Friday, May 9
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 the digital communications of their products. Sometimes the FDA’s line is bright and bold; other times it is fuzzy, leaving corporate communication’s executives making marketing decisions with crossed fingers. Clarity of 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, in which of the Office of Prescription Drug Promotion issued a total of 173 regulatory action letters. Results from the study provides valuable insight into the FDA current mindset and offers 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