FDA Issues First-ever Draft Guidance on Pharma's Use of Social Media ....Were You Fooled?
Posted by Ellen Hoenig Carlson on Thu, Apr 02, 2009 @ 03:54 PM
If you followed Twitter yesterday, you quickly learned that John Mack's Pharma Marketing Blog was indeed wishful thinking and an April Fools joke...
Today's post explains what was behind it...
"Now that everybody has calmed down about my April Fools joke (ie, "FDA Issues First-ever Draft Guidance on Pharma's Use of Social Media!"), we should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.
I suggested this in yesterday's post (see "FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!") because it seems that the FDA and some pharma companies are "mulling" this over behind closed doors and I want those doors opened. What do you think?"
On one hand, I certainly agree with John Mack's point that the door should be open for broader input than just a few pharma companies. On the other hand, if a few pharma companies are willing to step up and drive the process and thinking behind social media in pharma, I'm not so sure that's a bad thing as long as the guidance is issued as draft and circulated for public commentary (and the public input is taken seriously)
BTW....If you haven't listened to the 15 minute podcast that Mark Senak did with Dr. Jean Ah Kang, special Assistant to Tom Abrams at DDDMAC in charge of Web 2.0 policy development, entitled "A Converstation with FDA/DDMAC About Pharma, Social Media and Web 2.0", you may want to. While it's just the beginning of the dialog with pharma...Dr. Kang reinforces a few points, namely:
1. DDMAC recognizes the growing importance of social media and that it is here to stay...Dr Kang also recognized that 3rd parties can come in and alter communications, so it's about the pharmaceutical company's involvement and original intent...in other words, the pharma company is responsible for what they put into it...
2. "It's not the medium, but the message." Whether its social media or DTC TV, pharma companies must stay true to FDA regulations in terms of presenting their products with balanced risk/benefit information according to their approved label.
3 . Pharmaceutical companies are welcome to ask for advisory input to 'new' campaigns, including those that they will be running with web 2.0 media.
What do you think?