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Social Media Guidance from FDA: Our Take

Social Media Guidance from FDA: Our Take

June 18, 2014 0 Comments

The U.S. Food and Drug Administration (FDA) yesterday issued draft social media guidance aimed at communicating within character limits and addressing drug misinformation. In each instance, the FDA suggests fair, flexible guidance that will inform social media activity in the pharmaceutical industry for years to come.

The draft guidance is a clear signal that the FDA is listening to our industry as we strive (and sometimes struggle) to communicate product information via social media with the least amount of risk.

In the first draft guidance, “Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” marketers are given guidance on working with risk and benefit information in character-limiting social media channels. Since the advent of Twitter, a limit of 140 characters has been fraught with peril yet offers promise. Trying to wedge benefits and risk information remains a challenge, but this new draft guidance gives marketers clarity on what can constitute a “risk-free” tweet.

In a blog post today, Tom Abrams, director of FDA’s Office of Prescription Drug Promotion, reminds us of our obligations to marry benefits with appropriate risk information: “We understand that communicating on electronic Internet sites with character space limitations can be challenging. But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.”

Among the points made within the guidance, these stand out most for pharmaceutical and medical device marketers:

  • The primary guidance is that risk information, benefit information, and a link to the full ISI must be present within the same message. This is a crucial point to understand. Some companies have taken the approach that the ISI placed in a Twitter cover photo protects them if any Tweets included benefit information. The FDA clearly states that is not sufficient, and it all has to be included within the same 140-character message. These companies now need to rethink their approach to communicating on Twitter.
  • The FDA went to great lengths to assure the guidance remains flexible. While Twitter was used as an example, the FDA does not limit their guidance to a specific channel. The FDA specifically indicated that this does not apply to Facebook, YouTube or other destination sites because they do not have space limitations. We can expect this to hold up over time as a result.
  • The link to the ISI is also interesting. The FDA states that the link must go to a page solely dedicate to presenting risk information. It cannot go to a product homepage that has both benefit and risk information. For some brands, this may require the creation of an additional page on their own sites. In addition, the FDA also encourages companies to use clear URLs as opposed to URL shorteners for their risk information. They do not object to URL shortening services entirely, but state a preference for clearly labeled URLs.
  • While the FDA does not expressly prohibit social media for black-box products, it does make several mentions that it is important to consider the complexity of both the benefit and risk information before selecting social media as an appropriate channel.
  • Interestingly, in communicating risk information, the FDA does not require you to communicate the full risk information in each message. Instead, it asks companies to communicate the most serious risk associated with the product. It may be that companies need to designate their “social media risk information.”

The second piece of draft guidance was more direct. “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Misinformation” deals with correcting misinformation that stems from independent, third-party content. A few key points to highlight:

  • The guidance is clear to call out that misinformation can be both positive or negative and that the FDA feels there might be a public health benefit to correcting misinformation.
  • The guidance makes clear that responsibility is defined at the content level, not at the site level. Put another way, companies are not responsible for correcting user-generated content on sites where they have a presence, and are only responsible where they have an influence on the content itself.
  • In the case of UGC that is independent, companies are not responsible for correcting misinformation but are permitted to do so if they so choose.
  • Correcting misinformation does not carry with it an obligation to continue monitoring that site.
  • The FDA also recognizes that companies cannot control whether site administrators comply with a request to correct site information.

We continue to anticipate further FDA draft guidance around social media. What encourages us from this batch is that rather than addressing specific channels, the FDA chooses to address questions and issues that have arisen among pharmaceutical and medical device marketers as social media proliferates within the industry. Our take is that continued guidance along these lines will offer more opportunities for us and our clients as we grow the practice and use of social media.

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