Leading up to its final guidance to be released in July 2014, the FDA has released draft guidance on how pharmaceutical companies and medical device manufacturers should interact with social media platforms with regard to fair balance and brand messaging. The first part of the recently released recommendations is focused on how companies post advertising and promotional messages to Internet and social media platforms with character space limitations, such as Twitter and Google Sitelinks. The second part of the recommendations addresses how pharmaceutical and medical device companies may correct independent third-party misinformation about their brands online. While this guidance is recommended and not required, it will be beneficial for pharmaceutical companies to adopt the FDA recommendations going forward.
A brief review of the FDA recommendations is listed below, along with suggestions for practical implementation.
Internet and social media platforms with character space limitations
In its draft guidance Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, the FDA outlines its recommendations for promotion of brand and product information using Twitter and other character-space-limited communications, such as Google Sitelinks. The recommendations are direct and seek to include fair balance in each individual communication.
The most salient points are as follows:
- Reminder communications, which call attention to the name of a product but do not make claims, are exempt from this guidance
- The full indication must be used when making claims in a communication
- Benefit information should be accompanied by risk information within each individual communication
- The content of risk information presented should, at a minimum, include the most serious risks associated with the product
- A direct link to a more complete discussion of risk information about the product must be included in the communication
While a link to the ISI is adequate in such communications, the FDA further recommends that companies develop landing pages devoted exclusively to the communication of risk information about their products (e.g., www.product.com/risk). The format for the URL and landing page should clearly communicate that the destination will explain the risks associated with the product.
Many social media tools automatically use link shorteners to keep within the character space limitations of the communications. While the FDA does not directly oppose the use of shorteners, it recommends that the resulting URL denote to the user that the landing page contains risk information. (For example, prod.uct/risk clearly communicates that the destination is about risk.) Another solution to character space limitations is for the company to register shorter domain names that can then redirect to its product sites for use in social media.
One challenge that brands with black box warnings will face following this guidance, especially on Twitter, is in fully communicating risk information within a single tweet. For such brands it will be impossible to communicate all risks in the platform-restricted space; therefore, we recommend against using Twitter as a channel to communicate those products’ indications, benefits, and risks.
The FDA guidance also extends to paid search communications, such as Google Sitelinks. The Sitelinks feature displays up to 6 additional destination URLs for users to choose from when a paid search ad is displayed. In complying with the FDA’s draft guidance, most of the additional destination URLs provided by the brand would link to risk information in an attempt at fair balance, which might portray the product as riskier than it actually is. This might deter some companies from using Sitelinks to promote their products.
Correcting third-party misinformation
The second round of draft guidance from the FDA, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, seeks to improve the quality of public health information by allowing companies to correct third-party misinformation that they find online about their products. Again, these are recommendations; it is not required that a company respond to such misinformation, regardless of whether it appears on a company’s own forum or on an independent third-party forum or website.
The FDA defines misinformation as positive or negative representations or implications about a company’s product by an independent third party. There are two types of misinformation: a misrepresentation of the label, which a brand will typically want to correct, and an exaggeration of outcomes, which a brand may be tempted to leave uncorrected. The FDA recommends that companies respond to both types of misinformation.
If a company decides to correct misinformation on a third-party site, it should:
- Provide corrective information and a link to corrective information
- Post corrective information alongside the misinformation or refer to the misinformation in its response
- Limit the scope of the corrective information to be specific to the misinformation, and keep it non-promotional
- Correct positive misinformation as well as negative misinformation
- Keep records of corrective interactions
The FDA clearly states that it will not hold a company accountable for an independent third party’s subsequent actions or lack thereof after corrective information has been supplied. Further, companies do not have to continue to monitor the third-party site after information has been corrected.
While it is not feasible for a company to monitor all third-party sites for misinformation about its products, creating Google alerts (or similar) will help ensure that it is notified when user-generated content (UGC) about its products is trending. A company can then respond appropriately if they desire. However, consideration must be given to the level of time and effort that legal and regulatory teams must spend reviewing and filing the corrections versus the impact smaller third-party sites and individual bloggers can have on public health information.
Alternately, a company can and should focus its attention to more prominent third-party sites, such as WebMD, Wikipedia, and brand-specific hubs, in their quest to correct misinformation. This will maximize the intention of correcting the message while appropriately weighting the effort.
Overall, the draft guidance marks a significant milestone in the pharmaceutical industry’s ability to keep pace with other industries in the social media space where consumers are increasingly seeking out health information. This guidance has been a long time coming, and now pharmaceutical companies can jump into social media knowing they will be FDA compliant when the final guidance is released.
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