Warning Letter Summary thru Second Quarter 2009, Part 2

Yesterday we examined the quantitative aspect of the warning and untitled letters from FDA's DDMAC – today we are going to look at the substance of the letters to discern any lessons learned.   And just for the record, the letters from this quarter cited activities that included a wide span of communications – from the spoken word at conferences to video to mailers.  

  • Sponsored Links – It goes without saying that the most extraordinary aspect of the quarter was DDMAC's issuance of 14 letters on April 2 covering promotion of 45 brands that had sponsored links on Internet search engines.  There are multiple lessons from these letters and the issue has been much explored on this blog.  But a key takeaway among many is that just because a promotional practice like these sponsored links may have been long-standing, it should not be implied that a lack of action on the FDA's part suggests regulatory acceptance of that practice.  The wheels move slowly.  Secondly and obviously, sponsored search engine links are not perceived by FDA to be within regulatory parameters.  
  • Superiority ClaimsWhen making a superiority claim, it is imperative that the claim be supported by "two well-designed, head-to-head clinical trials comparing appropriate doses and dose regimens…"
  • Placement of Risk Information in Videos – FDA considers risk information that is placed in the seventh minute of a seven minute video lacks prominence to balance the benefits that are extolled during the first six minutes.  Unfortunately, while DDMAC states that this was not within regulatory paramaters, the agency fails to state in the letter what would be an acceptable remedy or solution.  The safest course is to ensure that one has includied discussion of risks blended with any discussion in the video that is describing benefits.  But video content that describes benefits and runs a trailer of risk information is not likely to pass muster.  
  • When a Reminder Ad Isn't – When using a double entendre in an reminder ad, one may be inadvertently making a claim – which reminder ads do not permit.  One manufacturer used a tag line that could be open to two distinct interpretations.   A reminder ad can state name, but no indictaion.  To quote Arnie Fried – "If one reasonable meaning makes this a reminder ad, and the other reasonable meaning makes it a promotional ad, then the ad needs to meet the more stringent standard."

Those were the takeaways from this quarter.  
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