FDA to Test Risk Info with Mock Ads

FDA released a flurry of information last week pertaining to risk assessment, but the one notice that generated a ton of buzz on the Internet concerned a proposed plan to gauge consumers' attention to risk information in consumer television ads by using mock advertising in focus groups.

According to a notice dated August 6, FDA's Department of Health and Human Services 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.

"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 notice stated.

FDA spokesperson Crystal Rice told Pharm Exec on Tuesday that FDA would 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.

"We chose high blood pressure as the condition because it is chronic and under-treated, and there are few DTC ads currently running," Rice said.

The study will cost approximately $165,000, and FDA will work with an outside media company to create the ads. FDA has opened the proposal for comments until September 5. Some industry pundits, however, feel that the study is too broad and might not really prove anything.

"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."

He also noted that the demographic sample used in the study is not broad enough to effectively gauge the viewing habits of the entire US population.

Rice said that it is possible that FDA might run additional studies in other demographics, but that all depends on resources and the outcome of this study.

Peter Zamiska, EVP, CCO of advertising agency Noesis told Pharm Exec that that regardless of whether or not creative interferes with a fair-balance message, consumers are in some way immune to these messages.

"I don't think that they resonate; they are all generic in their sense of urgency and sense of severity of the side effects," Zamiska said. "I think we are doing a fairly reasonable job. But in the end, the FDA should make the final rule that a particular piece of creative has crossed the line."

Zamiska's hope is that FDA would consider running a study that would determine once and for all the value of risk information in advertising. "I want to know the relative value of the risk information, not whether or not they can hear it," Zamiska said. "I bet the population would be against it because it is unnecessarily frightening and often doesn't relate to the individual."