Although the pharmaceutical industry routinely employs some of the most creative and sophisticated talent available in the field of advertising, FDA says industry advertisers should be aware of efforts it is making to help. According to Division of Drug Marketing, Advertising and Communications (DDMAC)F social science analyst Amie O’Donoghue, several FDA-sponsored research projects now underway are designed to help maximize consumer comprehension of drug advertising messages. Speaking 9/17 at an FDLI-sponsored Conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologics and Veterinary Medicine Industries, O’Donoghue indicated that practical information gained from these projects could serve to enhance the impact of drug advertising on consumers, and may provide FDA with objective, science-based criteria for evaluating advertising materials for regulatory compliance.

Four basic communication research projects are currently being funded by DDMAC, O’Donoghue said, including: a study on how to improve the presentation of “Consumer Brief Summary” information in print advertisements; a study on how consumers interpret common terminology used in direct-to-consumer (DTC) ads; a study on the role of distracting elements in DTC television ads; and, a study of consumer understanding of clinical efficacy obtained from the display pages of DTC print ads.

The purpose of the “brief summary” project is intended to determine how consumers utilize the brief summary, and what topics that are presented in the summary are most useful to them. Survey data have been obtained from consumers who were approached randomly in commercial malls, located in several cities throughout the U.S., and who were shown several fictitious ads for products to treat such conditions as asthma, high cholesterol, or for weight loss. They were asked what information presented in the ads would be most useful by them, and what other information (if any) they would want to have about the product. O’Donoghue said the agency is awaiting delivery of a final data set from a contractor that conducted the surveys, and analysis of the data is expected to begin shortly. Additional “brief summary” studies are intended to determine consumer reaction advertising statements relating to the frequency and duration of side effects, and to the most useful formats for statements of clinical efficacy.

The “terminology” project has involved utilizing several consumer focus groups to copy-test such phrases that are commonly used in drug advertising as “works fast,” “powerful,” “safe and effective,” and “breakthrough.” Four focus groups in two cities, comprising a total of 40 consumers representing both college- and high school-educated individuals were asked their interpretation of the meaning of phrases common to many drug ads, with an effort by researchers to discern the nature of differing interpretations according to the consumers educational level. Further surveys will be conducted via the Internet with focus groups representing a broader spectrum of ages, ethnicities and genders.

More than 1,000 consumers were surveyed in the project designed to identify how the three components of television ads — visual, audio, and text — interact to affect consumer comprehension, or to result in distraction from the key messages in television ads, such as comprehension of risks associated with use of the drug, and balance between risks and benefits. O’Donoghue said the results of this study, when available should be especially valuable, and there appears to be no other published experimental studies on the occurrence of “distractions” in DTC ads.

The “display page” study is intended to determine how well consumers’ interpretation of drug efficacy, as gleaned from print ads, corresponds to how well physicians believe the product works, based on information appearing on the drug label and their own clinical practice. The study will be conducted in three phases, beginning with four focus groups and in-depth interviews with 40 physicians, including those who are most likely to prescribe the particular drug selected for the study, to determine their expectations for the drug. A second phase will expand the number of physician interviews to 500, conducted through the Internet. The third phase involves Internet interviews with 2,000 consumers who will be asked to describe their expectations for effectiveness of the study drug, based on a reading of the print display ad. O’Donoghue said this study is still in an early stage, as a contract to conduct the physician- and consumer surveys has only recently been awarded.