FDA Issues Draft Guidances on Social Media/ Internet Information


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-19-2014 15:41

  
The US Food and Drug Administration has issued two draft guidances relating to information appearing on social media and the Internet. One guidance describes how pharmaceutical manufacturers, packers, and distributors should address misinformation on prescription drugs and medical devices from third parties that appear on the Internet and social media platforms. The second draft guidance addresses risk and benefit information of pharmaceuticals and medical devices as presented on Internet/social platforms that have space limitations, such as Twitter and online paid searches.

The first draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, describes FDA’s current thinking about how manufacturers, packers, and distributors (for purposes of the guidance, collectively called "firms") of prescription human and animal drugs and medical devices for human use should respond, if they choose to respond, to misinformation related to a firm’s own FDA-approved or -cleared products when that information is created or disseminated by independent third parties on the Internet or through social media or other technological venues (Internet/social media), regardless of whether that misinformation appears on a firm’s own forum or an independent third-party forum or website. The draft guidance responds to stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party. The draft guidance does not apply when a firm is responsible for the product communication that contains misinformation.

The draft guidance explains that the information created by third parties (which for purposes of the guidance is user-generated content (UGC)) might appear on an interactive portion of a firm-controlled website or other interactive Internet/social media platform, or information might appear on a website or other Internet/social media platform that is independent of, or not under the control or influence of, a firm. Many Internet/social media platforms allow for real-time and continuous communications and interactions (e.g., blogs, microblogs, social networks, online communities, and live podcasts) while other platforms do not provide a means for interactive content to be posted. Whether a forum is interactive may affect the means by which a firm is able to respond to information. 

The draft guidance notes that although the Internet has facilitated the transmission of information, allowing patients and other interested parties the opportunity to share experiences as well as to communicate with other about drugs and devices, UGC might not always be accurate and may be dangerous or harmful to the public health. For the purposes of the draft guidance, misinformation is defined as positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm.

This draft guidance sets forth approaches a firm may use once it decides to voluntarily correct misinformation about its own product that is created or disseminated by an independent third party who is not under the firm’s control or influence. The draft guidance specifies that a firm may choose to provide appropriate truthful and non-misleading corrective information or, alternatively, it may provide a reputable source from which to obtain the correct information, such as the firm’s contact information. Because risk and other information about the product are not necessarily part of corrective information, FDA-required labeling should be included or provided in a readily accessible format. As two examples, a firm may provide a link that goes directly to the FDA-required labeling or may provide a link that opens a new window to a portable document format (PDF) file. The information should not be provided by including a link to a promotional website even if the information is available on the promotional website, according to the draft guidance.

The second draft guidance, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,  describes FDA’s current thinking on the communication of benefit and risk information on Internet/social media platforms with character-space limitations. The draft guidance describes how manufacturers, packers, and distributors (collectively called "firms") of prescription human and animal drugs and medical devices for human use that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling of their FDA-regulated medical products on electronic/digital platforms that are associated with character space limitations—specifically on the Internet and through social media or other technological venues (Internet/social media). Examples of Internet/social media platforms with character-space limitations include online microblog messaging (e.g., messages on Twitter or "tweets," which are currently limited to 140 character spaces per tweet) and online paid search (e.g., "sponsored links" on search engines such as Google and Yahoo, which have limited character spaces as well as other platform-imposed considerations.

The draft guidance does not address promotion via product websites, webpages on social media networking platforms (e.g., individual product pages on websites such as Facebook, Twitter, YouTube), and online web banners, as the FDA says it believes that these specific types of Internet/social media platforms do not impose the same character-space constraints as online microblog messaging and online paid search. This draft guidance also does not address responsive web design or other technology-specific layout features that may result in product-promotion presentations that differ depending on the technology used to view them (e.g., desktop computer monitors, mobile devices, tablets).

Source: FDA Draft Guidances (Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devicesand Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices 



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