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

Pharmaceutical companies and their agencies are "mulling" over amongst themselves how the drug industry should engage consumers and physicians via social media without violating FDA regulations. They are struggling because the FDA has never issued clear guidelines for how it may regulate the industry use of social media in the future. Many have called upon the FDA to issue such guidelines. Shouldn't we make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders? This article will present a review of this issue based upon input received from experts and respondents to the "Should FDA Convene a Public Hearing on Use of Social Media by Pharma?" survey hosted by Pharma Marketing News starting on April 2, 2009. Also included in a review of an ePharma Pioneer Club roundtable discussion on what it's going to take to enable pharmaceutical marketers to engage in social networks without fear of adverse event reporting and other regulatory, corporate, and cultural roadblocks. 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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PMN84-01
Issue: Vol. 8, No. 4: April 2009
Word Count: 4521

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• eMarketing and ePromotion
• Regulatory Compliance
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