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Cleaning up the Web: FDA Issues Draft Guidance Empowering Companies to Correct Misinformation on Internet/Social Platforms

Intouch Team

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EXECUTIVE SUMMARY

On June 17, 2014, the Food and Drug Administration (FDA) released draft guidance for drug/ device companies on correcting product misinformation posted by third parties on the Internet and in social media. In the interest of public health, the FDA acknowledges product information generated by third parties can be misleading or harmful, and there is value in companies correcting it. FDA has issued this guidance to help companies understand:

  • Whether companies are obligated to correct misinformation;
  • When it is appropriate to correct misinformation;
  • The steps to properly correct misinformation, including monitoring and filing requirements.

This is one of two guidance documents FDA released the same day; the other includes draft guidance on character-limited platforms.  Earlier this year, guidance also was issued relating to postmarketing submission requirements for promotional interactive media. Collectively, these continue the series of FDA guidance documents focused on the ever-changing world of digital communications.  

An important point to note – one that the FDA repeats twice in the document – is that, when a company chooses to correct misinformation in a truthful, non-misleading manner in keeping with this guidance, “the FDA does not intend to object if these voluntary corrections do not satisfy otherwise applicable regulatory requirements.”

In short, this guidance gives companies permission to interact with online content in new ways.

This POV provides more detail and highlights from the draft guidance, as well as recommendations for next steps for pharmaceutical and device manufacturers in light of the guidance.

UNDERSTANDING USER-GENERATED CONTENT

Before providing specific direction, the FDA reminds readers that user-generated content (UGC) is information posted by third parties to places like blogs, websites, Facebook, Twitter and YouTube. UGC is not restricted to certain types of content – it could include an article, video, tweet or comment.  The FDA reaffirms its position on UGC on company-owned or managed channels, saying:

“Firms are generally not responsible for third-party UGC about their products when the UGC is truly independent of the firm (e.g., is not produced by, or on behalf of, or prompted by the firm in any particular) regardless of whether the firm owns or operates the platform on which the communication appeared.”

In some situations, of course, it is possible that information conveyed by UGC may, intentionally or unintentionally, be inaccurate or misleading. To address this, the FDA has determined that there is value in companies correcting misinformation and has issued this guidance to help companies understand:

  • When it is appropriate to correct misinformation;
  • Whether companies are obligated to correct misinformation;
  • The steps to properly correct misinformation.

While it is clear that the FDA is interested in empowering companies to take proactive steps to correct misinformation, they also remind companies that there is a line between correcting misinformation for the public benefit, and doing so in subtly promotional ways.  The guidance states that “when a communication … goes beyond the correction of misinformation, the communication falls outside the scope of this draft guidance.” Correcting misinformation is not an opportunity to communicate promotional messages.

Additionally, the FDA recognizes that some channels impose character limitations, which have presented challenges. In response, the FDA offers the opportunity to engage and correct, to benefit the public, without running afoul of labeling requirements:

“If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any.”

WHEN CAN COMPANIES CORRECT MISINFORMATION - AND ARE THEY OBLIGATED TO?

The decision to correct misinformation is made at the discretion of the company. There is no obligation to correct misinformation, whether the content is published by a third party on a third-party site or a company-owned channel:

“This draft guidance applies when a firm is not responsible for a product-related communication that appears on the firm’s own forum, an independent third-party website, or through social media, and the firm chooses to correct misinformation about its own products contained in that communication.”

The FDA makes it clear, repeatedly using words such as “voluntarily” and “choose,” that correcting misinformation is discretionary. However, the FDA emphasizes that it will continue to hold companies accountable for communications created, published, controlled or influenced by employees, agencies or spokespersons. In those cases, the content would not be UGC and this draft guidance would not apply.

TAKING ACTION: CORRECTING MISINFORMATION PROPERLY AND KEEPING RECORDS

To assist in efforts to correct misinformation, the guidance document is fairly specific in its recommendations for an appropriate workflow.  

