FDA Open Hearing on Internet and Social Media

POSTED BY: Shwen Gwee (Med 2.0 Blog)

NOV 12-13 marked a VERY significant occasion in the history of social media in pharma. By that, of course, I mean that it was the much anticipated FDA Open Hearing on Internet and Social Media — the first of it’s kind since 1996! Of course, it was just “Internet” back then — social media didn’t exist as we know it today.

The biggest irony of this meeting on INTERNET and SOCIAL MEDIA is that there’s no wifi connection or cell phone reception (the meeting room is 2 floors underground), so no one there will be able to live tweet/blog the meeting, but at least it’s an open forum. Whatever the case, those of us watching the live webcast will be live-tweeting (because we have wifi! đŸ™‚ ) using the hashtag #FDASM, so look out for those.

FDASM_01.jpg
Click image for live webcast on NOV 12-13

There’s already been bevy of write-ups and resources surrounding this, so rather than write my take on it, I’m going to point to several of these so that you can get a variety of viewpoints and information…

FDASM_02.jpg

First and foremost, if you have only one resource to turn to, then you must go to FDASM.com — a site put together by Fabio Gratton (Ignite Health), which aggregates a lot of key information around the event, including: speakers, panelists, agenda, links to the webcast, a live tweet-stream, and (most importantly) a list of logos from supporting groups/people, which there are plenty! In addition to that, here are some links to great information surrounding this historic event:

UPDATE (Nov 12th, 2009): Day 1 Summaries and New Links/Resources…
UPDATE (Nov 13th, 2009): Day 2 or Overall Hearing Summaries/Links/Resources…

Wordle: #fdasm FDA & Social Media Twitter Stream Nov 12-13

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FDA Launches Twitter Feed and Calls for Public Hearing on Social Media & Internet

In case you haven’t already heard, the two big pieces of news in the Social Pharmer world (over the last couple of weeks) both have to do with the FDA…

FDA Launches Official Twitter Feed
Firstly, the FDA launched it’s official Twitter feed on Sept 11th: @FDA_Drug_Info. You can find their Twitter information page here, which includes information on “Available Twitter Feeds” (I’m guessing that means they’re planning more than one Twitter feed in the future) and associated disclaimers. Not surprisingly (I guess), their disclaimer states “We are not able to respond to replies or direct messages. Please do not reply to tweets with any private, personal, or proprietary information. Send questions, comments to: druginfo@fda.hhs.gov or call 1-888-INFO-FDA“, which means that — for them — Twitter is merely another channel for disseminating information via one-way communications — not a medium for interaction or conversation.

While social media “purists” may call this heresy, I think it’s a reasonable initial approach (though they did launch FDArecalls a few months back) and even encouraging that they have at least taken the first step to try it out for themselves. However, others may refer to it as the Irony of Ironies, since we are all painfully aware of the fact that industry guidelines (currently) DO NOT exist for even the Internet, let alone social media. We’ll see how things evolve in the near future.

FDA Calls for Open Hearing on Social Media and Internet
Speaking of evolution…

In a surprise announcement last week (SEP 18th), the FDA filed a Notice of Public Hearing “…to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools“. The hearing will be held on NOV 12-13, 2009 in Washington, D.C. Here’s more from the notice…

FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.

While this announcement may be surprising to many, it’s been something that folks like John Mack have long asked for and discussed over the course of the last few months (it was also a big topic at the Social Pharmer Unconference earlier this year), as social media started to rise in popularity within the industry.

As you can imagine, the announcement has also drawn a lot of interest and chatter from the Social Pharmer crowd and here are some links to what are being said around it:

  1. Ignite Blog: BREAKING NEWS: The FDA calls for a public hearing to discuss promotion of FDA-regulated medical products using the Internet and social media tools (NOTE: this is where I heard it first)
  2. Pharma Marketing News: Pharma Influence Over 3rd-Party Conversations in Social Media
  3. Eye on FDA: FDA to Hold Part 15 Hearing on Social Media and Pharma – Finally!
  4. Walking the Path Blog: Why Non-Pharma Marketers Should Care About the FDA Public Hearing on Drug Promotion & Social Media
  5. Impactiviti Blog: Coming Up: A Big Week in Pharma Social Media

If you’re interested (and you should be) in following the conversation on this topic, the hashtag that has been established is #fdaSM. And if you’re thinking about playing a more active role in this, you should (1) read and take John Mack’s survey, (2) read Mark Senak’s blog on “What Companies Should Do Between Now and The Part 15 Hearing on Social Media“, and (3) register to attend the event in NOV at regulations.gov — see “How To Register for FDA’s Part 15 Meeting on Social Media” for help.

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