If the side effects of so many popular drugs involve “vomiting” and “swelling” and “headaches,” then why are all those people in TV drug ads smiling and cuddling and breathing easier? That is what the Food and Drug Administration wants to know.
The FDA is proposing to conduct a study called “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in DTC [Direct-to-Consumer] Prescription Drug Broadcast Advertising.”
Translation: Do positive visuals in TV ads—smiling, happy people—affect how viewers process the risk information being delivered aurally or via text?
In an announcement of the study online last week, the FDA says that “many assert” that the visuals in ads are always positive during the recounting of the possible negative effects of prescription drugs, leading to a possible disconnect between the warning and the product.
Given that the FDA requires such ads to provide a “fair balance” in the presentation of risks and rewards, the agency wants to make sure the drug ads aren’t distracting viewers from the risk information, saying it does not “fully understand the influence of visual and textual factors.”
“We applaud the FDA for focusing on consumers as it seeks to develop DTC policy,” says Adonis Hoffman, senior VP and counsel for the American Association of Advertising Agencies. “But we question the value of this research effort. This is a study about distractions and it threatens to distract the policymaking community from some of the most important questions.” What questions? Like how much good DTC advertising can do, he says. “For example, how can clear messages about the value of drugs help improve compliance with drug regimes by patients. That’s something they could study.”
New FDA Ad Screeners?
Drug companies are taking a wait-and-see attitude toward the study. Ken Johnson, senior VP of the Pharmaceutical Research and Manufacturers of America (PhRMA), said last week in a statement that PhRMA “generally supports” language in a recent bill that will allow the FDA to hire screeners to review consumer ads before they air and would “fully review” the proposed study.
But he also pointed out that the pharmaceutical companies adopted voluntary guidelines on consumer ads back in 2005, including that “risk and safety information in television ads should be presented in 'clear, understandable language.’” He says the evidence since then is that the ads have gotten “more educational and informative.”
Hoffman agrees. “I think the industry has, for the most part, complied. I don’t see the disconnect between images and copy or video in these ads. Consumers are not ignorant and they listen very carefully to the side effects,” sometimes so carefully to the often-voluminous warnings, he says, that they occasionally forget what the drug is that is being advertised.
The study follows the release of a New England Journal of Medicine report that found that “the number of regulatory actions taken by the FDA against companies marketing prescription drugs to consumers has fallen dramatically in recent years,” though it said that could be due to better industry compliance.