It assures that “FDA does not expect firms to submit correction to the Agency,” but “recommends that firms keep records to assist in responding to questions that may come from the Agency,” including the:

  • Source of the misinformation
  • Date the misinformation was located
  • Inaccurate content
  • Corrective information that was provided
  • Date the corrective information was provided

To be “appropriate corrective information,” it must:

  • Be relevant, responsive, limited and tailored (i.e., specific to the indications being discussed) - and include the date it is being posted or submitted
  • Be accurate, non-promotional, supported by sufficient evidence, and consistent with product labeling and provide a link thereto
  • Be posted where the misinformation occurs, or reference the misinformation being corrected, and make clear the scope of the correction so readers do not assume all other content on the site or forum is tacitly approved
  • Disclose that the person providing the correction is affiliated with the company

If a company operates or controls a platform or forum where UGC might be posted, the FDA recommends that companies add a disclaimer – “an overarching clear and conspicuous statement” – stating that the company does not create or control the content posted. Be aware, however, that the guidance does indicate that companies could be held responsible in situations where they solicit or influence the creation of UGC.

The guidance does provide relief for situations where a channel, like Twitter, imposes character limits.  The FDA indicates that, where limitations are present, companies can meet risk requirements by either:

  1. Including a link within the corrective information to a webpage with the label, as long as the link is not to a promotional website
  2. Including a link within the corrective information to a PDF of the label

Note that the link cannot read as promotional, regardless of its destination. So including http://bit.ly/ProductX, even if linking directly to the PI, would make the correction a promotional activity, outside the scope of this guidance.

If a company elects to correct misinformation, it’s important that they correct all of the misinformation in that section and don’t cherry-pick, correcting negative misinformation but not misinformation that casts positive light on the product.

Once the corrective information is posted or submitted, provided that it meets the eight criteria outlined, there is no requirement to monitor the content for additional comments.

SEEKING ASSISTANCE IN CORRECTING MISINFORMATION

In some cases, a company may not be able to correct misinformation with a public post to the site or forum. Perhaps a blog author has not enabled commenting, for instance. In these instances, the FDA recommends that companies reach out to the author or administrator to provide corrective information. This effort does not assign additional accountability to the company. The FDA acknowledges that “a firm cannot control whether an independent third party refuses to correct the misinformation” – or corrects it inaccurately or incompletely. While the FDA recognizes that the third party’s action (or inaction) with the corrective messaging is beyond the control of the pharmaceutical company, Intouch Solutions recommends careful documentation in situations such as this.

NEXT STEPS & RECOMMENDATIONS

Intouch Solutions recommends the following next steps, based on this draft guidance on correcting misinformation:

  1. Review the draft FDA guidance thoroughly to fully determine how it may affect your existing marketing policies, procedures and plans;
  2. Review your communication policies and communicate to your employees the potential impact on external communications, specifically discovering and correcting misinformation;
  3. Review your social media procedures and update or detail processes to listen for, identify and correct misinformation;
  4. Review your policies on spokespersons and bloggers and ensure that those individuals understand the requirements surrounding the correction of misinformation;
  5. Review your terms and conditions on your web and social properties to determine whether the guidance necessitates updates or revisions, such as adding “an overarching clear and conspicuous statement” when UGC is not created or controlled by the company.
  6. Remember this guidance is a draft document and is pursuant to comment and revision. Stay tuned.

SUMMARY

Through this draft guidance, the FDA clearly recognizes the public benefit of providing companies the choice and the correct process to correct misinformation posted on forums, blogs and social media. The criteria set forth enable companies to understand and avoid risks in corrective messaging and identify opportunities to evolve processes to identify and address situations where misinformation may occur.

As the FDA continues to provide guidance on digital communications and social media, companies must evolve their communication plans to incorporate the recommendations.  

Intouch Solutions will continue to monitor the evolution of this draft guidance and will publish updates to this POV document as appropriate.

 

For more information and ideas about correcting misinformation about prescription drugs or medical devices, contact your Intouch Solutions representative.

The information contained in this document is for general guidance on matters of interest only. Intouch Solutions makes no representations as to the accuracy or any other aspect of information contained in linked websites. The information contained in this document is not, nor is it intended to be, legal advice.

 

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