Alison Rogove's picture

FDA Webinar on Social Media Draft Guidances: Still Seeking Long-Awaited Clarity

[[wysiwyg_imageupload:212:height=154,width=188]]Healthcare consumers, patients and professionals are relying more and more on digital and social media forums, and online resources for medical and health information. Healthcare knowledge sharing via social media is also a growing practice. As digital and social engagement on health continues to grow, so do questions on best practices for industry, such as pharmaceutical companies. On July 10th, the U.S. Food and Drug Administration (FDA) hosted a highly-anticipated webinar and public Q&A session to discuss its stance on the use of social media by the healthcare industry (slides available here). Specifically, the FDA addressed three draft guidance documents it has issued in recent months, all with one common goal – to help shed some light on how the industry can join this powerful conversation.


What were the key takeaways from the FDA’s session?

Given the obvious power of social media and the many healthcare consumers and professionals who use it more and more each day, many participants had high expectations for this session. However, not much new information was offered (and the session was cut short due to – ironically – technical difficulties). Nonetheless, several broad considerations jump out as exceptionally important for communicators and public relations professionals:

  • New guidance for social media largely mirrors well-established FDA requirements for promotion of more traditional media platforms – including considerations for fair balance, transparency and reporting
  • While there are regulations on how companies can promote their products on social media, the FDA recognizes that companies cannot be responsible for all user-generated content related to their products, as much of this is beyond their control
  • Companies are allowed to be responsive when interacting with consumers on social media and the FDA guidance allows for manageable reporting of real-time content, but the inclusion of fair balance is a major hindrance, given space limitations inherent to social media
  • Product websites, mobile devices and online web banners are all outside the scope of the current guidance documents and have yet to be addressed by the FDA


How can we implement these new guidelines in our healthcare PR practice?

As PR professionals, the value in having our healthcare clients join in the social media conversation is self-evident. In addition to building brand recognition and loyalty, social media interaction can truly engage an audience and strengthen their emotional connections to brands. Social media prompts users to share experiences, and has the potential to help humanize the abstract or technical, and help lead to understanding, communication and overall reputation. However, it’s not that simple. A lack of clarity around rules and regulations for engaging in social media has left the otherwise heavily-regulated healthcare industry trigger shy. The good news is that’s all starting to change (or, at least one can hope!). And where’s why:  


The first guidance addresses how pharmaceutical and medical device companies should handle independent third-party misinformation, including user-generated content (UGC), regardless of whether it appears on a company’s own platform or a third-party site such as Facebook or Wikipedia.

  • Key Takeaway: Companies are encouraged (but not required) to voluntarily correct misinformation generated by a third party. The exception is when companies prompted or have influence over the misinformation – then of course, they are responsible for it.
  • Key PR Considerations: The industry has been largely hesitant to post branded content on platforms such as YouTube or Facebook in the past due to potential user comments containing adverse events or misinformation. The new guidelines offer reasonable and realistic measures the industry can take to address misinformation that could potentially be posted on these forums. Alternatively, companies can opt to turn off the capability for users to post comments on these platforms.


The second discusses how to use platforms with character space limitations, such as Twitter, and ensure fair balance is included.

  • Key Takeaway: Include fair balance in all company-created content, even on social media posts. If the pros and cons of a drug cannot be summed up in 140 characters, “then the firm should reconsider using Twitter for the intended promotional message.”
  • Key PR Considerations: Given the space limitations, social media sites such as Twitter simply are not feasible for many promotional product communications, especially for products that have complex indications or extensive risks. Currently, the brands that are most successful on Twitter use it for news, unbranded campaigns, disease states, company brand engagement and two-way communication about general updates to their followers.


The final addresses what is considered “interactive promotional material” (i.e., promotional social media), and when and how this is subject to the FDA’s postmarketing submission requirements.

  • Key Takeaway: User-generated content, even if on a company-owned property, is not considered promotional content if the user has no affiliation with the company. Also, given the immediate nature of social media, ongoing posts can be reported to the FDA on a monthly basis and use a simplified reporting system.
  • Key PR Considerations: Monthly reporting of ongoing social media content lets companies respond immediately to users’ posts and questions as appropriate, without awaiting regulatory submission, making the concept of social media interaction much more impactful for healthcare companies.


Although many questions remain unanswered and the new guidance does place heavy restrictions on how industry can interact with consumers, it is still encouraging to see the FDA put regulations into place to guide the industry in this increasingly important and influential space. Hopefully and at minimum, pharmaceutical and medical device companies that were previously hesitant about playing in unchartered territory will have a little more confidence knowing what is allowed.