FDA to Study Impact of Efficacy Information in DTC Ads

In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug.

For the two-part study announced Monday, the FDA’s Office of Prescription Drug Promotion will survey diabetics using nine different mock print ads with differing levels of efficacy information, to see how the amount of information impacts decision making.

Each patient will be randomly assigned one of the nine versions of the ad, which will include market claims — such as the number one prescribed drug, or a new drug — and either high, low or no efficacy information. The ads will be differentiated as follows:

Efficacy Level Information:
"#1 Prescribed"
"New"
None (Control)
High
A
B
C
Low
D
E
F
None (control)
G
H
I

After viewing the ads, researchers will test respondents on their understanding — and perceptions about — the product’s risks and benefits, market claims, product quality and product acceptance by doctors. OPDP will also look at whether participants sought more information about the product and whether they believed the product claims made by the sponsor.

Afterward, the researchers will follow-up with participants to determine the trade off between efficacy level information and market claims.

The study is the latest in a string of DTC ad studies over the past year. The FDA also is investigating how hearing and aging affect TV ad comprehension, how spouses influence their partners’ perception of ads, how frequency of exposure affects perception of risks and benefits and how distractions such as moving visuals affect retention of information (DID, May 29, 2014).

View the Federal Register notice at www.fdanews.com/07-21-15-DTCAds.pdf.
— Kellen Owings

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