FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products http://t.co/lV3QZYkDWn
— U.S. FDA (@US_FDA) June 17, 2014
Paging Dr. Oz: the FDA has finally, officially made statements to the effect that the companies selling the sedatives required in order to watch your show should practice a bit of honesty on social media.
They’re only suggestions in draft form at the moment…so in the words of Donald Draper, “Take a pill and lie down.”
Now let’s check out those guidelines.
The reasoning behind the FDA’s decision is quite obvious: lots of people get information about (legal) drugs and medical devices on social, and it’s long past time to hold the companies and/or blogs promoting them accountable when they spread false or misleading information–even if it’s user-generated.
The main point of the first of two drafts concerns the difficulties in explaining risks/benefits of drugs in 140 characters while the second addresses the challenges of correcting misinformation as it appears on third-party sites or social forums.
In short: on Twitter, link to an existing resource with approved information about your products.
And when someone makes false claims about said products (be they positive or negative), use the forms and/or comment sections to gently correct that UGC. Here’s a key statement:
“FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.”
So the FDA appears to be flexible on this topic, which is encouraging news for the many firms that might otherwise hesitate to address claims made about drugs by random people on social. Here’s another key point:
“…a firm’s control over, involvement with, or influence over a product-related communication, even when generated by a third party, may result in the firm being responsible for the information as a promotional communication. Thus, firms might be responsible for UGC that they solicit or influence, regardless of the forum.”
In other words, if you in any way encourage UGC then you also bear some of the responsibility for it. Remember, this is all just a friendly suggestion:
“FDA’s guidance documents…do not establish legally enforceable rights or responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations”
Still, if you deal with any pharma or medical clients then you should read the drafts three times just to be safe.