On 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draft guidance with a special focus on how it may apply to the Internet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:
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- 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- Summary of Draft Guidance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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