Drug and Device Info on the Internet

On November 12 and 13 the US Food and Drug Administration (FDA) held a "Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." If you would like to view a video of the public meeting on this topic, you may do so at the following link: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm.

Tony Blank of Boston Scientific speaks on behalf of AdvaMed in the first morning session of the first day. Jeffrey Francer speaks on behalf of PhRMA during this same session. In addition, representatives from Eli Lilly, sanofi-aventis, Johnson and Johnson and Pifzer also give short presentations on behalf of manufacturers.

Comments on the hearing are due by February 28, 2010.

Some of the issues that arise seem to be: 1.) how to distinguish between reliable FDA- approved information and unreliable information on the web, 2.) what should, if anything, a manufacturer do if someone posts inaccurate information about their product on the internet; should they police this and respond?; if so, are they assuming responsibility for all the content of the blog that they are responding to? and 3.) what are the responsibilities of a manufacturer if they post reliable information and a third-party modifies it. Some problems that I have experienced: What do you do when study patients or clinical investigators communicate on a blog and mention potential adverse events that have not been reported on the study case report forms? Should someone at the sponsor be monitoring these blogs?

Steve