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FDA Draft Guidance on Risk Communication
Reading the Tea Leaves

Tea leavesOn May 27, 2009, FDA published in the Federal Register draft "Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion."

This guidance focuses almost exclusively on print and broadcast promotional ads. It is possible, however, to apply some of FDA's "thinking" to certain kinds of Internet ads such as search engine paid ads.

This article reviews the draft guidance with a special focus on how it may apply to the Internet and how marketers can use the comment period to raise the issue of FDA regulation of sponsored search engine ads.

NOTE: Just for fun, try "Harry's Drug Risk Parlor Game" to gauge how risky you think Rx drugs are.

Topic headings include:
  • FDA Neglects the Internet in Its Studies
  • Omission of Risk Information
  • The Reasonable Consumer Standard
  • Summary of Draft Guidance
  • The Case of Adwords
  • FDA Study on Improving Presentation of Brief Summary

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PMN86-03
Issue: Vol. 8, No. 6: June/July 2009
Word Count: 3494

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Vol 8, #6 Contents







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