Today the Food & Drug Administration announced that they are going to wait until at least the first quarter of 2011 to give the world official guidance on social media. Mark Senak’s blog post gives us a glimpse into what the FDA is thinking with the delay and the official statement from the FDA:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
I understand the FDA wants to ‘get it right’ but what the industry really needs now is strong guidance and a sense of direction. I can’t tell you how many times I have spoken with clients who are looking for the right answer but know in the current market there isn’t one.
Personally I can’t fault the FDA for postponing the decision but I can shake my head a little. I come from the ‘social media world’ and the traditional world of PR and marketing. I remember discussing with clients years ago about the best way of marketing with social media and they always asked if the FCC would come after them for doing certain things. Granted, the charge of the FCC is very different from that of the FDA, but in all honesty, if one government agency can figure it out why can’t all the others? Even the Department of Defense has a social media policy.
Perhaps that is the best way to look at it: both the Department of Defense and the FDA deal with life and death situations–if the DoD can figure out social media, why can’t the FDA? The DoD realized a few years ago that people were going to use social media. Left unchecked, social media usage could have been very dangerous for the DoD and those it protects. With this in mind, the DoD set some stringent guidelines, as well as according punishments, for social media use. The FDA needs to take the same approach by offering strong guidelines, and in turn, consequences if those guidelines are not met.
Everyone in the industry is waiting to come out of limbo, everyone wants a clearer definition of what can and cannot be done. According to today’s announcement, for a bit longer the industry will have to hold its breath and wait to see if they can or cannot maintain these connections with the people they help.
Is the FDA hurting or helping the industry? That is of course a matter of opinion and hindsight. If the FDA takes a few extra months to figure things out and then ends up getting it right, then that is great. But if after a few months, they fail to give other PR and marketing professionals like you and me the guidance we expect, then they have hurt the industry.
What is your opinion on this? Do you think the FDA’s delay on this will pay off or is it just hurting the food and pharmaceutical industry even more?
Tags: fda; social media
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