People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals.
Pew Research has shown that especially for people with chronic conditions, there is a reliance on getting information and support from friends and family and one quarter say that they seek information from people who have the same health condition that they do. In other words, there appears to be good reason for the use of testimonials by patients when seeking to promote a medical product. A patient like me who has faced what I faced and now has been through the experience tells me what it is like, and I may take great stock in what they say.
But while it may make sense, there may be inherent regulatory risks in going down that path – risks that are peculiar to use of testimonials. Why?
Part of the appeal in having a patient describe their experience using a medical product is that they provide a real, first-person description of how the product worked for them and the difference it made for them with respect to their condition. That is also the drawback.
Communications about the use of a medicine are supposed to reflect the label that FDA approved for the product. Going outside of that parameter risks an FDA regulatory action like a warning or untitled letter from the Office of Prescription Drug Promotion (OPDP).
I went through my database of OPDP Warning and Untitled Letters which includes letters from 2004 through today and tracks multiple characteristics of the letters, including descriptions of the communications vehicle (brochure, video, e.g.) and of course, the violations cited. The data base profiles more than 300 letters and over 1000 violations. While not a separate field, when a testimonial has been involved it is noted in the file.
I was able to identify 12 instances in which FDA sent a letter regarding a communication that involved a patient testimonial – in 3 of those instances the patient was also a celebrity spokesperson.
It is noteworthy that the most common violation cited in OPDP letters generally is the minimization or omission of risk information – by far. However, when it comes specifically to patient testimonials, the most common violation was the overstatement of efficacy, involving 11 of the 12 letters.
The basis for that is likely that when a person describes in subjective terms their experience with a medication, it usually includes a reference to the impact the use had on their lives. Phrases such as it “literally changed my life” and “restored my confidence” or describing in personal terms the use of the medication for which evidence does not exist to demonstrate that everyone would have such an experience.
Almost all of the communications vehicles involved video, but it also involved some print.
It also bears reminding that OPDP usually looks not only to an individual statement or action (though that can suffice) but also the entirety of the presentation.
This is not to say that testimonials are bad or should not be attempted, but it does say that one should take care to examine the presentation carefully, with particular sensitivity to the issue of overstatement of efficacy and to take note of historical examples where FDA has acted.