FDA Draft Guidance on Risk Communication Reading the Tea Leaves

Tea leavesOn May 27, 2009, FDA published in the Federal Register draft “Guidancefor Industry, Presenting Risk Information in Prescription Drug andMedical Device Promotion.”

This guidance focuses almostexclusively on print and broadcast promotional ads. It is possible,however, to apply some of FDA’s “thinking” to certain kinds of Internetads such as search engine paid ads.

This article reviews thedraft guidance with a special focus on how it may apply to the Internetand how marketers can use the comment period to raise the issue of FDAregulation 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  • Summary of Draft Guidance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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Issue: Vol. 8, No. 6: June/July 2009
Word Count: 3494

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