The arbitrary reviewers at FDA have decided that Otezla and Toujeo have music that is disturbing the peace. They have knocked on the walls of Celgene and Sanofi by issuing letters saying their television ads violate the law. How do they know they broke the law?

The beauty of the FDA system is they decide what is distracting. They don’t need to have any objective consumer based evidence of distracting music or rapid scene cuts. I have no doubt these ads pump up the music and fun. The problem, for all of us doing DTC is these two ads are fairly routine for DTC and similar ones have been on air for years. The letters are surprising and must represent some internal decision to get tough. Maybe they are being criticized for lax enforcement because the number of warning letters and untitled letters have come down.

So, they decide to force the drug maker and agency to pull the ad, spend a small fortune re-shooting or re-editing. Judge, jury and executioner. Nice system. Evidence, they don’t need no stinking evidence.

I have seen these ads for months and never once did I think, wow, these ads are distracting and must violate a host of FDA regulations. I guess any ad with music and happy people is now under the scrutiny of FDA reviewers, who apparently have decided to crack down on happy people dancing. I know some in Congress want to go after happy DTC people having sex, but I digress.

As you can tell I do not think much of FDA’s evaluative process. These type of ads have been in vogue for years for many brands. So how slow and low must the music be, how slow the cuts from scene to scene, how long must the supers be? Is dancing limited to one actor, two? None of us know because FDA can decide what is a violation. I am sure Celgene and Sanofi can discuss it with FDA before the sentence is carried out. They have as much chance of a reversal as appealing to a North Korean court after insulting the great leader.

FDA should be forced to have real quantitative research data that supports what they say in their letters. Maybe at the very least a panel of consumers can be brought in to screen ads FDA thinks are problematic. I urge that some system of evaluation be added that can be more objective than a single reviewer. I know the reviewers believe they are acting fairly. I am sure they are bright, hard working folks just trying to do right. But they are arbitrary and inconsistent. That makes it difficult for drug makers to predict how they might react to an ad that is upbeat. For drug makers, what they need is consistency just like we want in an umpire or referee.

Maybe this is FDA getting their last regulatory licks in before the new Trump sheriff comes to town. More letters can be expected if this is how they will approach DTC ad review. Even after 20 years in DTC, the FDA can still surprise me.