While a few individuals and agencies have submitted comments to the FDA regarding regulation of pharma marketing on the Internet, to date only one adhoc group of pharmaceutical industry representatives have submitted comments. That group is the the Social Media Working Group (SMWG), which has come together to "facilitate discussions with the Division of Drug Marketing, Advertising and Communications, industry associations, and other pharmaceutical manufacturers on social media issues. The SMWG includes representatives from the following companies: Amgen, Inc.; AstraZeneca LP; Bristol-Myers Squibb; Millennium Pharmaceuticals, Inc.; and sanofi-aventis U.S."
This article reviews the Who, What, and Why of this group based on a conversation with Mark Gaydos, Senior Director, U.S. Regulatory Affairs Marketed Products at sanofi-aventis, and Cynthia Phillips, Sr Dir Labeling and Promotional Compliance at Millennium Pharmaceuticals. Also covered is an analysis of comments the SMWG submitted to the FDA on how pharmaceutical companies should handle off-label and adverse event posts made on social media sites owned or sponsored by them.
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