The FDA on print ads…

horse-cart-450x298POST SUMMARY: The FDA is planning to make it easier for consumers to understand complicated language in print ads and while this is a good first step they need to better understand how DTC ads are actually leading to healthcare decisions.

Simplifying complicated PI language in print ads is certainly welcome, but this is a subjective approach and conservative M L R teams could limit its impact.

I have worked with both conservative and liberal M L R teams and it’s an ongoing process to win approval for DTC ads.  This despite the fact that most people don’t read above an 8th grade reading level and a year’s worth of qual research that indicated that consumers find DTC marketing materials and websites too complicated to understand.


As for the FDA they need to come to the conclusion that a small minority of patients are going to actually ask for an advertised drug without first doing a lot of research, usually online.  The other challenge is that each drug and health condition has unique market properties in the way they lead to an Rx.  An ad for Viagra for example, might not lead to as much online research as an ad for a new diabetes drug.

The challenge for DTC marketers is going to be how much of the PI do we simplify and who is going to do it?  Then they will have to tun M L R teams into editors.  It’s not going to be easy, and while you could pre-clear ads, the shortage of budget dollars at the FDA might make that a lengthy process.

I believe that fair balance is not required on the home page of drug websites but should be one click away from any page of the site.  Website analysis continues to show that safety pages rank among the top 5% of page views and downstream click stream analysis indicates that a lot of people are trying  to get a more simplistic explanation of drug side effects.

I also believe that fair balance in TV spots is unnecessary. I mean people tune out when they here the fair balance and again very few people are going to run to their doctor to ask for an Rx after viewing a TV spot without first doing research online.


The FDA would be wise to subscribe to Manhattan Research and have one of their analyst teams come down to present once a quarter.  They are trying to take a scientific approach to marketing but consumers very rarely make rational decisions.