Regulatory Focus™ > News Articles > Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

Posted 04 May 2016 | By Zachary Brennan 

Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements.

The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015, will also seek to better understand if consumers make different choices based on these efficacy claims.

The study, and others on other forms of pharma advertising, comes as Rosa DeLauro (D-CT) in February introduced a bill 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.

Background

According to FDA, prior research has found that marketing cues can influence perceptions of drug quality, and consumers may rely on such cues in the absence of quality information.

“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,” the agency says.

However, previous studies were limited by a lack of quantitative information about product efficacy, and research indicates that providing consumers with such efficacy information “generally improves understanding” of the drug and “may moderate the effect of the extrinsic cue by providing insight into characteristics that would otherwise be unknown.”

FDA Study Plans

Taking the prior research into account, OPDP is planning to run a main study and a follow-up that will analyze consumer responses to fictitious prescription drug ads for a diabetic neuropathy treatment. Two variables will be of interest for OPDP: type of market claim (ie. #1 Prescribed, New) and type of efficacy information (ie. High, Low, or None).

FDA says the efficacy information will be in the form of realistic quantitative information (for example, “46 percent of patients felt their nerve pain reduced by at least half, compared to baseline”).

In the follow-up study, participants (n = 216) will complete a 15-minute paired choice experiment and will be asked to choose between two hypothetical drugs based on print ads, one of which includes a market claim from the Main Study (#1 Prescribed or New).

The ads also include different efficacy information (for example, “46 percent of patients felt their nerve pain reduced by at least half, compared to baseline” versus “51 percent of patients felt their nerve pain reduced by at least half, compared to baseline”).

Participants will be given 48 sets of choices, with varying levels of efficacy information and market claims, and will be asked which drug they prefer.

Industry Comments

In comments released Wednesday, AbbVie, Eli Lilly and Merck (as well as two anonymous commenters and a pharmacist who called to ban DTC ads, which FDA says is outside the scope of this project) weighed in on the prospective study.

Abbvie took particular concern with questions from the study being biased by attitudes toward advertising in general that “may go well beyond the pharmaceutical ad” and that ads presenting numeric efficacy claims and safety information can be open to interpretation by the participants.

FDA, in response to these comments, notes that prior research has shown that consumers can reach numeric judgments about efficacy and risk despite no numeric information being presented in an ad, and the agency has worked with an expert reviewer in OPDP “to produce efficacy claims that are realistic for this drug product class.”

Lilly, meanwhile, takes issue with one of the research objectives for the main study, which it says “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.”

FDA, in response, says it’s “endeavoring to replicate the results of Mitra et al. (Ref. 4), who found that market leadership claims affected consumer beliefs about doctor's judgments.”

Merck also takes issue with several aspects of the study and says FDA “should 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.”

For the follow-up study, Merck also recommended reducing the number of trials for respondents across health literacy levels, as respondent fatigue can occur, resulting in reduced focus and unreliable responses, which FDA said it agreed with, noting that pretest data “may reveal that the experiment can be shortened without loss to validity.”

Federal Register on Market Claims in Direct-to-Consumer Prescription Drug Print Ads

 


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