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Ramifications of FDA Regulatory Actions
Helping FDA Find a New Media Regulatory Pathway

New FDA PathwayOn April 2, 2009, the FDA issued 14 letters informing drug companies that their search engine ads, which included drug brand names and indications but no risk information or fair balance, were in violation of the law. This caught many in the drug industry by surprise because they assumed the "one-click rule" applies; ie, as long as the fair balance information was just one click away -- on another Web page -- such ads are allowed by the FDA. With the 14 letters, FDA disagreed and quashed the "one-click rule."

Arnold Friede, counsel to the law firm McDermott Will & Emery LLP, and former Senior Counsel at Pfizer, believes that there is an opportunity now to make a strong and compelling argument for the adoption of rational regulatory policies by the FDA that address the unique features not only of sponsored links, but of other kinds of new communication tools, such as social media and the like.

This article reviews legal ramifications of FDA enforcement letters and focuses on the FDA's contentious regulation of Internet advertising and what the industry is doing to "help" it find a new path in that arena. Included is a discussion of FDA's draft guidance "Presenting Risk Information in Prescription Drug and Medical Device Promotion" and the relevance of FDA's/FTC's "reasonable consumer standard" to search engine paid promotional drug ads.

Topic headings include:
  • Making a Case for New Regulations
  • Ramifications of Enforcement Letters
  • Effect on Company Valuation
  • Advertising May Go Dark
  • Profits Could be Affected
  • Every Letter Has Another Life in Court
  • Organizing the Response
  • Cheerios vs. the One-Click Rule: Are FDA's Priorities "Askew?"
  • Reaching Consensus
  • An Alternative Framework
  • The Reasonable Man Standard
  • Junk Hides the Gems
  • Real Problem is Lack of New Media Guidance

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PMN85-02
Issue: Vol. 8, No. 5: May 2009
Word Count: 3653

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Vol 8, #5 Contents








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