After years of waiting, the FDA has finally released a little guidance to help Pharma companies navigate the social media waters. Late last week, it released "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices". In this fifteen page piece, the FDA addresses how Pharma companies should address those online looking for information on drugs for reasons other than why the drug would be prescribed.
In the article from AdAge, FDA spokeswoman Karen Mahoney stated, "We understand the level of interest and wanted to get out what we had available to provide guidance, the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009."
Read the social media guidance here. At the 2012 ePharma Summit, the MLR Summit, you’ll analyze the specifics of off-label reporting and have an opportunity to discuss digital marketing from a regulatory perspective when industry experts discuss what matters most to them.
Was this what you expected from the FDA as their first guidance on social media? What do you think of it, and what do you expect to see next from the FDA?