Understanding the FDA’s Draft Guidance on Social Media

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Now that the FDA has released two draft guidances clarifying social media use, it’s time to determine how to apply it in a real world scenario. First, let’s define what the guidances apply to.

The first deals with the dissemination of information regarding prescription drugs and medical devices. The second makes recommendations on how to correct third party misinformation about prescription drugs and medical devices. The FDA has issued these guidances in response to requests for social media best practices, and to ensure that information given to patients about prescription drugs and medical devices is accurate and balanced.

During the Social Media Draft Guidance webinar on July 10, the FDA defined “interactive promotional media” as: “Modern Tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs.”

 

Here is the breakdown of what the FDA guidance means:

  • Risk and benefit information get equal billing, even on Twitter.  Although they recognize the challenges in providing comprehensive information in 140 characters or less, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” Additionally:
    • Benefit information should be non-misleading and transparent regarding factual information within individual social media posts.
    • Benefit information should be balanced with risk information within individual social media posts.
    • If a firm is not able to provide risk and benefit information within the space limitations of that social network, the firm should reconsider using that platform.
    • Risk information should be presented concurrently with benefit information within individual social media posts.
    • At a minimum, the most serious risks associated with the product should be included within individual social media posts.
    • Posts should include links to another source with more detailed information on the risks associated with the product.
    • Firms are able to use commonly recognized symbols instead of words, punctuation marks, and scientific abbreviations.
    • Firms are allowed to correct misinformation posted by third-party websites or blogs. While the FDA considers correcting information a voluntary activity, they require that the correction is not misleading. For example:
      • Firms cannot be the source of the misleading information.
      • FDA-required labeling should be included via non-promotional link.
      • Regardless of technological limitations, i.e., a blog or website that does not allow comments, a firm may attempt to correct misinformation by:
        • Contacting the party responsible for the misinformation, and providing the correct information, requesting that the misinformation be removed, or asking the responsible party to remove the information.
        • Firms are NOT responsible if the responsible party refuses to change or remove the misinformation.
  • “Appropriate corrective information” responses must be:
    • Pertinent and address the misinformation
    • Limited and specific to the incorrect information
    • Non-promotional in nature, tone, and presentation
    • Accurate
    • Consistent with the FDA-approved labeling for the product
    • Supported by substantial evidence
    • Posted in relation to the misinformation, or reference the misinformation
    • Disclose affiliation with the firm that manufactures, packs, or distributes the product.

It’s important to note that firms do not have to keep records of corrective information, but the FDA recommends doing so for use in responding to Agency questions.

Social media is especially tricky for the healthcare industry given HIPPA Security Rule requirements, but the FDA has stepped up in recognizing the value of it as a resource. As such, these guidances are the first in what will be a series of social media and internet related matters for the Agency.  Read more on how healthcare organizations can enter the digital landscape on the Gremln blog, or follow us on Twitter @Gremln.

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