Social media is everywhere. There is Twitter, LinkedIn, YouTube, blogs, and countless other tools and sites. Facebook now has over 900 million members. But social media is more than just social—it is also big business. People use it to research and discuss the products that they are using or considering. So, more and more, companies are creating a presence on social media to provide customers with information and join their discussions.

But this participation raises concerns, particularly regulatory concerns. What companies say or invite others to say on social media will be monitored. For companies in heavily regulated industries, the concerns are greater, particularly for those in the pharmaceutical, biologic, and medical device industries where the principal regulator, the Food and Drug Administration, has provided only limited guidance on the use of social media.

The FDA certainly recognizes the need for guidance. It describes social media guidance as among its “highest priorities,” even listing topics in development:

[R]esponding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; on-line communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation.

The problem is, while the FDA has held a public hearing on social media and is conducting surveys on its impact, the regulator has issued only one draft guidance—“Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices” (aka, draft off-label guidance). And that guidance only partly addresses social media.

But there is some potential good news: Guidance may be coming, if not for a couple of years. Congress is currently considering the Food and Drug Administration Safety and Innovation Act [PDF], which would require, within two years of its enactment, the FDA to issue guidance “regarding the promotion, using the Internet (including social media), of medical products.”

In the meantime, though, we are left with glimpses of the FDA’s thinking so far. Here is what we have seen.

Off-Label Communications