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.
