On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first document, Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Space Limitation Guidance), addresses advertising and promotional communications concerning prescription drugs (human and animal) and medical devices over electronic or digital platforms that limit the number of character spaces that may be used in the communication, such as Twitter and sponsored search engine results. The other draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (Misinformation Correction Guidance), discusses how manufacturers and other entities may correct certain misinformation about their products posted by independent third parties over the internet or social media without triggering otherwise applicable FDA advertising or labeling requirements. Although these guidance documents, if finalized, may provide some long-awaited clarity on the FDA’s approach to reviewing these internet/social media communications, prescription drug and medical device firms should proceed with caution. Both draft guidance documents propose detailed and extensive conditions on the use of these media platforms that warrant careful consideration and implementation by manufacturers that intend to make such communications on internet or social media platforms.
Draft Guidance Regarding Internet / Social Media Platforms with Character Space Limitations -
The Space Limitation Guidance outlines the informational content that manufacturers, packers and distributors of prescription drugs and medical devices should include in promotional communications over platforms that impose character space limitations, such as microblog messaging on Twitter, and sponsored links on search engines such as Google or Yahoo. The FDA advises that, despite the character limitations of these platforms, manufacturers seeking to make product benefit claims over such forums must include an “accurate and balanced presentation of both the risks and benefits.” In this regard, the FDA notes that character space limited platforms may not enable the meaningful presentation of balanced risk and benefit information for certain products, such as those with “complex indications or extensive serious risks.” If a firm uses a space-limiting platform to make a benefit claim, in addition to providing risk information within the space-limited platform, it should also provide a link or other mechanism for direct access to a broader discussion of risks.
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