3 Risk-Benefit Tips for DTC Websites from FDA Studies


Just recently, the FDA gave us a hint of how they are currently thinking about fair balance and risk information when using websites to advertise.

On April 28, 2011, the FDA proposed and requested comments on three studies to test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug websites.  While the comment period is now closed, here’s a summary:

Study 1 – Investigate whether the presentation of risk information influences consumers’ perceptions and understanding of risks and benefits by examining the format (e.g., a paragraph vs. bulleted list) and visibility (i.e., seen without scrolling down vs. requiring the user to scroll).

Study 2 – Investigate how special features (e.g., personal testimonial videos and interactive visuals) influence perceptions and understanding by looking at the prominence of the risk information (e.g., including the risks in the spoken testimonial vs. scrolling text at the end of the video).

Study 3 – Investigate whether links and citations to external organizations referenced on the homepage influence consumer perceptions and understanding by examining the type of link (e.g., hyperlink to an external organization’s website vs. a citation to the external organization) and the type of organization (e.g., non-profit vs. online health community).

What can you learn from the FDA’s proposed studies? While FDA so far is just studying these issues, you might consider three possible takeaways to add to your promotional review committee (PRC) procedures for DTC websites:

1. Format and visibility of risk information matters. 

  • Ensure that patients don’t have to scroll to see risk information. In marketing speak, it should be “above the fold.”
  • And, put risks in a bulleted list–not buried in an obscure paragraph a patient might skim.

2. Videos and interactive media are of particular concern.

  • Do away with risks rolling at the end of the video like unimportant credits. When do you leave the movie theatre? Do you always sit, watching intently through the credits?
  • Feature risks as a natural and important part of the information a patient wants to know to make an informed decision.

3. External links on DTC homepages are under scrutiny.

  • While you cannot control the content on external websites, ensure that you are featuring links to sites which offer accurate information with clear conflict-of-interest (COI) disclosures.
  • Also test the net impression of the external links for fair balance. Are they all very positive? If so, consider adding links which represent a wider cross-section of opinions.

Because the purpose of this effort is to support the agency’s development of guidance, the studies will use a controlled design with a fictitious website marketing a fictitious prescription drug.  The agency intends the participants to be consumers diagnosed with the high prevalence medical condition treated by the fictitious drug.  So don’t worry; your website is not part of the study…yet!

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