FDA gut-checks DTC clarity

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In addition to sussing out how healthcare providers perceive direct-to-consumer ads, the Food & Drug Administration is giving consumer information the once-over, this time to see if the copy agencies and drug makers have been sweating over is meaningful for patients.

The key issue in this study is composite score, which averages individual endpoints for products. The FDA is going to use an allergy medication label in the study, and in this context, the composite score would take into effect the drug's impact on symptoms such as runny noses, congestion and sneezing. The regulator says what might get lost is that “although a drug may have a significantly better score overall, it may not have a significantly better score on a particular aspect,” like sneezing. FDA says the goal is to come up with labels that will make this greater-than-less-than equation more obvious, and also notes that there is little research indicating if the current state of affairs is working.

The agency wants to know:
  • If consumers understand what a composite score is/means
  • If consumers understand how efficacy is measured
  • If DTC ads with composite scores influence drug perception
  • If presenting composite scores in a different way will improve comprehension and decision-making

The study will come in two parts. First, consumers will be presented with ads and asked questions to assess their understanding that a composite score was used and how the efficacy and perceived risk relate to the scores. Composite scores will then be explained and subjects will be asked a new round of questions to see how this additional information affects how they understand the drug.

The second round of testing will focus on the most effective way to explain a drug's efficacy. Variables will include product indication with no mention of a composite score (“Drug A treats and helps prevent seasonal allergy symptoms”), indication plus symptoms, and indication, composite score and explanation of what the score means (“May not be as effective in addressing each factor individually”).

The test also veers into analogy territory, with one section presenting the efficacy concept as a race. The agency gave the following example: “Drug A's effectiveness is based on a composite score. A composite score is like a decathlon. In that event, athletes compete in 10 events . . . an athlete may not win all events, but if he or she performs well enough in some events, he or she may be the winner” based on a combined score.

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