Recently, the United States Food and Drug Administration (FDA) released two long-awaited draft guidance documents pertaining to internet and social media:
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.
The first draft guidance outlines FDA’s current thinking concerning how manufacturers of drugs, biological products, and medical devices should respond to misinformation about their products posted by third parties on internet/social media platforms. FDA recognizes that information created by third parties is not always accurate and may be “dangerous or harmful to public health.” Therefore, the guidance provides firms various methods to correct such misinformation.
The second draft guidance focuses on FDA’s current thinking concerning the presentation of benefit and risk information on electronic/digital platforms that have character space limitations. FDA’s guidance provides examples of platforms to which the guidance applies, such as “tweets” on Twitter and “sponsored links” on search engines, like Google and Yahoo. This guidance does not cover promotion on product websites, webpages on social media networking platforms (i.e., Facebook, YouTube), or online web banners, since FDA has concluded that these forums “do not impose the same character space constraints as online microblog messaging and online paid search.”
A summary and analysis of the draft guidance documents can be found in Covington & Burling LLP’s e-alert (available here).
In addition, these new guidance documents come on the heels of a guidance issued on January 14 of this year focused on the drug industry, entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human And Animals Drugs and Biologics. Our analysis of the January 2014 Guidance is available here. FDA has said that it plans to release another draft guidance concerning the internet/social media, Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices–Use of Links, later this year.
Comments and suggestions regarding the two newly-published draft guidance documents should be submitted by September 15, 2014.