The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) announced a study of oncology indications in direct-to-consumer television advertising as these indications are “often complicated and supported by different clinical endpoints such as overall survival, overall response rate, and progression-free survival,” and that may be difficult for consumers to understand. Since the announcement, several drug manufacturers have commented on the proposed study design.
According to OPDP, the study has two objectives: “to determine whether disclosing information about the nature of the endpoints that support the indications for oncology products helps consumers understand the drug’s efficacy,” and “to test whether consumers adequately comprehend indication statements when portions of the indication are presented only in the superimposed text of television ads while other information is conveyed in the audio.”
Since the study proposal was published, several drugmakers have commented on its design. Novartis notes that while it agrees with the FDA’s hypothesis that consumers who are exposed to information in both audio and text will have greater retention of it, “there may not be an opportunity given the time limitations associated with broadcast ads to verbalize the full indication.” Novartis also added that it thinks “it is adequate for the audio portion to present only the most important material information” as the ads are intended to raise awareness and prompt consumers “to seek additional product information by means of asking their health care providers.”
Eli Lilly has concerns that the current study design and questionnaire target a general population of adults as opposed to cancer patients or caregivers who have a different “level of understanding of cancer endpoints and terminology in relation to where the patient is on their journey,” and suggests limiting the study to cancer patients or caregivers. Lilly also pointed out that the current study design assumes that overall survival data is not available. Consequently, any conclusions from the study “are not generalizable to oncology medications broadly and rather would only be applicable to medications that do not have overall survival data available for reference.”
Merck echoed Lilly’s concerns about limiting the subjects to cancer patients or caregivers as they “could reasonably be expected to have a high level of interest in gathering information about cancer treatments.” Merck added that “generating insights from a targeted population may be more strongly reflective of comprehension of those consumers with specific cancer-related experience, which would be a more useful result.” Merck also suggested that OPDP add screening questions to determine whether the participants watch TV and TV advertisements, and how they are likely to view those DTC advertisements. Doing so “may generate additional useful insights into current viewing habits to help inform policy and guidance.”
OPDP has shown a lot of interest lately in regulating DTC advertisements, and this study is another example of that.