Viewing Video’s Regulatory Profile

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Are you considering putting together a video that contains a patient of physician testimonial?  If you are, you will want to take extra care in considering two things – how you present your risk information and how you script the video.

Looking back through 2005 at the regulatory action letters sent by FDA’s Office of Prescription Drug Promotion (OPDP) – formerly known as DDMAC – one can see that as a communications vehicle, videos have their own issues when it comes to staying within regulatory communications confines.

By my count, since 2005, there have been 235 letters issued by OPDP – covering both Warning Letters (WLs) and Notice of Violation (NOVs) letters citing around 315 different communications vehicles for over 600 violations, including among others, risk omission or minimization, superiority claims, overstatement of efficacy, unsubstantiated claims and broadening of indication.  Here is how those letters netted out proportionally among the various violations and you can see that risk minimization/omission is the biggest category (43%), followed somewhat distantly by overstatement of efficacy (21%) together comprising nearly two-thirds of all violations.

But when you look to video (excluding DTC ads), which are more likely to contain patient or physician testimonials, the proportions change.  There were by my count 15 letters from 2005-2012 (inclusive) citing 35 different violations among these categories, but over 80%, or 4 out of 5, involved risk minimization/omission or overstatement of efficacy.

Placement of risk information in videos has its challenges – putting it at the end like credits to a movie may not cut it.  And when people talk about their own experiences with a treatment, may include reference to outcomes that is not typical or supported by clinical data, making the scripting (and review of the visual representation), extremely important when producing a video.  It is not a bad idea to review all 15 instances of videos and letters to get a good idea of what the regulatory parameters are not only on content, but on presentation.

So in the end, extra care may need to go into putting together and evaluating a video that contains a testimonial before it is put out in the world for our viewing pleasure.