FDA's ability to conduct studies of direct-to-consumer advertising is being impacted by the 2010 census, slowing two pending FDA studies just as the agency is preparing to start three more.

FDA is ready to begin data collection for two studies - one on the use of a toll-free number in DTC television ads to report side effects and one on quantitative methods to present benefit information in ads - but must wait until Sept. 1. The Office of Management and Budget placed it on hold until census workers complete their count of every U.S. resident, reported Amie O'Donoghue, a social scientist in FDA's Division of Drug Marketing, Advertising and Communications.

Studies of the "drug facts" box, on online DTC ads and on disease-awareness information in branded ads are in the early stages of research.

"I will be yet another government official cheering for the census, telling you 'Please, turn in your census so that the response rates will be high and maybe they might even lift the moratorium early so we can get our research in the field," O'Donoghue told the DTC National Conference April 9.

Toll-Free Placement Study Placed On Hold

One of the studies where FDA was ready to collect data was on use of a toll-free number to report side effects to FDA, which was mandated by Congress in 2007 as part of the passage of the FDA Amendments Act.

Researchers want to determine how the toll-free number statement can be placed in a DTC TV ad. It already is mandated for all print ads.

O'Donoghue said Congress' primary interest was whether the statement would detract from risk information and how long it should be. While investigating those areas, FDA also decided to look at whether the statement is noticeable or understandable, she said.

The prominence and placement of the statement also will be tested. The statement will appear before, during and after the major statement of risks in the study, and researchers also will test whether it should just be on the screen or also spoken, O'Donoghue said.

She expects the best placement likely will be after the major statement of risks. "So people have heard the risk information, they've been primed, then they see this statement, which tells them 'OK. Here's something I can do ... about it,'" she said.

Cleaning Up Statistics

The other study where data collection has been halted is assessing the use of quantitative assessments of data on a drug's benefits.

If researchers determine whether quantitative benefit information is useful for consumers, they will look at which formats are best for presenting it in print and TV ads, O'Donoghue said.

When FDA proposed the study last year, it was a signal the agency was becoming more open to use of quantitative elements in DTC ads. It typically had been leery of companies over-relying on quantitative information in ads (¹ Also see "DTC Ads To Be Studied By FDA With Eye On Efficacy Presentations" - Pink Sheet, 23 June, 2009.).

Giving statistics as a percentage, an absolute frequency (a certain number out of 100), or both will be studied. "Some of you may be sitting out there thinking, 'Well of course (combining percentages and absolute frequency in the same ad) would be better,'" O'Donoghue said. "And that may be the case. But it's also possible that it's just too many numbers."

Peoples' understanding of relative frequency (saying someone is a certain number of times more likely to benefit) also will be measured.

O'Donoghue said relative frequency usually is not favored by DDMAC reviewers, but researchers included it to show that method in context with the other numerical expressions. She noted that literature states absolute frequency tends to test the best.

Visual representations of numbers also will be studied, including graphs, pie charts and pictographs - with the idea of testing whether people understand drug benefit information better with numbers and pictures.

"This is interesting for us because we've never looked at the benefit side quite in this much detail," O'Donoghue said. "It will be interesting to see what this does for people."

Other Topics On DDMAC's Research Agenda

Quantitative data presentation will also be assessed in one of the planned studies that are still in the research phase. In the study of the drug facts box, a nutrition facts-style label for drugs, FDA will be looking at various formats for presenting quantitative and qualitative information.

"So if you just tell people ... people had fewer heart attacks on this drug than the placebo [or] you tell them people had fewer heart attacks and you give them the numbers, what kind of effect does that have?" O'Donoghue explained.

Third-party links and their effects on comprehension of risk and benefit information will be included in the online DTC ad study, along with measures of how long it takes people to find risk information on sites and how they use those websites.

O'Donoghue said FDA also will be researching the effects of disease awareness information in branded pieces. She said people may confuse a disease's effects with a drug's benefits when the two are seen in a branded ad.

"If people are unable to distinguish these effects, what kind of presentation techniques can we use to help people understand those differences," she said.

O'Donoghue did not give an update on the contentious distraction study, which is looking at the impact of distracting images in TV ads and whether they affect viewers' understanding of risk and other information in the ad.

Staff are working on the final analysis and still are undergoing internal clearance, she said.

In 2008, DDMAC decided to change the study design for the investigation into distractions, after the agency decided to include more questions about tone and consistency amid an increase in lighter DTC ads (² Also see "FDA Advertising Oversight Will Consider Impact Of “Puppies” And The Internet" - Pink Sheet, 5 May, 2008.).

- Derrick Gingery ( ³ d.gingery@elsevier.com )

Census Delays Planned DDMAC Studies On Various Aspects Of DTC Advertising

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