Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

Regulatory NewsRegulatory News | 05 September 2019 |  By 

As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints.

And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to OPDP’s research.

As the promotion of oncology products increases on television, back in June, OPDP announced studies to better understand 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,” while the second “is 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.”


Novartis told FDA that although it agrees with the agency’s hypothesis that consumers who view an ad with material information in both audio and text “will have greater retention of that information, there may not be an opportunity given the time limitations associated with broadcast ads to verbalize the full indication.”

And while stressing that the primary objective of DTC television ads “is to raise product awareness for consumers to seek additional product information by means of asking their health care providers or through adequate provisions fulfilled by manufacturers,” Novartis also said it thinks that “it is adequate for the audio portion to present only the most important material information of the indication with superimposed text for additional context.”

Both Merck and Eli Lilly suggest that FDA limit the studies to cancer patients or caregivers.

Lilly, which also offers FDA a series of changes to its wording, said it has “some concern that the current study design and questionnaire target a general population of adults versus cancer patients or caregivers who have a different level of understanding of cancer endpoints and terminology.”

Lilly also takes issue with FDA’s assumption in one of the studies that overall survival data would not be available, noting that the study’s “implications 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.”

And Merck suggests that FDA consider limiting study recruitment to patients diagnosed with and/or treated for non-small cell lung cancer and patients diagnosed with and/or treated for multiple myeloma within the past two years, as well as caregivers and family members.

“Limiting the study participants to those in the cancer treatment milieu may allow for more targeted insights from a population of individuals who could reasonably be expected to have a high level of interest in gathering information about cancer treatments. Merck believes 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,” the company’s comment says.

United Healthcare, meanwhile, said it believed FDA’s research “will help answer critical questions regarding whether patients, health care providers, and caregivers understand information about the effectiveness of drug therapies and can make informed choices about treatment options.”  



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