FDA To Study Direct-To-Consumer Drug Advertisements in Magazines, Other Print Publications

Federal regulators plan to conduct a new study to determine how much risk information needs to be presented in drug advertisements seen in magazines and other print media, as well as where it should be located for maximum and appropriate effect. 

Earlier this month, the FDA posted a notice to the federal register, indicating that it was accepting comments on a study of risk information found in direct-to-consumer print ads. The notice indicates that the agency is accepting public comments until September 13.

The notice was originally posted in June, with a public comment period that closed on August 18. However, the FDA only received a handful of comments before the cut-off Those comments, and the agency responses, are published in the new notice.

The studies appear to be geared toward questioning whether adverse health warnings and side effect risks should appear in both the brief summary portion of the ads as well as in the important safety information (ISI) sections.

The FDA indicates there are questions about whether putting the information in twice has a positive or negative effect. The notice indicates that some research has determined that the repetition can reinforce the memory of important warnings, particularly for older adults. However, the agency is also questioning whether it is possible to “overwarn” consumers, which could result in them ignoring all of the risks.

“One potential downside to including the same warnings in both the ISI and again in the brief summary is the potential to overwarn consumers. Overwarning is the concept that individuals are exposed to so many warnings in the course of daily life that they are less likely to pay attention to any one particular warning,” the notice states. “In terms of presenting risk information, detailing too many risks may lead consumers to discount all risks, or miss the most important risk information.”

The studies were first announced in March by the FDA’s Office of Prescription Drug Promotion (OPDP). Other studies will look at television ads, how drugs are marketed toward professionals, and promotions for drugs that went through accelerated approval processes.