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2015 FDA Social Media Guidelines to Bring More Clarity?

Recently, thPhoto credit: FDA released a list of approximately 100 items of draft guidance it plans to issue or update in 2015. On the list are a few guidelines pertaining to social media, which pleases many of us in PR who have been waiting (somewhat) patiently for direction over the past few years. As we wait, we thought we’d take a moment to address a few of the highlights we can expect this year.

Of particular interest for FDA-regulated drug and device companies and their PR teams is upcoming guidance on the use of links to third-party sites in social media content. It is our hope that the FDA’s recommendations will bring some clarity to how companies should alert users that they are leaving a website owned by the manufacturer, as well as how to approach changes in content on sites linked to previously.

Also this year, the FDA is considering the industry’s feedback to its guidelines published in June 2014. The first concerns the presentation of risk/benefit information on social media platforms with character limitations. It called for companies to present risks and benefits when promoting their products on Twitter and in Google paid search links. It specified that companies should, at a minimum, include the most serious risks associated with the product, as well as a hyperlink for readers to access additional information within these posts.

The second piece of guidance offered suggestions for dealing with misinformation about products by third parties. According to the FDA, companies are not obligated to correct third-party misinformation related to their drugs and devices, but should they choose to, both positive and negative misinformation must be corrected. Companies do not need to correct every source of misinformation within a forum, but must clearly define the misinformation they are choosing to correct.

Judging by the pharmaceutical industry’s reaction to these guidelines, it appears manufacturers still have more questions than answers. While the guidelines do clear up some concerns, they don’t address whether all company posts about drugs and devices on social media are considered advertising (which seems to be the assumption from the guidance), or what specifically constitutes third-party misinformation. Others who responded felt that due to the fact the misinformation guidelines are voluntary in nature, they do not do enough to protect patients from being misled.

The FDA’s long and drawn out process of releasing social media regulations leaves many of our clients—and their PR teams—in murky waters regarding what they may and may not partake in on social sites.

What can we do in the meantime? At a minimum, healthcare teams should have a response plan in place with client-approved messaging around off-label comments, reports of adverse events and the publication of misinformation. Teams must be careful to document such postings and associated responses and share them with the company so that the information may be properly communicated back to the FDA. In addition, social media channels must make both risk and benefit information easily available to users, and when it comes to user or patient concerns, it is always best to try and move the conversation into a one-to-one format, such as a private or direct message.

Image credit: Automotive Social via Flickr

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Caitie Nolan

Caitie Nolan

Account Supervisor at MSLGROUP

Caitie Nolan is an account supervisor at MSLGROUP in the healthcare practice.

Caitie Nolan

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