Social Thoughts from RAPS 2010, Part II

Author: Elsa Abruzzo

As many of you may know in November 2009, FDA conducted an open Public Hearing to solicit public comments on promotion of FDA–regulated products using internet and social media tools.  The comment period to the Docket closed on February 28, 2010 and FDA expressed that having a guidance by the end of 2010 is a priority.  Glenn Byrd suggests we ask ourselves a couple of questions in the interim –   “What is our risk tolerance?” and “What do we want to achieve with internet and/or social media tools?”  With respect to the latter, are we looking for brand, disease or corporate focused communications?   Byrd also urges industry to listen to their various audiences and apply exiting regulations and guidance.  He specifically lists some oldie-but-goody pearls of regulatory wisdom:

  • Content cannot be false or misleading and must provide a balanced presentation of risk/benefit and must present all material facts.
  • Disease information cannot incorporate design or content elements that create perceptual similarities to products.
  • the FDA established a Social Media Working Group, comprised of staff from DDMAC, APLB, and CDRH.

His practical advice to us is similar to what our blog has been preaching along: you need a system to deal with social media, as you do with conventional promotional materials, and you need to communicate often with your internal teams (marketing, sales, legal, and quality).  In fact, maybe we need to go back to the fundamentals and review the PACE process, Promotional Review Committees (PRCs), etc.  Until next time, keep vigilant.

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Related Links:

Social Thoughts from RAPS 2010, Part I

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