Life Science Compliance Update

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July 11, 2016

Industry Expresses Concerns About FDA DTC Study

AbbVie, Eli Lilly, and Merck are all raising questions about the Food and Drug Administration's (FDA) plan to investigate the impact on consumer perceptions of prescription drugs when efficacy claims are included in advertisements. The Office of Prescription Drug Promotion (OPDP) conducted a study of direct-to-consumer (DTC) print advertising of drugs in 2015. OPDP plans to continue grappling with a better understanding of how consumers make choices and whether or not they really focus on efficacy claims or not.

The study, along with several others, follows the introduction of a bill by Representative Rosa DeLauro that would place a three-year moratorium on DTC ads of newly approved prescription drugs to fight rising drug prices and protect consumers from misleading information.


Prior research has found that marketing cues can have an influence on perceptions of drug quality and that patients and consumers may rely on those cues in the absence of quality information.

According to the FDA,

The objective quality of prescription drugs is not easily obtained from promotional claims in direct-to-consumer (DTC) ads; thus consumers may rely upon extrinsic cues to inform their decisions. Market claims such as '#1 Prescribed' and 'New' may act as extrinsic cues about the product's quality, independent of the product's intrinsic characteristics. Prior research has found that market leadership claims can affect consumer beliefs about product efficacy, as well as their beliefs about doctors' judgments about product efficacy.

FDA Study Plans

OPDP will run a main study, along with a follow-up, that will analyze consumer responses to fictitious prescription drug ads for a diabetic neuropathy treatment. There are two variables of interest to OPDP: the type of market claim (i.e., "#1 Prescribed," "New," etc.) FDA notes that the efficacy information will be in the form of realistic quantitative information (think, "46 percent of patients felt their nerve pain reduced by at least half, compared to baseline").

In the follow-up study, participants will complete a fifteen-minute paired choice experiment and will be asked to choose between two hypothetical drugs based on print advertisements, one of which includes a market claim from the Main Study. Participants will be provided with 48 sets of choices, with varying levels of efficacy information and market claims, and will be asked which drug they prefer based on them.

Industry Reaction and Comments

AbbVie raised concerns with questions in the study being biased by attitudes toward advertising in general that "may go well beyond the pharmaceutical ad" and that ads that present numeric efficacy claims and safety information may be susceptible to interpretation by participants.

Eli Lilly, on the other hand, has concerns with one of the research objectives for the main study, believing that it "suggests that the study will measure perceptions of the doctors' acceptance of the drug by respondents. Since respondents will only be seeing a print ad and not interacting with a doctor, we believe the research setting will be too artificial to gain meaningful insights into this topic."

Merck takes issue with several aspects of the study and would like for the FDA to "focus their efforts and research first on improving the health literacy of approved patient labeling and then on DTC print advertising. In addition, FDA should consider exploring the inclusion of benefit information in patient labeling, which may help improve consumer understanding and comprehension of patient labeling." Merck further suggests that for the follow-up study, the FDA reduce the number of trials for respondents across health literacy levels, as respondent fatigue can occur. Respondent fatigue is concerning because it can result in a reduced focus and unreliable responses.

The FDA somewhat responded to these concerns, noting that prior research has shown that consumers can actually reach numeric judgments about efficacy and risk despite the fact that no numeric information has been presented in an ad and that the FDA worked with an expert reviewer at OPDP to "produce efficacy claims that are realistic for this drug class."

The FDA agreed with Merck's concerns about the follow-up study and respondent fatigue, noting that pretest data "may reveal that the experiment can be shortened without loss to validity."

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