Last month, the U.S. Food and Drug Administration (FDA) announced that it is seeking approval from the Office of Management and Budget (OMB) to move forward with conducting a study of consumer perceptions of disease information included in branded prescription drug advertising. Specifically, FDA states in its announcement:
Sponsors may choose to include disease information in their full product promotions. Such information is designed to educate the patient about his or her disease condition. However, in some cases a full description of the medical condition may include information about specific health outcomes that are not part of a drug's approved indication. The current project is designed to determine if providing such information in branded full product advertisements affects perceptions of the product.
When broad disease information accompanies or is included in an ad for a specific drug, consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement.
FDA gives the example, among others, of mentioning disease consequences in branded consumer advertising that go beyond the approved indication of the drug product, such as “Untreated diabetes can lead to blindness, amputation, and, in some cases, death” (suggesting, for instance, that the product will prevent blindness). FDA’s study will examine disease information provided in branded advertising for three specific conditions: chronic obstructive pulmonary disease (COPD), lymphoma, and anemia.
In August 2011, FDA first announced its intention of conducting such a study and received only one public comment in response to its announcement. Stakeholders now have until July 20, 2012 to submit comments on FDA’s planned study. FDA plans to include a total of 4,650 participants in the study, accounting for variables such as responses from participants who were previously diagnosed with a condition versus those who are newly diagnosed. The study will look at intended participant behaviors following exposure to disease information presented in branded drug advertising.
What moving forward with this study means for industry is that FDA is focusing more closely on disease information included in branded consumer promotional materials and that it may use the results of this study as support for future enforcement actions. Nowadays, companies frequently provide disease information within their branded consumer materials, believing that the presentation of the former is distinct from the latter. Drug companies would be wise to undertake a review of all current consumer-facing branded promotional materials to assess whether the disease information presented discusses consequences or outcomes beyond the scope of approved product indications. This FDA initiative supports a return by industry to maintaining a clearer separation between branded promotional materials and unbranded disease awareness materials, rather than the hybrid materials increasingly in use today.
Julie Tibbets is a partner in the Food, Drug, & Device/FDA Practice of Alston & Bird LLP and can be contacted at julie.tibbets@alston.com or (202) 239-3444.