Developing Guidelines for Pharma’s Use of the Internet & Social Media Whatever! A Call for a Public Hearing at FDA

Clear GuidancePharmaceutical companies and their agencies are “mulling” over amongstthemselves how the drug industry should engage consumers and physiciansvia social media without violating FDA regulations. They are strugglingbecause the FDA has never issued clear guidelines for how it mayregulate the industry use of social media in the future. Many havecalled upon the FDA to issue such guidelines.

Shouldn’t we makesure that when it comes time for the FDA to actually create a guidancedocument on social media that it does it with input from ALLstakeholders?

This article will present a review of this issuebased upon input received from experts and respondents to the “ShouldFDA Convene a Public Hearing on Use of Social Media by Pharma?” surveyhosted by Pharma Marketing Newsstarting on April 2, 2009. Also included in a review of an ePharmaPioneer Club roundtable discussion on what it’s going to take to enablepharmaceutical marketers to engage in social networks without fear ofadverse event reporting and other regulatory, corporate, and culturalroadblocks.

Topic headings include:

  • The 14 Letters were No April Fools’ Joke!
  • An Unmet Need for Regulatory Guidance
  • FDA, Tear Down This Wall!
  • Call for Public Hearing
  • Lessons Learned from the “One-Click Rule”
  • Lack of Knowledge is No Excuse
  • There is a Precedent
  • A Clear Path Needed
  • Survey Results
  • A Moving Target
  • The Views of Skeptics
  • What Good Can Come from a Public FDA Hearing on Social Media?
  • Alternatives to a Public Hearing

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Issue: Vol. 8, No. 4: April 2009
Word Count: 4521

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