08 January 2012
FDA Issues a Guidance and the Social Media World is Disappointed…hmmmm
01/11/12 22:35 Filed in: Social Media Regulation | Off-label promotion
FDA issued a guidance document in late December on responding to unsolicited requests for medical information. Lots and lots and lots and lots and lots of people have anticipated this and have described this as a "social media guidance." It isn't. Never was and never could have been. Of course, it's not entirely unreasonable for people to have this impression since FDA touted this particular guidance document (prior to its issuance) as a social media guidance (of sorts). On multiple occasions, FDA personnel announced at public meetings that this guidance was a part of its efforts to provide guidance on social and electronic media. But its not very instructive when it comes to the multitude of platforms and possibilities that drug, biologic, and medical device manufacturers have to communicate in new media spaces. That's bad news for all the media agencies and pundits and consultants who are living and dying in the new and social media space. But there's good news!
The good news for drug, biologic and medical device manufacturers is that the guidance is good, and useful, and clarifies an issue even more desperate in need of clarification than social media. The entire concept of the unsolicited request is an industry convention that lacks any formal acknowledgment in the law and regulations, and is practiced widely every day by companies and even enforced by FDA and the Department of Justice. In a way, FDA is providing guidance on something that isn't even really the law (at least explicitly). Overall, I don't find anything entirely surprising about the guidance document. It aligns squarely with my thinking on how FDA thinks (not necessarily how I think, but I get paid to think about how FDA thinks about things).
So anyway, I was on twitter and I saw that someone had catalogued a bunch of articles on FDA's social media guidance and was disappointed to see so many articles waxing poetically about what the guidance means or doesn't mean for social media and FDA guidance on social media and I just have to step back and acknowledge that the guidance wasn't a social media guidance. If you thought it was, perhaps you were mislead. I don't think FDA meant to mislead you, but they all along told the public that this guidance was about responding to unsolicited requests and said they would include some content on what this meant in social media. I think FDA misjudged how many people were going to misunderstand what this meant. This is not FDA's reaction to the 2009 public hearing, it is a sign of how FDA is reacting to the public hearing. Slow and deliberate slow deliberation.
Anyway, sorry for a lack of true analysis of the guidance. In a way I feel like this blog post is a total cop out. But the fact is, as a regulatory professional (who also engages in social media), I am too busy dealing with other regulatory issues (like making sure companies response appropriately to unsolicited requests), than to pundit today about FDA's social media guidance approach. I don't mean at all to sound smug either, but this is an indication of FDA's approach to its regulatory priorities. FDA has lots of other issues to tackle along with social media. Moreover, I do believe that FDA has social and electronic media as an important guidance and enforcement priority. However, they have too much to lose by getting a guidance wrong, so they're gonna work sloooooooowly. Expect maybe, maybe, one or two guidances over the next 5 years. Maybe even one that focuses solely on social media.When that one comes out, expect FDA to articulate how the regulations apply to the media, but don't expect FDA to articulate how you can use new media and comply with regulations (that's not really FDA's job). It is possible that many platforms cannot comply with regulations, or that once you apply FDA's guidance you will come to that conclusion. I guarantee one thing. Whatever guidance they issue that everyone is longing for…this guidance… will be sure to disappoint anyone who is expecting the guidance to open up the floodgates of business opportunity.
The good news for drug, biologic and medical device manufacturers is that the guidance is good, and useful, and clarifies an issue even more desperate in need of clarification than social media. The entire concept of the unsolicited request is an industry convention that lacks any formal acknowledgment in the law and regulations, and is practiced widely every day by companies and even enforced by FDA and the Department of Justice. In a way, FDA is providing guidance on something that isn't even really the law (at least explicitly). Overall, I don't find anything entirely surprising about the guidance document. It aligns squarely with my thinking on how FDA thinks (not necessarily how I think, but I get paid to think about how FDA thinks about things).
So anyway, I was on twitter and I saw that someone had catalogued a bunch of articles on FDA's social media guidance and was disappointed to see so many articles waxing poetically about what the guidance means or doesn't mean for social media and FDA guidance on social media and I just have to step back and acknowledge that the guidance wasn't a social media guidance. If you thought it was, perhaps you were mislead. I don't think FDA meant to mislead you, but they all along told the public that this guidance was about responding to unsolicited requests and said they would include some content on what this meant in social media. I think FDA misjudged how many people were going to misunderstand what this meant. This is not FDA's reaction to the 2009 public hearing, it is a sign of how FDA is reacting to the public hearing. Slow and deliberate slow deliberation.
Anyway, sorry for a lack of true analysis of the guidance. In a way I feel like this blog post is a total cop out. But the fact is, as a regulatory professional (who also engages in social media), I am too busy dealing with other regulatory issues (like making sure companies response appropriately to unsolicited requests), than to pundit today about FDA's social media guidance approach. I don't mean at all to sound smug either, but this is an indication of FDA's approach to its regulatory priorities. FDA has lots of other issues to tackle along with social media. Moreover, I do believe that FDA has social and electronic media as an important guidance and enforcement priority. However, they have too much to lose by getting a guidance wrong, so they're gonna work sloooooooowly. Expect maybe, maybe, one or two guidances over the next 5 years. Maybe even one that focuses solely on social media.When that one comes out, expect FDA to articulate how the regulations apply to the media, but don't expect FDA to articulate how you can use new media and comply with regulations (that's not really FDA's job). It is possible that many platforms cannot comply with regulations, or that once you apply FDA's guidance you will come to that conclusion. I guarantee one thing. Whatever guidance they issue that everyone is longing for…this guidance… will be sure to disappoint anyone who is expecting the guidance to open up the floodgates of business opportunity.
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