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.