Thursday, November 08, 2012

Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:
"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."
I have three comments regarding this:
  1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."

  2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").

  3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").
So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

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