OPDP Finds another Kardashian sister in their 3rd letter this year

 OPDP sent out their first untitled letter (3rd letter overall), in a letter dated Monday, March 8th.   

This letter, sent to Biohaven Pharmaceuticals about their migraine medication Nurtec ODT, involved a testimonial interview with Khloe Kardashian.   Not lost in the irony of this letter is that in 2015 Kim Kardashian was the testimonial-maker in her tweet about how effective Diclegis (Duchesnay Pharmaceuticals) was at treating her morning sickness.  

These two testimonials had a lot in common

• The testimonial-giver presented their own experience which was way above average for what would be expected with the drug they were prescribed. (overstatement of efficacy)
• There were inferred comparative claims
• Both letters were due, in part, to a complaint to FDA's Bad Ad Program.

The most recent letter also had some other elements in it not in the previous letter:

• This testimonial was a video (not a tweet like in the first letter)
• This video was designed to be promotional as it had ISI at the end
• This video was not submitted to OPDP at time of first use.

The main things from a Regulatory standpoint, that were important about this letter were:

• The testimonial contained numerous overstatements of efficacy (e.g., time of onset of action) and comparative claims (e.g., nothing else had worked or only worked for a short while)
• Single words like "gamechanger" represent significant superiority claims
• The ISI was at the end of the interview in small letters which were on the screen for 4 seconds and was preceded by a statement by the moderator ("we'll be right back") that would infer the end of the interview.  So , instead of a callout (signal) that the ISI was coming, the ISI was minimized, similarly to when a press release puts ### above the ISI.
• Failure to submit a clearly promotional piece at time of first use. 

The first two bullets are typical of many OPDP letters in the past and point out the problems with using testimonials.   The spokesperson is not just giving their opinion.   Their words actually become promotional when linked to the manufacturer of drug or even, in some circumstances, with the disease state if that testimonial is tied, in some way, to the product class.  Normally what I have found is that a good testimonial agreement is a good place to start with someone giving the testimonial.   This agreement should note that the product exists in a highly-regulated industry and that company has the right to modify or not use the testimonial if they feel it is overly and unduly promotional.  People who give testimonials rarely understand the guard rails that companies must operate in so inclusion of language in the agreement about what is appropriate and what is not appropriate is always helpful.  

The 3rd bullet talks about minimizing the ISI.  Use of "supers" to point to the ISI at the end and to point out the limitations of use in the product are very helpful in balancing the claims.   Also, if care is taken to avoid statements like "we'll be right back" and other signs that the video content has ended that would help.   

The final bullet, failure to submit under cover of Form 2253, is interesting.   Research I have done shows that when FDA says this they don't always mean that the piece was NEVER submitted.   It also can mean the piece was submitted late compared to when it was first used.   The examples I found had pieces that were submitted to OPDP anywhere from 30 days after they were first used up to 5 years after they were first used.    In this case, as with other cases like this, it is impossible to tell how long it was after first use the piece was submitted to OPDP, if at all.

As a final note, normally videos like this are pulled by companies soon after the OPDP letter goes out. A quick search of YouTube and social media found the following videos that were still up today (March 11th) that contained claims from Kardasian on Nurtec.  Not all of them were company-generated but, normally, this is all cleaned up immediately after OPDP issues a letter like this.   Interestingly, not the case in this situation.

Khloé Kardashian Has Suffered from Migraines Her Whole Life - YouTube

If you google you can also find promotional Twitter and Facebook postings/videos that contain some of the same claims (e.g., 15-30 minute relief) that were mentioned in the OPDP letter.   At least at this point, Biohaven has not removed this information from the internet.   Time will tell to see if it is/can be removed.