FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

Regulatory NewsRegulatory News | 20 July 2015 |  By 

Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making?

These are questions the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) intends to answer through a two-part study just announced in the Federal Register.


In addition to reviewing drug ads and promotional labeling "to ensure that the information … is not false or misleading," OPDP conducts research on direct-to-consumer (DTC) and professional promotional prescription drug materials.

In recent years OPDP has substantially increased its research operations. Since 2011, the office has completed 11 studies on various aspects of advertising and promotion and has five other studies awaiting peer review and publication.

These studies have ranged from examinations of side effect disclaimers to eye-tracking studies during television ads.

Market Claims and Efficacy

When considering advertisements, FDA breaks information into two categories: intrinsic and extrinsic. Intrinsic "cues" describe "physical characteristics of the product," such as size, shape or color. Extrinsic "cues" include non-physical information related to the product, such as price and brand name.

According to OPDP, "both intrinsic and extrinsic cues can influence perceptions of product quality [and] consumers may rely on product cues in the absence of explicit quality information." Some of these claims, such as "#1 prescribed" or "doctor recommended" may influence consumers in their decision-making process and "affect consumer beliefs about product efficacy."

ODPD also suggests that "providing consumers with efficacy information about generally improves understanding and improves decision making."

To determine how efficacy information impacts patient decision making, OPDP will be surveying patients with diabetes using nine different mock print ads with varying levels of efficacy information.

Efficacy Level Information:

 "#1 Prescribed"


 None (Control)









None (control)





Researchers will then test respondents to "investigate memory, perception, and understanding of product risks and benefits; perception and understanding of the market claims; perception of product quality; perceptions of the product acceptance by doctor, intention to seek more information about the product; and perceptions of trust/skepticism regarding product claims and the sponsor."

Afterward, the researchers will follow up with respondents to "examine the tradeoff between efficacy level and market share claim.”


Federal Register


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