Back in 2010, FDA’s Office of Prescription Drug Promotion issued a proposed rule spelling out when a major statement in a consumer ad is “clear, conspicuous and neutral.” At the time, the agency weighed a mandate that the major statement in TV ads be presented in both audio and video, as is required under FTC TV ad standards—a requirement the agency refers to by the shorthand “dual modality.”
Now, research by Merck, which collaborated with OPDP on a study, bolsters the case for such “dual modality” audio/video risk statements. Merck created three versions of a TV ad for a fictitious cardiovascular drug, Sitacor (imvastatin). A control version presented risk info in voiceover only, while a second also featured selected keywords and phrases in text and a third featured the full text of the major statement scrolling at the bottom of the screen. Researchers screened the ads online for a total of 1,440 men and women 35 and up who had been diagnosed with heart disease or had had a heart attack.
The study found no difference between the various formats in product comprehension or recall of possible benefits of the drug, but recall of correct risks was significantly higher in those with visual as well as audio presentation. Ditto for recall of who should not take the drug (women who are or may become pregnant). Intriguingly, noticeably larger numbers of those who viewed the ad with scrolling risk info said they’d likely ask their doctor about the drug and that they would look for additional info about the drug and/or the disease.
The study found no evidence that dual modality either hurt or enhanced recall and comprehension of product benefits, the company noted.
“In this study, regardless of dual modality format, dual modality increased recall and understanding of risks,” said Merck’s Sandra Kerr, head of the company’s Office of Promotion and Advertising Review, in a letter to FDA. “Dual modality did not decrease consumer recall and understanding of product benefits. In addition, dual modality did not impact consumers’ ‘intent to act.’ For example, it did not affect their likelihood to ask their physicians about the advertised product, or to seek additional information about that product. It also did not affect consumers’ likelihood to look for additional information about the condition the advertised medicine was intended to treat, or information about the risk of developing that condition.”
