FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how pharmaceutical and medical device companies should deal with independent third-party misinformation, including user-generated content (UGC). The other addresses how the industries may be able to use platforms with character space limitations, such as Twitter. Although addressing two different topics, the draft guidance documents do have one common theme according to Thomas Abrams, the Director of the FDA's Office of Prescription Drug Promotion: they both aim to "ensure that the information provided by drug and device companies is accurate and will help patients to make well-informed decisions in consultation with their health care providers." With that goal in mind, this advisory outlines key points from both of the draft guidance documents.

FDA June 2014 Draft Guidance #1: Internet/Social Media Platforms—Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

What Is Covered -

This draft guidance applies to: (1) misinformation that is (2) posted by independent third parties. In order for the guidance to apply, the subject content must satisfy both criteria. The draft guidance defines "misinformation" as both "positive or negative incorrect representations or implications about a firm's product . . ." In order to come within the purview of the draft guidance, the misinformation must also be within content generated by an independent third party, regardless of where it appears: "the draft guidance applies when a firm is not responsible for a product-related communication that appears on the firm's own forum, an independent third-party website, or through social media. . . ." In other words, comments on the company's own website (including UGC), if made by an independent third party, are covered by the draft guidance.

Please see full advisory below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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