5 Key Takeaways From the FDA’s Draft Guidance On Presenting Risk/Benefit With Character Limitations


The FDA recently released two documents providing draft guidance on the utilization of particular aspects of social media. The first was entitled, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices. The second was entitled, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, which is the focus of this post.

While not as clear or concise as their other previous guidance releases, there are 5 key things digital marketers need to be aware of, some of which potentially muddying the waters more then originally planned.

1. Brands may present product claims within character–limited setting, but must include several elements to be considered compliant.

If and when a brand or product chooses to put claim information inside of a tweet, the claim must contain several elements, including:

  • The product and generic name
  • Appropriate balance for the claim being made
  • A direct link to a page containing more complete discussion of the associated risks of the product

The example used by the FDA is for a fictitious product, NoFocus, with the structure of the tweet illuminating the requirements.

NoFocus (rememberzineHCL) for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk

When presenting balance to a claim, the brand or product does not need to present the full risk statement, but instead is required to communicate, “the most serious risks associated with the product.”

2. Utilization of link shortening programs was not specifically detailed in the guidance, which may end up requiring brands to rethink their URL strategy.

In the above example, the direct link to the risk information is clearly identifiable by the URL being presented. The FDA guidance did not define whether this was a requirement for the sake of clarity to a viewer, only that the link must take the user directly to a page discussing the risk of the product. When I use something like HootSuite’s link shortener, that URL becomes http://ht.ly/ybYGj. Obviously, this is less transparent to the user.

Without clarification one way or the other, brands may want to play it safe and leave the full URLs visible in the tweet. From a sub-level domain standpoint, brands can easily set up landing pages or vanity URLs to keep the character limitations short (i.e., /risk), but top-level domains might have longer names. Given the relatively limiting space 140 characters provides, and the requirements to include the other elements, means brands may want to reserve additional domains (which in and of themselves can’t be promotional in language) to keep the characters to a minimum.

3. Landing pages are required that clearly discuss the risks of a product.

The requirements in the guidance insist that a “destination is devoted exclusively to the communication of risk information about the product.” While these kinds of pages may exist in some form or another already, specified ‘risk’ optimized pages will probably become standard deliverable for twitter-like campaigns in the future.

4. The FDA finally clarified its position on using Sitelink extensions.

This is an area that’s been anticipated by a number of brands for a while now. When using Sitelink extensions for websites, brands may now include product information in the meta-data of what the search returns in the Sitelink format. The listing must contain the following information:

  • The product and generic name
  • The specific indication for the product
  • A link to information about the most serious risks
  • Links to information about any risks that are known to be fatal or life threatening
  • Links to the ISI

The example from the FDA guidance illustrates the appropriate presentation.

Screen Shot 2014-06-18 at 3.14.37 PM


5. The FDA may have inadvertently killed Sitelinks.

While seeking to offer a solution to a problem, the ability to use Sitelinks, the FDA may have effectively killed its use. In attempting to create a framework for ensuring a balanced presentation of content, the FDA has created a situation where almost all of the information being presented is about risk. While accurate, this may deter brands from utilizing Sitelinks, sine it will portray an overly negative view of their products to information seekers. While this obviously doesn’t apply to all brands, it could be a deal-breaker for most.


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