Some Thoughts on FDA’s Draft Guidance for Social Media
Finally, the FDA has released a vague outline of its draft guidance for social media. This is something the healthcare industry and in particular, the pharmaceutical business has been waiting on for years.
The best news for communicators overall is the indication that FDA is not going to hold communicators responsible for things they cannot control. The final guidance is expected by July 9, 2014, but the draft guidance does provide clues on what the FDA is thinking, and gives healthcare communicators some useful direction. FDA is asking for comment over the next 90 days, and this link provides the detail: Fulfilling Regulatory Requirements for Post-Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.
The draft guidance probably raises more questions than it answers but one message is clear and that is when pharmaceutical companies and their agencies must report information to the FDA. The biggest concern about unregulated social media has always been how adverse events and off-label usage promotion must be submitted to FDA.
Many drug companies have avoided social media because of the fear that User Generated Content (UGC as FDA refers to it) might get them in regulatory trouble. The FDA is now stating that it isn’t necessarily the manfacturer’s responsibility to monitor and report on the whole of User Generated Content on the world wide web. However, the pharma company IS responsible if it starts the online conversation by hosting web events like tweet chats, placing editorial content on a website, or through web advertising. Under this guidance, it appears the individual company would be responsible for reporting any adverse events/side effects that healthcare consumers might discuss in that kind of conversation.
Under the expected new rules, pharma companies should submit their digital properties, i.e., Facebook, Twitter, blogs, etc., to FDA via Form 2253 or Form 2301 at least monthly, which is a change from every time they do something online. It doesn’t matter if the pharma or the agency creates the content, the entire company is responsible. This is actually standard procedure already for most companies based on previous FDA rules. In fact, FDA has said all along that it applies the same regulatory standard to internet/social media materials as it does to other promotional materials. Fair balance is still key. Based on this, my favorite form of social media to recommend in this industry is still YouTube, because you have the capacity to turn the comments section “off.”
Hopefully six months from now, we’ll have a much clearer picture of how the medium of social media can be used more effectively to educate and interact with healthcare consumers. The next regulatory hurdle may well be “mobile”—how geolocator tools and individual health monitoring apps may change the game again…