The agency acknowledges having little insight into how images and text contained in TV ads affects consumer understanding of the associated risks of the med being promoted. And in a long overdue nod to criticism and concerns, the FDA will undertake a study of 1,020 people over the age of 40 in hopes of gauging meaningful reactions to a DTC ad for a high blood pressure drug.

“Many assert that the visuals present during the product risk presentation are virtually always positive in tone and often depict product benefits,” according to a notice posted today the FDA web site. “A consistently raised question is whether advertising visuals of benefits interferes with consumers’ understanding and processing of the risk information in the ad’s audio or text.”

“The purpose of the proposed study is, in part, to determine whether the use of competing, compelling visual information about potential drug benefits interferes with viewers’ processing and comprehension of risk information about drugs in DTC advertising or with their cognitive representations of the drugs. Positive visual images could influence the processing of risk-related information and the final representation of the advertised drug in multiple ways.”

As Sid Wolfe told the Associated Press, if drugmakers were really interested in conveying risk info, “they’d show pictures of those problems, but you almost never see that.” Coincidentally, the move comes just a few days after a study in The New England Journal of Medicine found that FDA policing of advertising has declined steadily in recent years.

The FDA is also going to examine whether referral text - the words that flash on the screen and direct consumers to read more in a magazine ad - also distracts viewers from more important info being spoken during the TV ad.