Time for Me to Eat Crow: FDA is Holding a Hearing on Social Media After All

First, congratulations are in order.

No doubt due to the groundswell of calls by the industry for social media directives, if you haven't heard by now, FDA has announced a hearing on the "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools." See the official notice from FDA here, dated Sept. 21.

Fellow pharma blogger John Mack first broke the news (a fact of which he is understandably proud!) on his blog Sept. 19. The announcement follows a long line of calls from the industry for a hearing on the subject.

FDA has said it’s going to listen to us. Whether they do anything with our suggestions is another matter. And I must admit I never thought it would happen. I’m eating crow, because I’d once tweeted the following, as quoted on the eyeforpharma blog:

FDA will never address this ... they've never addressed online channel at all except to say same rules apply

At least when I am wrong, I admit it. Heck, I even call attention to it. But surely I'm not the only one that was surprised? Weren't you?

Anyway ... it's time to get prepared.

To comment, submit your opinions, or request to attend or even speak at the event, visit http://www.regulations.gov/ and search by the document type "Notices" and document number fr21se09-58. Last time I was on the site, this one was showing up as a "hot" item in the list at the bottom, which will save you some search time. (A warning: this is a gov't site obviously built by the lowest bidder and is difficult to navigate. Interestingly, a poll on the site asked me what social media functionality I’d like to see there in the future! But I digress ...)

From there, you will "Submit a Comment" which is for any of these three actions:

1. Submit your comments, opinions, and ideas for consideration in connection with the topic (they may become public record so it's definitely not the place for your random rant)
2. Request to attend the event - be sure to include your contact information since they don't actually supply a form for that info.
3. Request to speak at the event - Again, be sure to include your contact information.

I wasn't sure the above direction was correct, so I actually called the regulations.gov Help Desk. They were very helpful! Once your comment/request is submitted, you will receive a confirmation number.

Note these key dates:

• Oct. 9 - Deadline for registration to attend and/or to participate in the meeting; accepted on a first-come, first-served basis.
• Nov. 12 - 13: Public Hearing in D.C.
• February 28, 2010: All comments due, which can be submitted via snail mail or the above mentioned Web site.

The hearing is not far away. 49 days to be exact, but who's counting?

Again, FDA has asked what we think. It’s our turn to tell them … in a thoughtful, reasonable, realistic manner, of course, and with data to back it up.

I know I’m getting my thoughts organized, how about you?
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P.S. - I was traveling 9/21 when the news was all over Twitter, so I missed the #FDAsm TwitterFrenzy. But I've now had a chance to not only review the notice but also read what other bloggers and media had to say; below are a few worth reading:

• John Mack’s original post and his survey on the subject
• Five myths surrounding FDA & media - a good reality check for us all
• Advertising Age article and comments – Because it’s always interesting to see non-pharma advertisers weigh in on pharma-centric issues.
• John Mack’s Official FDA Hearing T-shirt – have you ordered yours yet?