Digital & Social Media

FDA Doles Out Guidance on Social a Dose at a Time

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After four long years of promising to provide manufacturers of medical products guidelines for promotional speech via the Internet and social media, the Food and Drug Administration (FDA) finally released some guidance that filled in enough blanks so that those pharmaceutical companies once hesitant to delve into the world of social media may want to reconsider that position.

Everyone expected that when the FDA put out this guidance, it would be an event—that there would be a timely release of a document that would answer all of the questions raised at the 2009 meeting at which the agency made the commitment to provide rules. Instead, rather than a clarifying event, the FDA seems to be committing itself to a process—revealing its thinking on various aspects of social media use over time and through more than one guidance.

Yesterday’s release of “Fulfilling Regulatory Requirements for Post-Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” is the latest installment. In December 2011, the agency also issued a dollop of guidance that relates back to that now legendary 2009 meeting. That release, entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, included information on how to respond to off-label requests that come through social media.

While not part of some anticipated watershed event, the most recent FDA guidance goes a long way to answering one of the key questions that companies have raised: Who is responsible for what is said on social media when it comes to medical products?

Firstly, the FDA indicated that a manufacturer would be held responsible for communications that the company generates or directs to be generated through an employee or consultant. In the case of third-party sites, drug makers also can be held accountable if they have exerted influence on the use and placement of such material. Thus, one is responsible for one’s own promotional communications, which is logical and unsurprising.

More interesting was the FDA conclusion about comments for which the drug makers would not be held responsible: “A firm generally is not responsible for (user-generated content) that is truly independent of the firm.” In other words, if the person is acting autonomously, then there is no responsibility and no review by the agency necessary. If the person making the comment works for the manufacturer in any capacity or if the drug maker has influence over a publisher, the company is responsible and comments should be submitted for review.

Cumulatively, the guidance issued thus far has answered many questions, but there are a couple of key questions left outstanding. For example, the agency still needs to clarify how best to handle adverse-event reporting and discussions that come through social media monitoring, the parameters of posting corrective information on third-party sites, and the appropriate use of links.

Bottom line: Many companies already have developed very deep and wide footprints on various digital platforms, while others have been reticent.  For companies that haven’t ventured onto social yet, the latest guidance may provide a basis for reviewing whether that caution is still warranted. And drug makers on social should make sure they are giving adequate attention to all the comments, including those on third party sites, for which they can be held accountable.

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About the author

Mark Senak

Mark Senak brings more than two decades of experience in communications, law, public health and public affairs. Author of the blog Eye on FDA, he has deep expertise in FDA regulations, including digital communications for the pharma industry. In addition to his extensive background as a lawyer, Senak is an author and frequent speaker.

A FleishmanHillard employee.