Whew! On Monday FDA quietly issued draft guidance titled, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”
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.
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who have been cautious and/or are awaiting guidance will appreciate what is likely just one more in a series of draft guidance documents laying out the FDA’s thinking on the topic.
By way of quick summary, the draft guidance document: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.