By Scott Hensley
Tweet this! Just in time for Web 3.0, the Food and Drug Administration has set a date this fall for a public hearing on how to deal with Web 2.0.
As is the modern fashion, the FDA wants your help in figuring out what to do about advertising and promotion of regulated products on the Internet. You can find the info on how to submit comments or attend the meeting, scheduled for Nov. 12 and 13, in the Federal Register here.
The announcement includes a helpful primer on such obscure terms as podcast, blog, and social network, where people with common interests can "create profiles and then invite people to join as 'friends.' " Oh, really?
Seriously, this is important stuff, so we figure the agency has to make sure everyone understands the basics.
Lots of folks have been wondering why it has taken so long for the agency to get around to laying down rules for the Internet road.
Critics say companies have exploited the regulatory void. While many in industry say the Internet is a minefield whose risks are compounded by unexpected agency crackdowns, like the flurry of warning letters on Google search ads in March.
At a meeting of lawyers who deal with FDA this morning, Janet Woodcock, head of the agency's drug center, said there's a renewed focus on policing advertising. Drugs, medical devices and so on, are more complex, and there have been enormous changes in the way people communicate, the use of social media, according to Mark Senek, who blogs at Eye on FDA.
So, what are the questions FDA has in mind? We paraphrase below:
1) What online messages and chatter are regulated companies responsible for? And what's not their problem?
2) How do companies comply with existing regulations, requiring such things as fair balance in ads, within the confines of, say, a 140-character tweet?
3) When does a company have to correct misinformation posted by third parties? Hello, Wikipedia! Some companies, the FDA said, haven't taken action on known problems, fearing they'd then be responsible for correcting everything anywhere online.
4) To link, or not to link? is the FDA's question. Specifically, FDA wants to know what sorts of linking is appropriate and when users find it misleading.
5) The bogeyman in the social media closet has long been chatter about side effects and other problems with products. When do companies have to report these bad experiences as recounted on the Web to FDA?