One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and insights.
Having tracked Warning and Untitled letters for the years 2004-2015 inclusive (though there have not been any yet this year) in a database, one of the fields noted is the communications vehicle involved in a violation cited by the agency – everything from websites to sales aids to videos and more. The database now has over 300 letters and over 1000 violations.
While there are numerous communications vehicles involved, I chose to look at 4 specific fields: Websites, Video, DTC and Oral Statements. What we can see is that the profile of violations for Websites, Video and DTC are relatively consistent – with risk minimization or omission being the most common violation across the three – when it comes to oral statements, Risk Minimization/Omission is on par with promotion of an unapproved use (PUU – ORANGE SLICE), which had had a very low or non-existent profile with the other vehicles. Other areas that stood out, with DTC there as a much higher profile for making a Superiority Claim (RED SLICE) while in video there was a higher profile for Overstatement of Efficacy (GREEN SLICE).
Websites are obvious – those digital properties where material is posted and refers specifically to printed copy on the Website.
Video refers to video properties that were either placed on YouTube or resided on a Website. If the latter, it was not counted in the Website statistics.
DTC is a broad category and can include print or broadcast.
Finally oral statements are comprised of statements made by various representatives of manufacturers and include sales reps in doctors offices, personnel in exhibit booths at conferences, researchers and even CEOs in media interviews.
There are many insights one can draw from the information and further insights may merit delving further down into the specific examples within each grouping. But clearly communications vehicles tend have different regulatory enforcement profiles. Some vehicles – like oral statements – where you see a greater propensity for PUU – great care needs to be taken to ensure strong messaging and training of speakers. Video also has its own unique profile and clearly the more latitude the means of communication, the more chance there is of making statements that take one into troubled territory. In short, knowing the regulatory profile of your communications vehicle can help you plan and prepare to take steps that might minimize regulatory risk.
