 released a flurry of information last week pertaining to risk assessment, but the 

 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 

 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.

 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 

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.

 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."

Articles

News Analysis

Do consumers pay attention to risk information in television ads? FDA plans to find out with a study using phony ads for a nonexistent blood pressure drug.

FDA to Test Risk Info with Mock Ads

 about how to live with Crohn's disease. The online radio shows feature unbranded healthcare information, and are part of Abbott's initiative to communicate directly with patients with Crohn's disease.

"People are going online to get information about all sorts of things, including chronic diseases," said 

. "Podcasting seemed to work particularly well for Crohn's disease."

According to Johnson, many people with Crohn's are first diagnosed between the ages of 15 and 35—a key demographic for podcast users. "It just made sense to create an online educational resource to give patients information in a manner that they are used to searching for."

Topics will range from diet and nutrition to social stigma, relationships, and depression. "These particular topics really resonated with people living with Crohn's disease," Johnson told 

. "These are really key lifestyle issues for things they are dealing on a daily basis."

The series is available only on Abbott's unbranded subsite Crohnsonline.com, which offers general health information about the disease. People interested in learning about Abbott's Crohn's treatment HUMIRA (adalimumab) can click a link that will take them to the branded drug site.

Abbott currently has two 10-minute podcasts on the site, with four more in the hopper. The first features a Q&A with gastroenterologist Dr. David Rubin, the second has an interview with registered dietitian Tracie Dalessandro. Options are available to pause the recording and to download the podcast to a personal media player; however, the podcast cannot be accessed through popular podcast providers such as iTunes.

The assumption is that Abbott—much like other pharma companies dabbling in Web 2.0—does not want the general public to leave comments about drug use on iTunes or other treatment options.

Johnson disagrees, stating that since the podcast series just launched, Abbott is still assessing its distribution options. "In the future, we will certainly look for opportunities to make the podcasts widely available," Johnson said. "Because we are in a regulated environment, we can only operate within a certain amount of space. But as we continue to get response and feedback, we will look at comments in the future. We want to get comments back from people."

 that Abbott's podcasts are a high-quality online offering, but should not be considered social media.

"We are not seeing a lot of advances in terms of social media with the pharma companies that we work with," Newman said. "What this begins to do is create a relationship between a brand and a group of people that want to sign up for it. That's a step in the right direction."

Crohn?s disease is the topic of conversation on the first Abbott unbranded podcast. The company talks about why it went the radio route.

Pharmaceutical Executive-08-13-2008

FDA to Test Risk Info with Mock Ads

Abbott Launches Podcast Series