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Social Sharing – Does the FDA Like or Dislike?

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Understanding the FDA’s perspective on user-generated content (UGC) and implementing sharing widgets on pharma websites while maintaining fair balance is imperative to any pharma marketer looking to build a social media strategy. To date, the FDA has been relatively quiet on this issue but we can take direction from the recent draft guidance as well as a warning letter issued to Novartis to shed light on how the FDA evaluates shareable content.

There have been two instances of the FDA providing guidance on sharable content by way of recent draft guidance and a warning letter from 2010. Both documents provide FDA guidance but still leave room for interpretation. Below are some takeaways:

1.     The FDA believes that a company is generally not responsible for UGC that is independent of the firm.

In the draft guidance the FDA outlines circumstances when a pharma company would need to submit its promotional materials to OPDP. The FDA explains, “However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular)” suggesting marketers are not responsible for content posted or tweeted from a pharma website.

But be cautioned that an interpretation of the guidance would suggest that messages should generally not “prompt” or pose questions to the users so that they feel compelled to answer with UGC.

2.     FDA recognizes that content that is beyond the control of the company and social media promotional materials, however, including pre-populated messages in sharing widgets, should be submitted to the FDA.

The FDA issued Novartis a warning letter in July 2010 for their oncology drug, Tasigna. Novartis had a social sharing widget on their product’s website and, among other things, the FDA cited them for omission of risk and failure to submit. The FDA argued that the shared information included claims but not risk information and the one-click rule was not seen as sufficient balance in the reviewer’s eyes. Furthermore, Novartis failed to submit their pre-populated message, which the FDA considers promotional content. Most significant was what the FDA did NOT site them for. The FDA mentions in the letter, “Users may add additional comments, which are displayed separately from the Tasigna information, but users cannot edit the original text, URL, or graphics Tasgina created by Novartis.” This all but signals that the FDA views UGC beyond the control of pharma and therefore not liable. Additionally, pre-populated messages from pharma companies in sharing widgets are subject to all guidelines for promotional materials (e.g., fair balance) and should be submitted to OPDP.


Both the draft guidance and warning letter set precedence that should be observed by all pharma marketers when considering adding social sharing functionality to websites. Always submit pre-populated messages to the FDA and ensure that fair balance has been maintained in the message. Today there are many tools that support the structure required by pharma companies and have adapted their tools to accommodate fair balance. Make sure you are not prompting users to feel compelled to answer in the comment field, which could be interpreted as leading. Finally, creating an interstitial between your website and the social website is always a good idea to add an additional layer of separation.


  1. http://www.pmlive.com/blogs/digital_intelligence/archive/2014/january/fda_releases_draft_social_media_guidance
  2. http://www.sharesendsave.com/news/dissectingddmacletteronsharing
  3. https://s3.amazonaws.com/dodfullcf/wp-content/uploads/2010/09/DigitalAlert-SocialSharing-BridgeWorldwide.pdf
  4. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf



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