FDA Studies Foreshadow Potential Changes to Direct-to-Consumer Prescription Drug Advertising
Tuesday, May 30, 2023
Direct to Consumer Prescription Oncology Drug Advertising

The Food and Drug Administration (FDA) recently conducted two online studies concerning comprehension of direct-to-consumer (DTC) prescription oncology drug advertising.  The research suggests that consumers may have difficulty understanding the consequences of various drug study endpoints, resulting in consumers’ overly optimistic views of study results and oncology drug efficacy. (Patient Understanding of Oncology Clinical Trial Endpoints in Direct-to-Consumer Television Advertising - PubMed (nih.gov).)  Two potential implications of the studies include:  (1) The FDA, which previously concluded in 2020 that research on this topic is needed, is likely to continue testing whether consumers sufficiently comprehend efficacy and risk profiles of drugs in DTC marketing in a variety of settings; and (2) the results of these types of research studies may make their way into FDA rulemaking, requiring pharmaceutical manufacturers to provide more explicit risk and dampened benefit disclosures in DTC advertising.

The FDA studies at issue involved whether consumers understood endpoints presented in two DTC television advertisements for fictitious oncology drugs, and whether comprehension improved with more explicit disclosure language in the ads.  For oncology studies, while overall survival improvement is the gold standard primary endpoint, for a variety of reasons, oncology studies often include other endpoints instead, such as overall rate response and progression-free survival, which do not necessarily mean that the patients taking the drugs lived longer.  Yet, consumers presented with these endpoints in the television ads often erroneously concluded that the drug had a survival benefit, regardless of the endpoint data presented.  When consumers were shown disclosure language that the study endpoint did not demonstrate a survival benefit, however, they were up to three times as likely to correctly conclude that the drug’s effect on overall survival is currently unknown.  The results of the FDA studies align with previous agency research about the role of clear disclosures in DTC advertising and further suggest that without sufficient disclosures, a high number of consumers draw inaccurate and overly optimistic inferences from the ads. 

The FDA’s research about consumer understanding of inferences that can be drawn from study endpoint data is developing, and the early results of this research point in the potential direction of additional disclosures in DTC advertising.  The key for pharmaceutical companies will be to continue to work with the FDA to best frame further agency research and potential disclosures while cognizant of the FDA’s growing view that disclosures should be explicit so that consumers are more likely to correctly understand the positive and negative limits of study data.  Pharmaceutical companies have the opportunity to submit public comments to proposed research projects of the FDA’s Office of Prescription Drug Promotion (OPDP).  Such opportunities are published in the Federal Register at the time of agency proposal.  Completed OPDP research studies can be found here.

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