FDA is planning four separate studies of how Internet advertising by drug companies affects consumer understanding of prescription drug safety and efficacy through such aspects as text formatting, patient testimonials and links to outside organizations.

Three of the studies will be "experimental" and the fourth will be "qualitative," according to the announcement slated to appear in the April 28 Federal Register. The agency provided no information on the qualitative study beyond the bare mention of it, however.

The announcement also does not mention that the Division of Drug Marketing, Advertising and Communications will be conducting the studies, although they clearly seem to be part of a series of studies DDMAC has been running and were first announced last year (Also see "Census Delays Planned DDMAC Studies On Various Aspects Of DTC Advertising" - Pink Sheet, 26 April, 2010.).

FDA Putting Firms In A Scroll Lock?

The first study, which will enroll 4,000 participants to examine the format and visibility of risk information on the homepage of prescription drug websites, may use fictitious drugs that treat high cholesterol and seasonal allergies, the agency says.

The point of this study is to examine the possible impact on patient understanding of whether the risk information is presented in a paragraph or as a bulleted list and whether it can be seen without scrolling down or not.

Those formatting questions may be particularly tricky to devise a clear answer to, especially given the variety of screen sizes and devices that people now use to access the Internet (Also see "DTC Smartphone Ads Present An “Interesting” Problem For DDMAC" - Pink Sheet, 18 October, 2010.).

The consideration of these formatting details also highlights the double-edged sword that any eventual guidance on FDA might be for industry. Advertisers badly want to know what they can and can't do online, and they've felt stung by the agency's repeated failures to meet its own announced deadlines for issuing guidance. But as much as they'd want to know, firms would rather not have FDA dictate the entire structure of their websites to them.

The second study, which will enroll 2,000 participants to look at the impact of personal testimonial videos and interactive visuals, may use fictitious drugs for depression and acid reflux disease, while the third study, looking at the impact of external links, may involve a fictitious high blood pressure medication.

Personal testimonial videos are an area of special concern for DDMAC and have triggered enforcement letters to manufacturers who abuse them, such as the patient testimonial videos on the homepage of Wyeth's Premarin (conjugated estrogens tablets), which drew the company a notice of violation letter on April 12, 2010, because there were no risks mentioned in the audio/visual presentations (Also see "FDA's Internet Promotion Policy: Christmas Cards In Lieu Of Guidance?" - Pink Sheet, 3 January, 2011.).

In the link study, FDA will examine the impact of hyperlinks to an external organization's website, citations from external organizations and what difference the type of organization makes (such as nonprofits and online health communities), enrolling 3,600 participants for this purpose.

In all three studies, which will run concurrently, the participants will be randomly assigned to view the different types of ads of interest, in factorial designs. FDA expects the interviews in all three studies to last no more than 25 minutes.

Control groups will be used in the link and video studies, but not in the formatting study. An additional 1,200 participants will be enrolled in "pretests."

-Martin Berman-Gorvine (m.berman-gorvine@elsevier.com)

FDA Advertising Studies Will Examine Website Formatting, Patient Testimonials, Outside Links

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