Many recent FDA warning letters involve what they say are distracting visuals during risk discussion. Last year Otezla and Toujeo were cited for that. A recent study using eye tracking reinforced their view that visual backgrounds on TV ads are potentially hurting comprehension of risks. Drug makers frequently mention some of the risks using supers on screen.

This FDA research completed in 2016 said that consumers do not absorb information well from those supers when there are distracting visuals. Of course, what is distracting is a subjective judgement from the FDA reviewer. My concern on citing drug makers for distracting visuals is the lack of evidence for that specific ad other than reviewer opinion. I understand FDA cannot quantitatively prove distraction for every TV ad they cite and must use informed judgement. I would hope, however, that FDA is consistent between reviewers and does not change over time. In a past column I said I did not think the Otezla or Toujeo ads were any different than many others not cited by reviewers.

The problem with the fair balance requirement is that consumers are bombarded with information that may meet an FDA requirement but not be meaningful in terms of consumer understanding. FDA is studying the potential use of less warning information under the theory that less information may be better absorbed. My concern with this risk presentation is DTC is held to a different standard than every other advertising category for lawful products. Yes, drugs are different than most categories because they can cause harm. I recognize the need for telling consumers that drugs are potentially dangerous. The current litany of risk approach is, in my view, ineffective since a long list is not likely to be absorbed.

The issue is the role of warnings and risks in a television or print ad where time and space is limited. Drug ads are meant to inform consumers of an option for treatment and that is just the beginning of the pathway to prescription. The decision to prescribe any drug is an important one and side effects and risks are important for both physician and patient to understand. My view has been that only the most serious risks with the most harmful consequences should be disclosed in an ad and some quantitative odds should be mentioned. Any more than that is not particularly useful in the ad awareness stage. I clearly would want to know if anyone has died taking the advertised drug and the odds of it happening. I do not really need to hear a litany of possible non-fatal risks at the ad stage.

I hope the drug makers and FDA can work out a DTC risk and warning strategy that meets consumer needs. Consumers should be educated on benefits and risks but fair balance must be re-evaluated in the context of what consumers can meaningfully remember in 60 seconds or one page.