Last Updated Sep 22, 2009 12:21 PM EDT
BNET noted yesterday that industry has been complaining for years that that brand managers do not know how far the FDA will allow them to go in media such as Google ads, Twitter, Facebook, and even on their own web sites. Put a foot wrong, however, and FDA is swift with the warning letters.
In the FDA's notice on the subject, it listed these reasons for the hearing. Am I reading too much into them, or do they sound like mea culpas?
The continually evolving nature of the Internet, including Web 2.0 and social media tools, as well as their expansion to applications such as mobile technology, have raised questions and concerns over how to apply existing regulations to promotion in these newer media.
... the agency believes that many issues can be addressed through existing FDA regulations, special characteristics of Web 2.0 and other emerging technologies may require the agency to provide additional guidance to the industry on how the regulations should be applied.The FDA notes that the last time it addressed the web was ... 1996. Here's a transcript of that meeting. If you have a spare 20 minutes on your lunch break, read the section titled "World Wide Web 101." In it, Sandy Desautels of the National Institutes of Health Division of Computer Research and Technology gave attendees an intro to what, exactly, the web was. It is by turns charming and laugh-out-loud funny. Here are some highlights from sections that have not stood the test of time:
FDA has not comprehensively addressed when Internet promotion of prescription drugs and medical devices is labeling versus advertising...
There are no regulations that specifically address Internet promotion separately from the other types of promotion discussed above, nor are there any regulations that prohibit the use of certain types of media to promote drugs and medical devices ...
FDA recognizes that the Internet possesses certain unique technological features and that some online tools that may be used for promotion offer novel presentation and content features.
What is the Internet? The Internet is a network of networks. ... Internet Relay Chats, IRCs; those are chat rooms. ... Where does the Web fit in to this whole thing? The Web is a service on the Internet. It's only one small portion of it. It's a lot newer. ... Hyperlinks are those lovely little blue text items. If you've ever been on a Web page, you see those little things highlighted in blue. Those are links to both documents that can be on the same server, they can be in the same building, they can be in the same country, they can be in a completely different country.
Great! You want to get on the Web. What do you do? How do you get started? You need four things to get started. First you have to have a computer; makes sense. It can be a PC; it can be a Mac; it can be a Unix machine. It doesn't matter. You have to have a connection to the Internet. Most government agencies already have this. Home users, it used to be very difficult. Now, I mean, there's Erol's, ten bucks a month. Everybody's selling connections to the Internet. And you need a modem, if you don't have a direct connection.
You need a Web browser, an application you are going to run on your computer which is going to display Web documents. I am using Netscape Navigator right now to do this presentation.Your tax dollars at work! Anyway, doesn't everyone now know that the interweb is a series of tubes?
Disclosure: The author once had a $10 Erols account. Now he pays Comcast $142 for the same thing plus TV and phone. Progress?