The agency will investigate how prescription drug product perceptions are impacted by the inclusion of price comparison information and supplementary contextual information in advertising geared at consumers and health care professionals, amid concern that the impression remains that price is the main factor to consider.
As noted in the FDA’s Federal Register notice announcing the study, in prescription drug advertising, drugmakers are allowed to include “truthful, non-misleading information about the price of their products in promotion” — which extends to price comparison information. However, when drugmakers include information about the price of a competing product to make advantageous claims, they should also include the context that the drugs being compared may not be comparable efficacy- and safety-wise and that the presented prices don’t necessarily reflect the actual prices paid by consumers, pharmacies or third-party payers. However there’s concern that the inclusion of contextual information about efficacy or safety doesn’t do enough to correct the impression that the products are interchangeable and that price is the primary factor to take into consideration.
The OPDP said its “greatest interest” related to this study is to investigate whether the inclusion or absence of price comparison information and contextual information has an impact on outcomes such as perceptions of comparative safety and efficacy, impressions of the comparator product, and intentions to seek additional information about the advertised product.
Participants in the study will be consumers self-identifying as being diagnosed with diabetes and physicians who are general practitioners and specialists. In its responses to comments, the regulator specified that it’s using a fictional product for the study, though the comparator is a real product. The study will measure participants’ experience with medication for diabetes, prior exposure to advertising for the comparator and prior experience taking the comparator. The OPDP also said that while it would be informative to broaden the study to examine a variety of cost information, a lack a resources makes this impossible, and so the price comparison will be for the same indication on a yearly basis.