FDA wanted to find out what people really think of the risk information printed on the back of pharmaceutical advertising. Surprise, people tend to absorb far less information from the giant blocks of text printed in drab language.

DDMAC social science analyst Amy O’Donoghue explained FDA’s recent study results to an audience of marketers at Drug Information Association’s annual meeting, yesterday.

“We recognize the current situation where pharma can just reproduce risk information written to doctors in print ads,” O’Donoghue said. So, we looked at current format and different ways of presenting the information and what format.”

The first study examined how people use the current brief information to determine if risk info and med condition affect the time people spend reading the ad, the comprehension of the info, the selection of topics, and the intention to ask a doctor.

FDA created a fake drug called Oncazil, which they used to treat asthma, high cholesterol, excess weight and produced low risk ad or high risk ads for each disease state.

Of the 800 people that saw the ad, most of the, were more worried about the heart valve damage risk in the high-risk advertisement. The average reader spent 26 seconds reading the promotion page and 41 seconds reading the brief summary.

“The conclusions we reached are that the presence of a serious risk did not change the time spent on either page,” O’Donoghue said.

In another study, FDA only looked at overweight drugs. They studied the different formats of brief summaries to see which format presents risk info in the most digestible manner.

• Traditional summary has risk info buried in a giant mix of text in three columns, on back page.
• Q&A format has less info and is more of a dialogue.
• Highlights section is more reader-friendly.
• The drug facts box version was designed similar to the OTC brief summary.

This was a mall intercept campaign and was computer administered, however the screen was the size of a magazine page. 300 people were interviewed.

FDA found no difference in reported intention to ask doctor or differences in risk/benefit tradeoff. Self-efficacy differed by format and people who saw the drug facts box were more confident that they understood the risk information than on the traditional summary.

Most people were positive about the drug facts ad box and the traditional received the lowest marks. People had a significantly more positive attitude towards the highlights and drug facts (54 percent).

“People who like a format more might spend more time on the ad and get more out of it,” O’Donoghue said. “FDA hasn’t outlawed any format, but additional studies will be done to determine content of brief summary forthcoming.”