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Advertising, Marketing & Promotions Alert >> FDA Draft Guidances on Space-Constrained Social Media Marketing, and on Making Online Corrections

July 31, 2014

The Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies and other firms containing standards for promoting their FDA-approved or FDA-cleared products in space-constrained social media, and a second draft guidance governing how these companies can correct online misinformation about their own products.

Space Constraints
The first draft guidance explains that a company that chooses to present benefit information on Internet/social media platforms with character space limitations also should present risk information on these platforms that is “comparable in content and prominence” to the benefit claims.  In addition, the company also should provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.

Toward these ends, the draft guidance specifically observes that: 

  • Benefit information should be accurate and non-misleading and should reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet). 
  • Benefit information should be accompanied by risk information within each individual character-space-limited communication.
  • The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product, such as all risks from a boxed warning (which should be in bolded text), all risks known to be fatal or life-threatening, and all contraindications from the approved product labeling. 
  • A mechanism, such as a hyperlink, also should be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product. Interestingly, the draft guidance indicates that the FDA does not intend to object to the use of uniform resource locator (URL) shortening services, although it recommends that the URL or web address itself denote to the user that the landing page contains risk information (e.g., www.product.com/risk). Moreover, the draft guidance notes that the FDA may take into consideration whether claims are false or misleading or otherwise problematic based on a URL or web address that itself is promotional in content or tone. 

As the FDA notes in the draft guidance, in addition to including both benefit and risk information within space-constrained social media, there also are other applicable legal requirements to consider, including use of the product’s established name and its trade or brand name and the need to display the name of at least one specific dosage form.

Meeting all of these requirements “may pose challenges,” as the FDA itself recognizes, and an accurate and balanced presentation of both risks and benefits of a specific product may not be possible within the constraints of a particular platform. In that case, a company would be best advised to reconsider using that platform for the intended promotional message.

Online Corrections
The FDA’s second draft guidance applies to efforts by a pharmaceutical company – if it chooses to act – to correct independent third-party misinformation about its products on the Internet and social media platforms.  This draft guidance applies regardless of whether that misinformation appears on the company’s own forum or on an independent third-party forum or website. 

The draft guidance explains that a company in this situation may choose to provide appropriate truthful and non-misleading corrective information or, alternatively, may provide a reputable source from which to obtain the correct information, such as the firm’s contact information. The FDA says in the draft guidance that it recognizes that risk and other information about a product are not necessarily part of corrective information. The draft guidance provides, therefore, that the FDA-required labeling should be included or provided in a readily accessible format (e.g., a link that goes directly to the FDA-required labeling or a link that opens a new window to a PDF file) – but it should not be provided by including a link to a promotional website even if the information is available on the promotional website.

Acknowledging that it may be difficult for a company to correct all misinformation about its products in one forum, the draft guidance declares that a company that corrects one or more occurrences of misinformation is not expected to correct each piece of misinformation in an entire forum. The draft guidance indicates, however, that a company should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and correct all the misinformation that appears in that clearly defined portion.

The draft guidance also provides a number of approaches that can be used to correct misinformation, including:

  • Correcting misinformation directly on the forum; 
  • Providing the corrective information to the independent author for the author to incorporate; 
  • Requesting that the author remove the misinformation or allow comments to be posted; or
  • Requesting that the site administrator remove the misinformation or allow comments to be posted.  

Finally, the draft guidance provides that a company that has undertaken to correct misinformation is under no obligation to continue to monitor the website or communication that previously included user-generated content containing misinformation.  

 

Bottom Line

Comments on both draft guidances, which further illustrate the FDA’s acceptance of the importance of social media marketing, are due by September 15, 2014. Although neither contains anything particularly new or especially noteworthy, they will provide formal documentation of the FDA’s “current thinking” on both of these subjects once they are finalized.