How FDA Regulations Stymie DTC Marketers' Creativity: The Symbicort Case Study

You've probably seen the recent Symbicort TV ads that feature an elderly "big bad" wolf with COPD. The commercial, produced by AstraZeneca (AZ), has a line that reads: "Don't huff and puff like the Big Bad Wolf if you are suffering from COPD. Talk to your doctor about using Symbicort to help you breathe better."

Here's the storyline of the ad (see here):

1. The Big Bad Wolf looks longingly at the home of the three pigs.
2. He takes a deep breath and attempts to blow their house down.
3. All he has is a little breath.
4. The Big Bad Wolf is suffering from COPD, Chronic Obstructive Pulmonary Disease
5. So he goes to his doctor and gets a prescription for Symbicort.
6. He is able to blow out the candles at a birthday party.
7. On his way home he passes the home of the pigs.
8. He has an idea, but we do not know where it takes him.

But he does NOT blown down their house. Why Not?

Maybe he's not such a big bad wolf after all?

No, I believe the answer lies with FDA regulations.

I can imagine the agency people and the Symbicort brand team brainstorming ideas. The agency and brand team probably wanted the wolf to blow down the house after taking Symbicort. It may even have submitted this ending in initial storyboards to AZ's medical/legal/regulatory (MLR) department for approval. But the MLR people probably nixed the idea.

The reason?

It wasn't because the AZ MLR department feared a lawsuit by offended pigs or that it thought it might send the wrong message; i.e., that AZ condoned violence.

No, it was FDA regulations that stood in the way. Specifically, if the wolf's COPD recovered so completely from Symbicort treatment that he could blown down a house, the FDA would likely send AZ it a warning letter citing “Overstatement of Efficacy.”

"Couldn't the wolf blow down something else?," asked the MLR reviewer? That would avoid receiving an FDA letter.

It was a conundrum. Here was a perfect storyline that cried out for blowing down the pigs' house in the end, but now the ending had to be changed. So, the team came up with a birthday party where the big "bad" wolf could blow out the candles on the cake or blow a party horn.

In the end, the wolf passes by the straw house of the pigs, doesn't blow it down and a light bulb indicates he has better idea, but we're not quite sure what that is.

The next question: What was the wolf's idea?