DTC Risk Disclosures Examined By FDA; Do Minor Risks Swamp Major Ones?

FDA will evaluate how the presence of minor safety risks in the brief summary of print direct-to-consumer advertisements impacts consumer comprehension of major risks.

The study is part of the agency's effort to finalize its guidance on the design of the brief summary statement included in print ads.

The brief summary requirement for print ads is typically fulfilled by reprinting the risk-related sections of labeling verbatim.

"While this is one reasonable way to fulfill the brief summary requirement for print advertisements directed toward health professionals, this method is difficult for consumers to understand and therefore may not be the best approach to communicate this important information to them," FDA states in a March 14 Federal Register ¹ notice soliciting comments on the study.

The study will compare placebo rate, which is the typical context in which adverse events are framed, with both the frequency and temporal nature of side effects.

"We will manipulate the minor side effect section, carrying the presence of frequency information and the presence of framing, and the efficacy section, varying the presence of frequency information," FDA states.

"We are interested in how these changes influence the understanding of the risks of the product as a whole, particularly the more serious risk sections," FDA states. "If these changes enhance or, at the very least, do not detract from the major risks, then these additions of context may be something to include in future brief summaries."

A study by AstraZeneca on DTC television advertising found that communication of more than five risks leads consumers to remember less severe risks (² (Also see "AstraZeneca Takes Five: DTC Study Finds Five Risks Per Ad Is Optimal For Recall" - Pink Sheet, 15 May, 2006.), p. 8).

FDA will also conduct a study to evaluate different brief summary formats that were proposed in the agency's draft guidance (³ (Also see "Risk Information “Window” Proposed By FDA For DTC Print Ads" - Pink Sheet, 9 Feb, 2004.), p. 4).

"In addition to the patient package insert, which is usually presented in a question and answer format, FDA proposes to test a consumer-friendly highlights format, as well as a format based on the drug facts labeling used for over-the-counter drugs."

Four different ads will be developed to test the traditional long format, Question and Answer format, Highlights format and Drug Facts format.

"Participants who self-identify as being in the target market for the condition will be asked to read a single print advertisement for a new prescription drug."

The agency is hoping to gain insight into which format consumers prefer and whether format differences will "influence comprehension of major risks, behavioral intentions, and/or self-efficacy."

FDA estimates that it will need to screen 600 people using a mall-intercept protocol to obtain 300 respondents for the format study and 1,800 people to obtain 900 respondents for the context study.

The agency is currently conducting a study to investigate consumer goals when reading DTC ads and the relative usefulness of the information presented (⁴ (Also see "FDA DTC Study Should Use Real Ads, Be More Conversational – AstraZeneca" - Pink Sheet, 2 May, 2005.), p. 14).

In previous comments on the study plans, AstraZeneca had suggested that FDA delay the format and context studies until data from the first study on consumer goals are collected, but the agency is proceeding.

"Study 1 is currently in the field and we expect to have data available by the midpoint of the year," FDA states in the notice. "These results will be analyzed in the next several months. Given the interest in the finalization of the brief summary guidance, which in part relies on information from these studies, we cannot delay the development of studies 2 and 3 until data from study 1 are analyzed and interpreted."

"Data from these two studies will converge to allow a better assessment of various ways to present risk information in a print advertisement for a prescription drug," the agency said.

- Brian Marson ([email protected])