Analysis of FDA’s social media guidance for RX

Our W2O Group hosted a webinar today (full link at bottom of this post) featuring a panel of our regulatory, corporate communications and social media experts to discuss an overview and potential implications of the FDA’s long-awaited draft social media guidance. Hopefully, this is the first step toward having more comprehensive guidelines to help pharma navigate the rules of the road for social media. To date, given the lack of definitive guidance, we have had to rely primarily on warning letters and employ common sense to help us cautiously steer the course and build engagement.

The FDA has described this guidance as pertaining to “Interactive Promotional Media” that aim to help healthcare companies determine if electronic communications using social technologies are subject to FDA’s post-marketing submission requirements. This is most impactful for branded, promotional communications.

Key Takeaways:
1. Be accountable for YOUR content
: This means not only content that your company produces, but also covers content generated by employees, agencies, KOLs, brand ambassadors, contracted sales reps, etc.


FDA_Guidance_Cover2.
The guidance gives brands more clarity on what is and isn’t within FDA’s promotional jurisdiction: For example, if a company provides only financial support, but doesn’t control or influence content, the company is not responsible for what goes there. However, companies still must share anything that they submit to a third-party if it’s posted on digital platform.

3. User generated content (UGC) is primarily the user’s responsibility: The guidelines also take pains to clarify a company’s responsibility toward content from independent third parties — even if it happens on a brand’s own Facebook page, blog or forum. A company generally is not responsible for UGC content, and FDA won’t ordinarily view UGC on company-owned or company-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 company and the company had no influence on the UGC. 

4. Brands can (cautiously) practice real-time social media: When brands engage online, they don’t have to submit content for FDA review before it is disseminated through their channels. This further opens up the opportunity for brands to do real-time engagement (e.g. respond to Facebook posts, comment on a blog). The FDA makes it clear, however, that companies must collate all content they have developed and submit for review on a monthly basis.

5. So, what does this mean for your company’s social media properties? Our guidance is that, for now, we should continue running social media properties with a “business as usual” attitude, which is rigorous and vigilant in terms of review process, particularly with ambassadors, KOLs or other partners.

More definitive guidelines from the FDA are expected in July, but FDA has historically had shifting timelines, particularly around social media guidance.

One question that’s still outstanding is what will be necessary from a safety standpoint/fair balance in branded social media posts, especially when using a platform like Twitter that limits you from including that safety information. According to John Mack of Pharma Marketing Blog, this guidance is expected later this year. 

Webinar_screenFDA Social Media Draft Guidelines Webinar: Friday, January 24, 2014
https://w2ogroup.webex.com/w2ogroup/lsr.phpAT=pb&SP=MC&rID=40406592&rKey=8997212f3ded6151

Susan Parker
Susan Parker