If you’re not a regular reader of the Federal register, you might have missed the August 6th notice that the FDA is moving forward with plans to evaluate “distractions” in consumer ads. The experimental study will analyze everything from the placement of text to competition between audio and visual elements, and the use of “major statements.” FDA has opened the proposal for comments until September 5th.
According to the FR, "Data from this study will provide useful information for FDA as it considers whether it is appropriate to develop guidance to help improve how broadcast ads present a prescription drug's risks and benefits."
The FDA will create ads for a fictitious brand to treat high blood pressure to control for participants' prior experience and attitudes. Participants in the study would be men and women age 40 years and older. Everyone will be presented a series of ads—each with different tone, neutrality, and presentation of risk information.
As the terrific Crystal Rice (aka “FDA spokesperson”) told Pharmaceutical Executive Magazine, "We chose high blood pressure as the condition because it is chronic and under-treated, and there are few DTC ads currently running.”
And here’s what I had to say:
"Just like no two people respond the same way to a medication—everyone doesn't respond the same way to advertisements," said Peter Pitts, president of the Center for Medicine in the Public Interest. "The most important thing that DTC advertising does is drive people to their doctor's office to talk about a condition. Whether they glean three, six, or 12 contraindications from a commercial because a child is or is not running through a field of daisies is interesting, but not important."
The complete Pharmaceutical Executive story can be found here.
Okay, I overstated. It is important. Mea culpa. Fair balance and adequate provision serves a useful purpose. (Really!) But, when we consider the social science that’s been done surrounding, for example, the Brief Summary, that “purpose” requires closer examination.
Consider the peer-reviewed study that appeared in Drug Information Journal (Vol. 41, pp 111-127). It found that, when it came to print DTC, “As the number of side effects listed (4, 8, or 12) increased, more consumers recalled no side effects correctly (37%, 45%,, and 53% respectively).” The complete paper can be found here.
(Full disclosure: I am one of the authors of this paper.)
So let’s say, for matter of discussion, that we could devise a method whereby every viewer of every DTC television commercial fully understood everything detailed (you should excuse the expression) in the fair balance/adequate provision.
Is that a good thing or a bad thing?
Well, since better understanding of risk/benefit is, um, better – it should fall into the “good” category, right?
But what if this enhanced understanding results in decreased visits to physicians? Is that a good thing? (According to FDA research, about 6% or all doctors’ appointments are scheduled because a consumer saw a DTC commercial.) What about the undiagnosed conditions uncovered during these appointments. (According to FDA research, in 6% of those DTC-generated office visits, a previously undiagnosed condition was discovered.)
Will the new FDA study capture data that speaks to the increased or decreased likelihood of visiting a physician based on more or less complete recall of risk information?
That’s important context -- particularly since the results of this new study are likely to be highly (shall we say) "media worthy."
Hopefully, the research protocol for this study will be discussed at a future meeting of the agency’s Risk Communications Advisory Committee.
