Friday, May 9
10:30–11:45 a.m.
Breakout Sessions: Set IV

“Fair or Foul? Working Within the FDA’s Rules for Digital Communications”

Changing regulations, security issues and disclosure requirements have pharmaceutical and biotechnology companies walking a blurred line when it comes to federal regulations that guide their products' digital communication. Sometimes the FDA’s line is bright and bold; other times it is fuzzy, leaving corporate communications executives to make marketing decisions with crossed fingers. Clarity of the FDA’s product communication guidelines is urgently needed because of the increasing numbers of consumers, patients and health care providers who base their medical decision-making on health-related information online, and are engaged in relationships based in social media.
 
This presentation reviews the four-year period between 2008 and 2012, during which of the Office of Prescription Drug Promotion issued a total of 173 regulatory action letters. Results from the study provide valuable insights into the FDA's current mindset, and offer recommendations on how marketers and public relations professionals can stay on the safe side of the evolving regulations governing online communications.
  
Mark Senak, senior vice president and partner, FleishmanHillard; writer, Eye on FDA blog
 

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