FDA to probe website DTC risk/benefit

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The FDA announced plans to study online consumer advertising for prescription drugs in order to resolve “a number of questions surrounding how to achieve ‘fair balance' in online DTC promotion.”
The three studies, announced in today's Federal Register, will “test different ways of presenting prescription drug risk and benefit information on branded drug Web sites” and will “complement qualitative research we plan to conduct on issues surrounding social media.”
The agency plans three concurrent experimental studies, to be followed by a qualitative study:
  • The first study, with 4,000 participants, will look at the format – for example, whether the risk info is presented in a paragraph or as a bulleted list – and visibility (whether risk info can be seen without scrolling down) of risk info on Brand.com homepages.
  • The second study, of 2,000, will look at how features like personal testimonial videos and interactive mechanism of action visuals on Brand.com sites influence understanding of risks and benefits. “We will examine these special features in the context of the prominence of the presentation of risk information in two levels, more prominent and less prominent.”
  • The third study, of 3,600, will look at whether links to and citations from external organizations, such as the American Heart Association, referenced on Brand.com homepages influence risk/benefit perceptions.
As in past FDA studies, participants will view versions of a website for a fake drug. Participants will be consumers that have been diagnosed with a medical condition relevant to the drug. The agency said past studies looking at how DTC websites communicate risks and benefits have found that risk information is often presented less prominently and in fewer locations on websites, and that risk info on the web is often incomplete and written in medicalese or other language inaccessible to laymen.
The study suggests a further delay in the agency's promised guidance on social media and internet marketing of prescription drugs, which the Federal Register notice alluded to. “This research is relevant to current policy questions and debate and  will complement qualitative research we plan to conduct on issues surrounding social media,” the agency said, noting that its current rules didn't anticipate the internet. “This dynamic is shifting, and evidence is needed to support guidance development.”
A 60-day public comment period on the study closes in June.
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