.   However, also this quarter, came the first action letter from DDMAC aimed specifically at a social media vehicle – the Facebook "share" function.  That one has had a lot of commentary and none better in my opinion than that produced at the time by Wendy Blackburn and so I will not re-hash it here.

Looking to the violations themselves, there were four primary categories:  Overstatement of Efficacy, Superiority Claims, Omission or Minimization of Risk Information, and a Broadening of Indication.  And, among the 7 letters issued, all had Overstatement of Efficacy and Omission or Minimization of Risk Information as a cited violation.  So let's look at a few of the activities that triggered DDMAC action in those two categories.

The most interesting lessons come from examples where DDMAC found an overstatement of efficacy:

  • One manufacturer offered this – If you didn't hit your target after being on the maximum dose of the drug for 30 days, there was a money back guarantee.  DDMAC had a few problems with that.  First, the term "guarantee" might carry an implication of efficacy over other brands that don't offer such a condition.  But also, the likelihood of achieving control over one's blood pressure would depend on a variable factor – the baseline blood pressure that the patient has upon beginning therapy.  As baseline pressures increase, the likelihood of success decreases.
  • Another manufacturer used the term "remission" in materials that referenced the goals of patients seeking treatment for depression.  DDMAC took the use of the term to imply that one could achieve "remission" through use of the product.  However, remission was neither a primary or secondary endpoint in studies used to support the product's clinical experience. 
  • It would seem that one of the easiest ways to trip a regulatory wire in overstatement of  efficacy is in the use of patient testimonials used in video.  That is because patient's say things that would appear natural in the course of normal speech, such as in one video saying "I feel fantastic.  I haven't felt this good for 50 years…"   But of course, the product is not indicated for making one feel better than one has in 50 years. If a patient is going to be used in a video, there has to be great care taken to relay the experience of the patient to be extremely – almost literally – reflective of the product label.  Another example of a patient testimonial for a product quoted a patient demonstrating the impact of the product on her quality of life by relaying the impact it had on her grades.  Here one has to take care that one does not demonstrate an outcome that is not only inconsistent with the label, but is an outcome of the effect that the product may have.  The impact of the treatment that is at all removed from the clinical effect is quite possibly going to result in scrutiny with the aim of determining whether there has been an overstatement of efficacy.  

As stated above, each of the letters also contained minimization or omission of risk information.  Here the most interesting takeaway again inv0lved the use of patient testimonials conveyed by video on a Web site.  In the video, five patients relay their experience with the medical product, but the risk information was not present in the video.  Rather, the risk information as conveyed at the bottom of the Web page on which the video was present, in a read0only text format.  Risk information need to be conveyed with prominence and readability comparable to the efficacy presentation.  In other words, it would appear that if the efficacy is stated by a person on a video, the risk information should also be stated by a person on a video and one should not divide the mode of conveyance of the two.

That's it for this quarter.  The year will be over before we know it!


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1 Response to Warning Letter Summary thru Third Quarter 2010, Part 2 – the Qualitative Look

  1. Ellenhoenig says:

    A look at FDA warning letters thru 3rd Qtr-always the 3 usual suspects

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