Pfizer Untitled Letter Regarding Estring

I realize I am a little late to the party on this one as the last few weeks have been busy.  But let's dive in:

Pfizer apparently put a testimonial video together that featured a physician and a patient, both of whom were paid spokespeople for the company.   Although I have not seen the video, the OPDP letter was pretty clear.   The physician and patient spoke on THEIR experience with Estring, basically saying that they saw instant relief with no side effects.  However, as OPDP points out, this does not constitute a fairly balanced presentation of the benefits of the drug AND that these statements by the doctor and patient are, indeed, product claims and so must be presented along with fair balance regarding the risks of using Estring.   The video apparently did not have any risk information and referred the viewer to go to a product promotional website or talk to their doctor to get more information about Estring.

So this is a relatively cut-and-dry violation which once again shows that patient or doctor testimonials are promotional labeling/advertising and need to only be used in the following situation:

(a) when they represent on-label, average performance of the drug
(b) when they are presented with fair balance and access to the PI

For videos on the internet these could be handled by having important risk information and URL of the PI embedded within the video or, on a youtube channel, in the space that surrounds the screen on the youtube channel page.  In addition, you want to have careful training of the spokespeople as to what they are NOT allowed to say.  This does not mean you would tell them what TO say.   However, being upfront with people before a video is shot is much easier than having to try to edit a video after the fact to remove questionable statements.

It seems to me that every once in a while OPDP picks a topic they want to reinforce with the pharmaceutical industry and selects a company with a violative approach to use as an example.  While that may not be true the effect is still present.   This letter reinforces what I always tell clients regarding testimonials and what I tell my clients about testimonials is based on the experience I have gained by looking at past OPDP letters and attending national meetings where these topics are discussed.