Pharmaguy's Insights Into Drug Industry News

Is the number of warning letters low because pharmaceutical marketers have learned to be more compliant with FDA regulations or is there some other reason?

Could it be that pharma marketers have become more compliant with FDA regulations because their MLR people became more assertive after many major pharma companies, which do a lot of drug marketing, were fined billions of dollars for inappropriately, and in some cases illegally, promoting prescription drugs?

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.

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.

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.

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.