The FDA recently announced that it would explore if there are better ways to help the average American understand and absorb risk and safety information in DTC advertising, especially television, which still gets the bulk of DTC spending.  

The FDA wants to know if providing risk information the way it’s done now in DTC ads interferes with comprehension. The agency plans to assess this by testing different versions of ads that include varying amounts of risk information and then measure people’s takeaway.

After years of dallying with guidelines in this area, the FDA has finally asked a question that is worthy of debate and exploration. In fact, we think the agency isn’t going far enough in the scope of its questions. The FDA should also be asking whether this message content should be communicated at all entirely in television. And in evaluating different content approaches, they might look at an effective warning example from another industry sector that we think could serve as a model.    

Those of us who have worked for years in healthcare communications know a few things about DTC advertising: first, we know that consumers generally tune out the part of the TV ad that follows the promotional message and that very few people ever read the bottom, let alone the back, of a DTC print ad. Years of DTC advertising (and comedic spoofs of it) have led consumers to believe that most prescriptions drugs will do one of four things: kill them, give them a 4-hour erection, bestow on them the uncontrollable runs, or present a problem if they are taking an MAOI, whatever that is.

If you ask most people to name the specific risks or side effects of the drugs they themselves take, they may get one or two points right, but consumer recall is typically very poor. The format of 30 seconds (or often longer) of successively scary facts does not result in a learning moment. It’s too fast, it’s not specific to you, and it’s accompanied by pretty visuals of a couple and a dog walking happily on a beach. You take away almost nothing.

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In fact, research also indicates that the current format is not even that effective in influencing consumer behavior. We are aware of examples of companies testing different versions of the same commercial—with and without certain significant warnings or possible side effects—that learn that there is no statistical difference at all in people’s intent to ask about the drug. This suggests to us that perhaps consumers listen to the warnings, but decide that these are issues to be discussed with their doctor. So it doesn’t impact their action, or worse, people are completely tuning the warnings out. And that’s too bad because consumers want, and need, to know risks and side effects.   

So, is there a solution? And is it one that can work not only in TV commercials, but across the full range of media channels that comprise today’s media mix? From a message point of view, can we get consumers to remember what they hear and to hear it correctly? And from a behavioral perspective, can we help them to absorb and internalize the warnings and engage with their doctors to assure that they are using drugs as safely and appropriately as possible?  

We believe there is a model for this already. It’s the warning on cigarette packs. Ask a consumer what the risks are of smoking, and they will accurately replay risks to their lungs, risks to pregnant women, risks to their gums and teeth, and even the risk of death.  

The message is short, serious, encompassing and effective. Because all brands carry the same message, one that has been repeated over and over for years, there is concentrated and cumulative impact.

And that’s exactly what should be done with DTC. Imagine if every ad for a prescription ad carried a standard warning. For the sake of argument it could be: “All drugs carry certain risks and should not be used by everyone. These risks can range from inconveniences to the risk of death. You should talk to your doctor to determine your specific risks, reasons you might not be a candidate to use this drug, and any side effects and warnings that may pertain to you personally before you take it. To learn more visit”  

The FDA wants people to know and take away all risks that it calls “serious” or “actionable” (i.e., a symptom they can recognize or know and therefore go about resolving). Paradoxically, we believe that DTC television viewers have a better chance of knowing and understanding those risks by being less specific about those risks in that media. A more general warning, as proposed above, encourages consumers to engage in a personal discussion with their doctor about a drug, and it promotes engagement with longer-format printed or digitally-delivered information. It’s those media that allow a consumer to really absorb the specifics of each drug and what it might mean to them.

Standardizing the warning in this way and using media appropriately is a modern, responsible and rational approach. And one the FDA should also entertain.

Julieta Smith is group strategy director at McCann HumanCare.