FDA released two "draft" guidance documents in June 2014 relating to social media and drug advertising.
The first, Internet / Social Media Platforms, concerns the need to correct independent third-party misinformation about both prescription drugs and medal devices. In particular, this draft Guidance is intended to address a firm's response to misinformation even if such misinformation does not appear on a firm's own forum or website. The main point of the draft Guidance is to stop firms from responding to misinformation by using misleading or untruthful information. The draft Guidance ends with some general, suggested responses to misinformation.
The second draft Guidance, entitled "Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices" is designed to address the presentation of both benefit and risk information on the Internet when such platforms (e.g., Twitter, Google search engines, etc.) limit the character spaces per message. The essential message of the draft Guidance is that touting the benefits within space limitations does not allow for a firm to ignore the risks. Thus, both risks and benefits must be addressed within character space limitations. The draft Guidance provides additional details in the form of factors to be considered when utilizing Internet /social media platforms, as well as hypothetical approaches to covering these issues.
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