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Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had

It’s almost been almost a week since the FDA hearings on social media wrapped up. If you missed it, then you missed a bit of history. Well, you sort of missed a bit of history. It’s not the fall of the Berlin Wall or anything, but it’s pretty rare that the FDA has a hearing like this. I’m not going to begin to try to give you all the links you need to review what happened and instead I’m going to point you to the source for the latest and greatest on all things FDA social media, the #FDASM site created by Fabio Gratton. That’s where you can get links to all the presentations, the Twitter feed of the #FDASM hashtag, downloadable copies of many of the presentations, and a lot more.

Okay, so my take…

As you know, I did have the privilege of speaking twice at this meeting (you can get copies of my presentations here), but I also got to listen to the 60+ other speakers. I had some preconceptions of what I’d hear at the meeting and many of these were right on, but I also was surprised by a few things and learned a few more. At the same time, I didn’t hear the answers to a few things that have been nagging me.

Today I’m speaking at a Business Development Institute conference about my experience. My talk title is: “Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had.”

Not the shortest title I’ve ever used, but it’s descriptive.

I won’t recap the entire presentation here, but see below for a link to download my presentation, which includes my speaking notes and see for yourself. For those of you who were/are at the conference today, thanks for stopping by.

In summary, here are the three things I learned:

  • The FDA gets it
  • MedWatch is dead (a serious AE, BTW)
  • Consumers might actually want us there

And, the things I didn’t learn (but wish I had):

  • FDA’s plan for keeping up
  • The end of red herrings
  • What pharma REALLY wants to do

As usual, my topic headlines don’t make much sense on there own, so I’d invite you to download a copy of my presentation and read along with the speaker’s notes for more detail. I’ll be writing about a few of these topics in future posts, so more detail will be forthcoming. In the meantime, for my initial thoughts on the FDA hearings, feel free to download a copy of my POWERPoint here:

Three Things I Learned at the FDA Social Media Hearings and Three I Wish I Had (1326 downloads)

I presented this at a recent BDI conference. I recorded my talk and matched it up to the slides via the magic at SlideShare. You can check it out below. Press the green play button to hear the audio. The slides will advance on their own or you can just click through at your leisure.

FDA Social Media Review From Dose Of Digital

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About The Author


Jonathan Richman

Jonathan Richman

Jonathan is the creator of Dose of Digital. You can find him on Twitter and here's his official Google+ profile.


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  • http://www.willvideoforfood.com/ nalts

    I’m so glad you’re at the top of my RSS… this sent me into a 2-hour self-serve education session. I suppose what I’m most excited about is the prospects of that space city for the next hearing. I intend to fly my space car to the next hearings with the brains of John Mack and Bruce Grant in a jar in my trunk.
    .-= nalts´s last blog ..Brightcove for $99 per Month. What’s This Mean to a Crowded Platform Space? =-.

  • http://www.willvideoforfood.com nalts

    I’m so glad you’re at the top of my RSS… this sent me into a 2-hour self-serve education session. I suppose what I’m most excited about is the prospects of that space city for the next hearing. I intend to fly my space car to the next hearings with the brains of John Mack and Bruce Grant in a jar in my trunk.
    .-= nalts´s last blog ..Brightcove for $99 per Month. What’s This Mean to a Crowded Platform Space? =-.

  • http://brassandivory.blogspot.com/ Lisa Emrich

    Jonathan, I’m not so sure I agree that MedWatch is dead. It certainly isn’t well-advertised nor well-known, but it does offer a good service to the consumer. After listening to the FDA hearings, I took a long tour of the MedWatch pages.

    I summarized what seem to be the most relevant bits of information for my fellow patient readers http://bit.ly/35TVnH . It’s true that the information is not streamlined and I did found variations of the same theme on different pages. However, it was fairly consistent throughout.

    I suspect that folks who discussed MedWatch during the hearings saw this page http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm which says that there are TWO ways to report adverse events to the FDA.

    However, look at the sidebar on the left. There is a link to the online submission form found on this page https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm . I located a link to the same page within a separate piece of pharma communication using this url – https://www.accessdata.fda.gov/scripts/medwatch/ .

    The online option has apparently been available for some time. But again, that is not commonly known. And FDA even offers a widget which can be placed on websites and blogs, see http://www.fda.gov/Safety/MedWatch/ucm128254.htm (page last updated 6/19/2009).

    So perhaps you can help me spread the word link to my post at HealthCentral which provides information which should be understandable to the average patient. http://www.healthcentral.com/multiple-sclerosis/c/19065/95209/adverse

    Thanks,
    @LisaEmrich

    BTW, I have enjoyed following the discussion surrounding pharma/social media.
    .-= Lisa Emrich´s last blog ..Patients for a Moment at ChronicBabe =-.

    • http://www.doseofdigital.com/ Jonathan Richman

      Thanks, Lisa.

