Remember five or so years ago when we put together a campus event about the FDA call for input on social media guidance? I blogged about it a lot. I’m sure many of you are already aware of the new FDA Social Media draft guidelines that were, at long last, released last month.
Recently I heard an interview with David Harlow about the new draft guidelines. I was very surprised when I heard him say that the FDA sent a warning letter to a company for clicking “like” on a patient’s Facebook post. That seemed a bit over the top to me, although I confess I haven’t yet found the original warning letter. I had been inclined to just trust that after thinking about this so long, the FDA would come out with something helpful, but it sounds like that isn’t what happened. Responses from the drug companies seem to be along the lines of just avoiding the whole problem, if the FDA is going to be so challenging and confrontational. Responses from folk working actively in HCSM are that the FDA is not getting the point or purpose of social media engagement, and that the guidelines are sufficiently restrictive as to make it impossible to adhere to the specifications.
I know that I need to know more about this, and I believe that readers of this blog do also. The period for public comment is over in September, so there is very little time to respond. My fault — I should have paid closer attention to this sooner.
For context, I’d like to first remind people of the comments we filed with the FDA during the original call for comments. Where it sounds like things have broken down is with respect to our third point (#3): “the potential to be perceived as interfering with free speech of the public or creating an undue and insupportable burden for industry and the healthcare communities,” and to the concerns about use of social media within an educational framework.
FDA-2009-N-0441 Docket Comments, University of Michigan Public Forum: http://www.slideshare.net/umhealthscienceslibraries/fda2009n0441-docket-comments-university-of-michigan-public-forum
Here are my slides from five years ago, just to provide context for the background of the conversation.
FDA Social Media Guidelines – Introduction http://www.slideshare.net/umhealthscienceslibraries/fda-social-media-guidelines-introduction
Now, here are some links about where things stand today, plus the presentation by David Harlow, which I encourage you to watch.
FDA Social Media Changes that May Affect Healthcare https://www.youtube.com/watch?v=aEutmz0kFsM
#FDAsm – FDA Releases Draft Social Media Guidance Five Years After Public Hearing http://www.healthblawg.com/2014/06/fdasm-fda-releases-draft-social-media-guidance-five-years-after-public-hearing.html
FDA Social Media Guidance – Hangout on Air http://www.healthblawg.com/2014/07/fda-social-media-guidance-hangout-on-air.html
2009: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm
July 10, 2014: Social Media Guidance Webinar – July 10, 2014: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm403810.htm
FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-issues-draft-guidances-for-industry-on-social-media-and-internet-communications-about-medical-products-designed-with-patients-in-mind/
Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability http://www.gpo.gov/fdsys/pkg/FR-2014-06-18/html/2014-14221.htm
NOTE: This is where to file comments >>
[Docket No. FDA-2014-D-0447] Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability https://www.federalregister.gov/articles/2014/06/18/2014-14221/draft-guidance-for-industry-on-internetsocial-media-platforms-correcting-independent-third-party
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf
Guidance for Industry : Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Jan 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf