ISI or brief summary? The FDA wants to test which is ideal for conveying risk info in prescription drug ads. In light of the existing body of evidence on risk, that may be a moot question, some experts contend.

In August, the FDA submitted a proposal to conduct a pair of studies, each with 200 participants, that would use eye-tracking technology to determine how consumers process risk information in DTC print ads. The goal involves seeing how subjects’ attention to risk information fluctuates depending on its inclusion in the “important safety information” (ISI) section or the consumer brief summary.

Including such information in both places may have advantages, the FDA said in a statement, noting research indicating that “repetition of information improves recalls, especially for older adults.” However, a 2002 FDA survey found that “it is possible that risks appearing on the main page in the ISI may be more likely to be read than risks appearing in the brief summary.”

Peter Ubel, a physician and researcher at Duke University whose areas of focus include bioethics and health policy, told MM&M he’s strongly in favor of the agency taking a scientific approach to understanding what people take away from DTC ads.

“I think it’s a really powerful, important step the FDA is taking,” he said, noting that seemingly minute adjustments like font size and the order in which information is presented can make a difference in what consumers take away.

Arthur Caplan, head of the Division of Medical Ethics at NYU School of Medicine, thinks the study misses the point. He said the issue has been studied extensively, so he foresees that it will likely result in regulation. He’s also critical of the FDA studying this area of consumer attention for other reasons. “It’s not like the people who are spending billions on advertising haven’t crafted the message and the timing and the format to do what they want,” he said. “I’m going to put my money on the advertising side with billions of dollars of budget, to undermine whatever the FDA thinks it’s going to do.”

Joseph Turow, a professor focusing on digital cultural industries at the University of Pennsylvania’s Annenberg School for Communication, said the real question is: What are the pharma companies’ goals with presenting the risk information in the first place? One could be to get the consumer to decide whether to use the drug. The second could be to allay the consumer’s fears, despite knowing the drug’s potential side effects.

“My problem with the whole thing is, what do they want to get out of it?” he asked. “Risk can be taken in so many different ways, and the context you place your description of risk has to do with whether you want people to find it more risky or less risky. There’s no way of presenting risk in a way that’s totally neutral.”