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.   

 

Second OPDP Letter of 2021 - Previous Communication Leads to Heightened Surveillance

It didn't take OPDP long to issue its 2nd letter of the year.   This time it was a warning letter to Cooper Surgical for its promotion of PARAGARD” (intrauterine copper contraceptive).  

This letter had familiar aspects to it seen in previous letters from OPDP:

• Resulted from a complaint through FDA's Bad Ad program
• Followed another letter to Cooper Surgical about the same product in 2019
• Concerned a video that mentioned the company and product name and had both inferred and real claims about PARAGUARD but did not have any safety information.
• Video was not submitted under cover of Form 2253 at time of first use
• As a warning letter it required Cooper Surgical to do corrective action

The letter also had some interesting aspects to it:

• The first footnote of the OPDP letter implied that OPDP first saw this video on October 5, 2020 and last accessed it on February 12, 2021, the same date as the letter sent to Cooper Surgical.
• The letter invited Cooper Surgical to contact OPDP if it wanted to discuss OPDP's concerns and to provide evidence that the video was not violative

SUMMARY

On the surface, this letter represents to just represent low-hanging fruit for OPDP. It points out that receiving an OPDP letter places the company, in general, and the product that was the subject of that letter, specifically, under heightened scrutiny for future promotion.   But there is more to this letter than that.

Looking a little deeper it also interesting that both the 2019 and 2021 letters to Cooper for PARAGUARD resulted, at least in part, from complaints through the Bad Ad program which could imply that HCPs are looking at a company's ads more closely after an OPDP letter is issued.   

Also, the description of the violations in the most recent letter to Cooper (no ISI, no submission to OPDP) could imply that Cooper either did not know about this video or that they thought that it was educational and non-promotional.   There have been other examples in the past where a company did not know that a TV commercial had been produced and that the agency that produced it might not have understood FDA regulations on fair balance, etc. required in a drug promotional ad (e.g. Rozerem TV ad).  There are also examples where companies have included reference to a drug in an otherwise educational piece which, of course, rendered the entire educational piece promotional e.g., (Ovide letter).  

It is not clear so I cannot speculate on these possibilities but it is hard to believe that a company could have received an OPDP letter on a TV ad for PARAGUARD and, about a year later, knowingly produced/approved another TV spot that was so obviously violative, as well.   My guess is that there has to be more to the story than what is evident from the letter.

It is also intriguing that this video was viewed by OPDP four months before the Warning Letter was sent out.   Historically it has taken longer for Warning Letters to be issued as they required extra review within FDA before they are sent out.   The interesting part is that the violation was discovered under one political administration, but not acted upon until the next political administration took over.   As I said in my last post this is a trend that will have to be watched in the future as it is my impression that the previous administration believed that FDA was, and should not be, putting up too many roadblocks to the pharmaceutical industry.   Although the number of OPDP letters issued in a given year can vary dramatically from other years and, whenever this happens there has been a lot of speculation regarding trends like this, it is generally not known if there is, in fact, any real reason for this or if it is just yearly variation.  As I said, it will be interesting to watch in the future to see if the trend in an uptick in OPDP letters continues in 2021 and into 2022.  

Finally, although it might not mean anything, it is interesting that OPDP invited Cooper not once but twice in the conclusion to the recent letter to contact OPDP if they wanted to discuss this.  Invitations like this are generally part of the boilerplate language in some OPDP letters but this time that language just struck me as being slightly different in tone than previous times I have seen it.

Hopefully this analysis was helpful to you.