June 26, 2023
The National Center for Health Research (NCHR) appreciates the opportunity to submit public comments on the notice by the Food and Drug Administration regarding their Survey on Quantitative Claims in Direct-to-Consumer (DTC) Prescription Drug Advertising.
NCHR is a non-profit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We strongly support the efforts of the Office of Prescription Drug Promotion (OPDP) to protect public health by conducting research to evaluate patients’ understanding of quantitative information provided in prescription drug advertising. We work closely with patients and consumers and are well aware that many people do not understand quantitative claims made in drug advertisements.1 The information collected in this survey is essential to ensure the public is able to comprehend drug information in order to make informed medical decisions.
We appreciate the clear example provided in the notice regarding the type of information FDA is seeking to collect (i.e. claims describing medians). Some of the statements included were clear and direct (e.g., “People treated with Drug X lived for a median of 8 months” in combination with the explanation that “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months”). Research to evaluate patients’ understanding of such explanations will provide crucial information about individuals’ level of comprehension regarding quantitative information.
We strongly recommend that determining patients’ and consumers’ comprehension of information regarding relative risk, absolute risk, relative benefit, and absolute benefit should also be evaluated by the FDA in this survey. For example, how does the public understand a statement that a drug reduces the relative risk of recurrence by 37% or increases the absolute chances of 5-year survival by 3%? Information about relative risk or relative benefit is often used in advertising because those numbers are inevitably larger and seem more impressive than the absolute difference in risk or benefit. According to the FDA’s own research, 65% of physicians believe DTC ads confuse patients about the relative risks and benefits of prescription drugs.2 Unfortunately, patients are not the only ones confused by these statistics.
The FDA notice states that survey questions will be informed by consumer feedback elicited in one-on-one interviews. We support this method of data collection but request that the FDA be more specific about how many interviews OPDP plans to conduct to compile this information, and what type of demographic diversity they will require when selecting people to be interviewed. A relatively small or homogeneous selection of individuals to interview one-on-one could result in unintentional bias in the survey, which in turn would have implications for the results of the estimated 1,100 completed surveys.
We urge you to consider our recommendations, which are intended to enhance the quality of the survey. We would be happy to help recruit patients for your survey or interviews.
1. Sullivan, H. W., O’Donoghue, A. C., Lynch, M., Johnson, M., Davis, C., & Rupert, D. J. (2019). The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements. Medical decision making : an international journal of the Society for Medical Decision Making, 39(8), 975–985. https://doi.org/10.1177/0272989X19875946
2. Food & Drug Administration. (2015). The Impact of Direct-to-Consumer Advertising. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/impact-direct-consumer-advertising