Having held the Super Bowl of Part 15 hearings on social media, the big question is, what’s the FDA’s next move?
After the FDA docket closes in February, DDMAC will review all the materials—and there will be a lot of material to be reviewed by a pretty spare staff. Only then will the FDA decide what—if anything—it wants to do. So, what will we see and when will we see it?
My prediction—a guidance sometime in late 2010 or early 2011 that focuses on three issues: The range of adverse event reporting responsibility (and a definition of what “sponsored” means); ways to make MedWatch more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and online); and the creation of “safe harbor” parameters to allow regulated industry to correct misinformation on the Internet.
I believe the FDA should create a social media adverse event Facebook page that people can “friend” in order to learn more about how to report “official” adverse events and through which the agency can push out important safety alerts and other important risk information. After all, MedWatch only captures about 10% of all adverse events.
FDA operates in FDA time (“the time it takes to get it right”)—almost the opposite of social media time, i.e., immediate gratification. And as Aaron Burr said: “Never do today what you can put off until tomorrow. Delay may give clearer light as to what is best to be done.”
Better for the FDA to heed the words of Benjamin Franklin: “You may delay, but time will not.”
Peter J. Pitts is partner/director of global health at Porter Novelli and a former FDA associate commissioner
From the January 04, 2010 Issue of MM+M - Medical Marketing and Media
