FDA Issues Draft Guidances Regarding Social Media: Handling Misinformation and Character Space Limits


On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (“Internet/Social Media: Correcting Misinformation Draft Guidance”) and Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (“Internet/Social Media: Character Limitations Draft Guidance”). The Office of Prescription Drug Promotion (OPDP) in the Center for DrugEvaluation and Research (CDER) prepared both draft guidances, in consultation with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Veterinary Medicine (CVM). Although the draft guidances do not present binding rules or requirements, they nevertheless provide critical insight into FDA’s views on social media communications. Written comments on the draft guidances are due by September 16, 2014.

Internet/Social Media: Correcting Misinformation Draft Guidance -

The Internet/Social Media: Correcting Misinformation DraftGuidance sets forth guidelines for when and how manufacturers, packers, and distributors (collectively, “firms”) can address incorrect information about their products that is disseminated by third parties on the internet or social media. If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in the draft guidance, FDA will not object if the corrective information otherwise does not satisfy FDA’s other labeling or advertising regulatory requirements.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:


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.

© King & Spalding | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.