The FDA wants to study DTC tactics

A screengrab from Bristol-Myers Squibb's advertisment for Opdivo, and an example of superimposed text.

The FDA wants to investigate the nuances of direct-to-consumer advertising, by studying the effect of superimposed text on DTC ads as well as consumer perception of animated characters.

The agency announced Wednesday it will take public comments on a proposal to study the effect of superimposed text, or text placed over an image, on viewers' understanding of a DTC ad.

One example of superimposed text is in Bristol-Myer Squibb's recent DTC ad for cancer drug Opdivo. In the television spot, dubbed Longer Life, the benefits of the drug are cast on buildings.

See also: BMS CEO defends use of DTC to promote cancer drug

The FDA, which regulates prescription drug advertising, wrote that it's unclear if previous findings about superimposed text on ads “extend to DTC promotion of prescription drugs and are applicable over 20 years later when viewing promotional materials using today's modern technologies,” like tablets, according to a notice published in the Federal Registrar.

That earlier research is from the late 1980s and early 1990s. It found that larger text was associated with higher rates of comprehension.

The notice also pointed out that earlier research on “supers” was “conducted with populations (i.e. undergraduate students) that are not representative of today's prescription drug users.”

See also: Bill to ban DTC adds to industry's woes

The FDA plans to study the effects of the so-called supers by having participants watch a fake DTC ad and examine their reactions, and then gauge how much they recalled by answering questions.  

The agency in March proposed studying the use of animated characters in DTC, such as the walking intestine used in Xifaxan's Super Bowl ad. The FDA wrote that “personifying animated characters may interfere with message communication.”

The FDA's proposals come at a difficult time for DTC. Sen. Al Franken (D-MN) and Rep. Rosa DeLauro (D-CT), have separately introduced legislation that would eliminate the tax write-off for DTC advertising and impose a three-year hold before those ads can air, respectively. In November, the largest US physician group, the American Medical Association, voted in support of banning DTC outright.