The FDA has been authorized to conduct a study attempting to assess concerns that, on the one hand, the current length of the major statement is too long for patients to absorb and that, on the other hand, current advertisements exclude risks that are important to patient decision-making.
As described in the Federal Register, there are currently “conflicting viewpoints” regarding the effectiveness of the required disclosure of risk information in direct-to-consumer broadcast drug advertisements.
Accordingly, the FDA will examine the hypothesis that, “relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks.”
The study design, which will modify existing drug ads to be shown to study participants, was met with mixed reviews by Industry during the comment period. Although PhRMA raised concerns in its comment that this design could lead to confusion where participants have already viewed the unmodified ads outside of the study, the FDA has elected to “balance the integrity of the research with cost considerations” by including survey questions to control for ad familiarity. The FDA has added questions to the survey in response to AbbVie’s comment, which suggested a question about how actionable the risk information is, and Pfizer’s comment, which included a recommendation to assess clarity of the major statement and whether or not participants believe the right amount of risk information was presented.
Turning the conversation to an issue of regulatory authority, the Washington Legal Foundation questioned the FDA’s standing to require a major statement at all. Its comment proposed that the study be expanded to yield data necessary to perform a First Amendment analysis of the condition that risk information be presented alongside benefit claims. The FDA declined to expand the scope of the study and added in a footnote, “We also note that we disagree with several aspects of the comment’s assertions related to First Amendment law, but we do not believe it is necessary or appropriate to address those arguments here.”