Aug. 13, 2018 – The FDA released final details about the study it plans to conduct on the effectiveness of drug company disclosures in professional and consumer prescription drug promotion in an Aug. 9 Federal Register notice.

Specifically, the aim of the research is to “examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to both populations,” the notice states. “The purpose of our study is to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims.”

The agency asks whether healthcare professionals (HCPs) and consumers are “able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion.” To address this question, the FDA designed a set of studies that cover both audiences, as well as three presentations that tackle different types of information:

• Scope of treatment (the disease-awareness information to be tested is a disclosure for this condition that focuses on the disease characteristics that the product has been shown to treat);
• Ease of use (the information to be tested is a simple claim of easy drug administration, followed by a disclosure that includes material information about drug administration); and
• Statistical significance (the information to be tested includes a presentation of efficacy analyses, followed by a disclosure revealing that the results of the presented analyses were not statistically significant and should be reviewed with considerable caution).

The construct of the study has each participant viewing three different professionally developed mock promotional print pieces for different prescription drug products that mimic currently available promotion. Participants will see an ad with a weak disclosure, a strong disclosure, or no disclosure; disclosures “will be adjacent to claims and written in font clear enough to be detected.”

The agency will then analyze the results of the scope of treatment disclosures, the ease of use disclosures, and the statistical significance disclosures independently of each other, even though participants will see one of each. The studies will use separate mock promotional pieces for the HCP and consumer audiences and ask “slightly different comprehension questions of each group.” HCPs and consumers will both be recruited from Internet panels.

Further, eye-tracking studies will be done to capture viewing behavior that is different from self-reported behavior. “We will be able to determine whether they looked at the disclosure statement at all, and we can obtain a rough idea of how they looked at it.”

Responding to a comment on the proposed version of this study which stated that the FDA is “conducting too much research without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health,” the agency asserted that “we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission.”

The FDA noted that these aspects are: (1) advertising features, including content and format; (2) target populations; and (3) research quality.

“Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues,” the agency stated.

“Because we recognize the strength of data and the confidence in the robust nature of the findings is improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking,” according to the notice. “We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program.”

The FDA also states that its Office of Prescription Drug Promotion research can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm