FDA Distributes New Draft Guidance On Social Media

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Social media marketing, when managed and executed correctly, can lead to increased awareness, increased leads, increased sales, and improved communication with customers.

Yet, in the medical technology industry, excitement about this new and engaging channel is often overshadowed by anxiety and uncertainty.

Healthcare marketers understand the value of social media, but they may become overwhelmed by what they perceive as tight regulations or frustrated by seemingly restrictive FDA guidance.

More than four years in the making, the FDA issued social media guidance in June 2014 that finally offers the industry some direction on the use of digital media.  Unfortunately, even after such a long wait, little has changed.

The first of two new draft guidances, “Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices,” sets forth guidelines for a company’s response to user generated content on the web.

Companies can now correct misinformation, in a truthful and non-misleading manner without objection from the FDA. Alternatively, a company may also provide a reputable source from which to obtain the correct information, such as the firm’s contact information. According to the guidance, the communication should:

Companies are under no obligation to correct misinformation. Nor does correcting one instance on a website, obligate the company to correct all instances of misinformation on the site.

Note, that when the company itself is hosting the discussion, the guidance does not apply.

The other draft guidance, “Internet Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” addresses how companies should discuss risk and benefit information on platforms such as Twitter, as well as paid search links on Google where communications are limited to a specific amount of characters.

The new guidance stipulates that, regardless of character space constraints, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. Plus they must provide a link to allow for direct access to more complete risk information about the product.

The FDA provides the following example of a Tweet: NoFocus (remembrine HCI) for mild to moderate memory loss may cause seizures in patients with a seizure disorder www.nofocus.comrisk” – 134 characters, with 140 the limit. 

As you can see, inclusion of so much information within the body of the tweet, leaves very little opportunity to communicate any other message. Branded, product specific communications on platforms with character space requirements are already rare. It is doubtful this guidance will change that. In fact, if a medical device company can not achieve the balance of benefit and risk within character limits, the FDA proposes it “reconsider using that platform for the intended promotional message.”

Although these new draft guidances provide the medical technology industry with the FDA’s much anticipated position on social media, they do not provide any clear benefit to the manufacturers.

While social platforms continue to grow and expand in both numbers and participation rates, the FDA documents may have unintended negative consequences. Strict requirements are likely to discourage participation in social media, especially from traditionally conservative companies. Therefore, information available on any medical device could actually become more limited -- benefit, risk or otherwise -- and not reach the public where they expect to find it.

If you’re interested in learning more about the FDA’s history of regulatory action toward social media, or how medical technology professionals can use social media in a regulated environment, download our eBook “Social Media for Medical Technology Companies.

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