Wednesday, January 15, 2014

FDA Draft Guidance Opens Up Social Options for Pharma

In language that you and I can better understand, that means FDA is seeking to answer some of the industry's social media questions such as, "What are the expectations around the frequency of submission of a dynamic page – such as a Twitter account or a blog that hosts commenting – to FDA?” “What triggers a 2253 when it comes to social media?” “How do I report if a representative of my company posted a comment on someone elses’ site? Should that trigger a 2253?”

While the FDA hasn't said a whole lot about it, the industry is already abuzz.

Here's why:  Though it is currently "draft" guidance, it does have implications for how pharma and animal health companies engage in and report their social media promotional activity. So if you are a pharma marketer who is currently using social media for your brand -- or is thinking about doing so soon -- you should be paying attention.

To be clear, the document is not comprehensive “social media guidance,” rather, it is another in a series of guidance documents following the 2009 hearing addressing the ever-changing world of digital and social communications.  According to the FDA web site, FDA is developing a variety of guidance concepts, including:
“… how companies should respond to unsolicited requests for information about off-label use, issues with space limitations, fulfilling post-marketing submission requirements, accountability, use of links on the Internet, and how sponsors should correct misinformation about their products disseminated by third parties.”
Pharmaceutical and animal health companies who are already active in social media will appreciate FDA providing clarity on some topics, such as clarification that FDA won’t hold companies responsible for truly independent user-generated content, even on a company’s own channel. Companies who have been cautious and/or are awaiting guidance will appreciate what is likely just one more in a series of draft guidance documents laying out the FDA’s thinking on the topic.

By way of quick summary, the draft guidance document:

  • Recognizes the challenges of submitting promotional materials that display “real-time” information, such as user-generated content (UGC).
  • Recognizes that there is a difference in interactive, dynamic content vs. static content, and that it may make sense for postmarketing submissions of these types of content to be handled differently.
  • Lays out FDA’s thinking on the difference between company-controlled and independently-generated content, and where these types of content fall within FDA’s regulatory purview.
  •  Provides recommendations for how to properly submit and/or resubmit promotional materials that include UGC using Form 2253 (human health) or 2301 (animal health)  in situations such as:
    • A company-owned product website includes a “real-time” dynamic component such as a blog.
    • An employee or designated agent (agency, KOL, paid blogger) of the company posts on behalf of the company to a third-party Web site.
  • Applies to branded promotional materials regardless of the target audience (consumer, HCP, other).
  •  Provides a number of helpful examples, similar to what was seen in recent mobile guidance.

Intouch Solutions will be publishing our formal POV publicly very soon. [*UPDATE: We published it here.]

I am confident this is just the start of one of the more interesting conversations around regulation of social media for some time!

I, for one, am excited.


Jeff Greene said...

No question Wendy - you're right to be excited. Consumers should be too. It will take time, but there is a lot in the document that suggests FDA wants manufacturers to feel comfortable interacting with patients and docs online. (As long as certain guidelines are respected.) So .. was it worth the 4-year wait?

Wendy Blackburn said...

Ha - well, considering there was always a chance we'd never get ANYTHING out of FDA, I'd say yes - it was worth it. But let's put a reminder on our calendars for one year from now to revisit that thought. The question now is ... how fast can pharma change their mindset accordingly? Thanks for your comment and the kind words.

Wendy Blackburn said...

Good find from John Mack: FDA Publishes its 2014 Social Media Agenda

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Jupiter Ascending said...

Well, there does need to be assistance.