CU Bhind gym 2day 4real, LOL -FDA

Tuesday, July 19, 2011

I have to say, I have really mixed feelings about FDA being on Twitter. On the one hand, seeing them go for it is part of what pushed us to take it on. On the other hand, there's something inherently silly about the juxtaposition of stodgy and youthful. It's like Betty White rapping on the couch with a couple strapping young hipsters, if you can imagine that.

Oh wait... that actually happened.

In any event, at 3pm ET 2day, I went to the duly-appointed hashtag to learn what I could.

The main thing I learned is that this was a far more interesting and useful event than I expected it to be. I expected a lot of cross-talk and uninformed questions. There was some of that, to be sure, but surprisingly little.

What I saw instead was FDA successfully getting out ahead of the misunderstandings that their new guidance was likely to create among app developers. Although there's very little in the mobile app guidance that will surprise a seasoned device industry person, FDA clearly understands that they're talking to people who, by and large, are not seasoned device industry people.

The guidance itself is written in remarkably plain language and people at the chat seemed to get what FDA was trying to say: your entertainment and "personal wellness" apps are cool... but if you're selling software that diagnoses or treats disease, it's not exempt from regulation simply because it's on an iPhone.

On mobile devices, it's all about your intended use and the claims you make... just like it is with pretty much everything else. Taking a picture of your rash with an iPhone does not magically transform it into an FDA-regulated product. Analyzing EKG data on your iPhone does make it an FDA-regulated product. Bottom line: FDA is not crushing a nascent industry and all is well with the universe after all.

As a side note I can't help but wonder if FDA will be able to get away with pinning all the responsibility on app developers and none on the software distributors (such as Apple / Google). The guidance specifically names iTunes as being an example of a "distributor" but is it truly the case that they "exclusively distribute mobile medical apps, without engaging in manufacturing functions"? It should be interesting to find out. If FDA is going to regulate what is sold in the US, but not what is sold outside of the US, it's difficult to imagine how they will do that without having some kind of conversation with the only parties who are in a position to control what is sold where.

Whatever happens next, FDA has to be applauded for giving this a try. For how careful and circumspect they are normally, I can't imagine that they were comfortable being bombarded by questions so publicly and so quickly. By my count, more than 500 tweets sailed by in a single hour... that's not a lot by Internet standards, but it's a whole lot more discussion and chaos than your typical public meeting. All in all, it was a good day for the agency.

Tags: Advertising & Promotion, FDA, Industry

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