If someday it should happen that draft guidance must be sound
I’ve got a little list. I’ve got a little list
Of social media platforms where user content can be found
And if a product’s disssed it never will be missed.
Some further thoughts on the FDA’s latest social media operetta, the draft guidance entitled, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” – or as fans of Gilbert & Sullivan might prefer to call it, “Patience.”
The real nugget is to be found between lines 188-193:
However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.
In it’s September 21, 2009 Federal Register notice (the one that announced the now famous November 12, 2009 Part 15 hearing), the FDA asked about the issue of property owner vs. property user and user-generated content more broadly:
When should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?
As I testified at the hearing, “Would letters to the editor be liable for an FDA warning letter? What about radio call-in comments? What about freedom of speech? Relative to intended to promote -- how can this be differentiated from intended to share and educate? And whose job is it to define such differentiation? As Don Draper said, I'm enjoying the story so far, but I have a feeling it's not going to end well.”
(For my complete Part 15 testimony, see here.)
Four plus years later, the property owner vs. property question is asked and answered. So far so good on the UGC front. Better late then never.
Now the question is, does regulated industry really want uncontrolled, unfiltered, and unpredictable user-generated comment on their sites? Because, let’s be honest, it ain’t all gonna be pretty. Is Big Pharma ready to mix it up in real time with real people?
On another note, there’s a peculiar little codicil in the draft guidance that appears on lines 246-249, to wit:
Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real- time communications with the monthly updates.
Hugely cumbersome? To be sure. But what’s really troubling is the good folks at OPDP think such a “running list” is even plausible. Do they really think that regulated healthcare companies are centralized to such a degree that any one person or department knows the full extent of social media participation? And even if this was the case, is this information really any business of the FDA? Are companies currently required to submit their media plans along with creative for agency review – on a running basis no less?
And just who is going to review these lists? What are the qualifications of such reviewers? Since OPDP isn’t hiring, where in the review queue will these lists reside? Will they be made public? This is mission creep extraordinaire. Danger, Will Robinson. Danger.
Like Old Man River, social media keeps on rolling along with or without FDA guidance (draft, bottled, or otherwise). List making isn’t going to limit it. And no amount of hoping/wishing/praying is going to make it static. Social media jes’ keeps on rolling along.
And regulated industry jes’ keeps falling further and further behind the curve.
How can the FDA help to facilitate, encourage, and expedite more activity on the part of regulated industry? After all, as Janet Woodcock has said, “Social media is where the people are.”
The answer isn’t “more process.” It's more prowess.
And maybe it's time for another Part 15 hearing.