      Perhaps “MedWatch is dead” was a bit of an overstatement (a bit of poetic license I suppose), however, I do believe that in its current format it isn’t valuable to consumers nor is it likely to entice them to actually submit adverse events. It needs some fundamental changes to ensure that patients feel like they get some value out of going through the trouble to fill out a form or call someone on the phone. Either way, it’s 15-30 minutes out of their lives and for what? What’s in it for them? Until FDA can answer this question, it will never be as effective as it could be in collecting adverse events. So, perhaps “MedWatch is dead” was an overstatement, but I wish the current format WAS dead and replaced with something that consumers are far more likely to use, which in the end, will benefit everyone.

  • http://brassandivory.blogspot.com Lisa Emrich

    Jonathan, I’m not so sure I agree that MedWatch is dead. It certainly isn’t well-advertised nor well-known, but it does offer a good service to the consumer. After listening to the FDA hearings, I took a long tour of the MedWatch pages.

    I summarized what seem to be the most relevant bits of information for my fellow patient readers http://bit.ly/35TVnH . It’s true that the information is not streamlined and I did found variations of the same theme on different pages. However, it was fairly consistent throughout.

    I suspect that folks who discussed MedWatch during the hearings saw this page http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm which says that there are TWO ways to report adverse events to the FDA.

    However, look at the sidebar on the left. There is a link to the online submission form found on this page https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm . I located a link to the same page within a separate piece of pharma communication using this url – https://www.accessdata.fda.gov/scripts/medwatch/ .

    The online option has apparently been available for some time. But again, that is not commonly known. And FDA even offers a widget which can be placed on websites and blogs, see http://www.fda.gov/Safety/MedWatch/ucm128254.htm (page last updated 6/19/2009).

    So perhaps you can help me spread the word link to my post at HealthCentral which provides information which should be understandable to the average patient. http://www.healthcentral.com/multiple-sclerosis/c/19065/95209/adverse

    Thanks,
    @LisaEmrich

    BTW, I have enjoyed following the discussion surrounding pharma/social media.
    .-= Lisa Emrich´s last blog ..Patients for a Moment at ChronicBabe =-.

    • http://www.doseofdigital.com Jonathan Richman

      Thanks, Lisa.

      Perhaps “MedWatch is dead” was a bit of an overstatement (a bit of poetic license I suppose), however, I do believe that in its current format it isn’t valuable to consumers nor is it likely to entice them to actually submit adverse events. It needs some fundamental changes to ensure that patients feel like they get some value out of going through the trouble to fill out a form or call someone on the phone. Either way, it’s 15-30 minutes out of their lives and for what? What’s in it for them? Until FDA can answer this question, it will never be as effective as it could be in collecting adverse events. So, perhaps “MedWatch is dead” was an overstatement, but I wish the current format WAS dead and replaced with something that consumers are far more likely to use, which in the end, will benefit everyone.

  • http://brassandivory.blogspot.com/ Lisa Emrich

    I agree that it could be must more user-friendly. Most folks aren’t going to go through the amount of pages I did just to see what information (in total) was included on the pages. It should be rewritten and redesigned to appeal to a wide range of individuals. There is definitely much room for improvement.

    In the meantime, though, we should do what we can to talk about the benefits of reporting serious adverse events (and confusing labeling, etc) for the betterment of health in general and not expect that pharma companies or our doctors are the only ones capable and expected to speak up.
    .-= Lisa Emrich´s last blog ..Patients for a Moment at ChronicBabe =-.

  • http://brassandivory.blogspot.com Lisa Emrich

    I agree that it could be must more user-friendly. Most folks aren’t going to go through the amount of pages I did just to see what information (in total) was included on the pages. It should be rewritten and redesigned to appeal to a wide range of individuals. There is definitely much room for improvement.

    In the meantime, though, we should do what we can to talk about the benefits of reporting serious adverse events (and confusing labeling, etc) for the betterment of health in general and not expect that pharma companies or our doctors are the only ones capable and expected to speak up.
    .-= Lisa Emrich´s last blog ..Patients for a Moment at ChronicBabe =-.

  • http://www.blog.virgohealth.com/ Ed Purkis

    More learnings for us in the UK – thanks for sharing the slides Jon. Particularly interested to see only 1 in 500 posts qualifies as a ‘reportable adverse event’. Legally, it’s always going to be a barrier to pharma communicating online in the UK, although this kind of thing definitely helps to calm the nerves of our (understandably) cautious pharma colleagues and feel more comfortable about other forms of online engagement.

    Look forward to seeing how things develop. Keep us updated – the blog is great!

    Ed

    http://www.blog.virgohealth.com
    .-= Ed Purkis´s last blog ..Pharma online: Are we wanted? =-.

  • http://www.blog.virgohealth.com Ed Purkis

    More learnings for us in the UK – thanks for sharing the slides Jon. Particularly interested to see only 1 in 500 posts qualifies as a ‘reportable adverse event’. Legally, it’s always going to be a barrier to pharma communicating online in the UK, although this kind of thing definitely helps to calm the nerves of our (understandably) cautious pharma colleagues and feel more comfortable about other forms of online engagement.

    Look forward to seeing how things develop. Keep us updated – the blog is great!

    Ed

    http://www.blog.virgohealth.com
    .-= Ed Purkis´s last blog ..Pharma online: Are we wanted? =-.

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