Wednesday, October 28, 2009

Expect FDA Social Media Draft Guidance Before End of 2010

Let me make a prediction: FDA's DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here).

Yesterday, at the ePatient Connections 2009 conference, I was a member of the Regulatory Panel that also included my friend Preeti Pinto, MS, MT (ASCP), Head of Medical Education and Regulatory Compliance at AstraZeneca, and Paul Loebach, Project Manager, DDMAC. I never met Loebach before, but I liked him even though he never fully revealed what he has been doing at DDMAC for the past 18 years.

During that panel discussion, Loebach informed the audience that it was too late to request a seat at the upcoming November FDA public hearing on social media. Over 800 people applied for seats, but the meeting room can only accommodate 350. Pharmaceutical Executive Magazine, for example, won't have a seat (see "Fear and Loathing in Washington, DC").

Someone in the audience asked Loebach and other panel members what their thoughts were regarding some best practices for using social media to get information out to consumers/patients. I would have responded by pointing out that one best practice for using social media was not to push info out to an audience, but to engage members of that audience in dialogue. But I let Loebach answer the question -- I'll have more to say about social media best practices in a follow-up post.

Loebach, speaking for himself and not DDMAC, suggested it was "too early" to offer advice and that DDMAC was "still fishing for information." He also said something I thought was revealing: ie, "we have ideas." Of course, by law, DDMAC has to solicit opinions of the public before it issues guidance and that's what the November hearing is about. "We still need to hear from everybody, because we're on the other side of the fence and we can't think of all the issues that you all will come up with and all the ways to use social media that you will come up with in the future. I know a lot of you in the audience feel that this hearing coming up in November is long overdue, but we're still too early in the learning curve to start giving advice on what will work and what won't."

This prompted me to ask Loebach: "Do you personally think the FDA will come out with some kind of guidelines relating to social media by the end of 2010?"

After a brief dramatic pause, Loebach responded "Yeah, probably that's a good estimate -- by the end of 2010. But if it happens earlier, even better," said Loebach hopefully.

This is as close as you're going to get for an official estimate of when FDA may publish social media guidelines. I happen to believe it is accurate not just because of what Loebach said, but because the FDA needs to prove that it's not your father's FDA. The new FDA leaders are younger than the previous leaders. They are smart people who believe in and have grown up using new media tools like social media. Besides, the FDA will lose tremendous face and credibility if, for the second time, they fail to act after calling a public hearing on the use of the Internet. This time they mean business.

3 comments:

  1. I certainly hope you're correct on this account! I'd love to see the FDA move before the end of this year. Thanks for the insight.

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  2. I hope your optimistic view on the FDA's willingness to issue guidance turns out true. Perhaps I am jaded, but I am preconditioned to believe this will be a long haul. But as we touched on earlier, it's really about the beginning of a discussion that at least moves this in the right direction.

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  3. The FDA will most certainly issue social media guidelines. The Internet is the "Wild West" so to speak, a space that is not well controlled and "anything goes". If pharma companies are allowed to run-a-muck on the Internet, they definitely will. Since social media is so new to marketers, their aren't any rules to follow, but some tips provided by the pros. The FDA will want to control how pharma companies use the web to market their products and ideas, and quite honestly, I think it's a good idea.

    http://www.garfieldgroup.com/thelab

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