FDA Issues Draft Industry Guidance on Social Media

(Wikimedia Commons)

18 June 2014. The U.S. Food and Drug Administration issued draft guidance for medical products companies on their use of social media to communicate with patients. The agency announced yesterday the documents’ availability for comment in a blog post authored by Thomas Abrams, director of FDA’s prescription drug information office.

Abrams says the documents — one covering the use of media with character space limitations and the other on answering third-party comments in social media — aim to help provide balanced and accurate information to consumers through social media, even while the technology is evolving. FDA is taking comments on the documents for 90 days.

The agency’s proposed guidance on communicating drug or medical device information through media with character-space limitations is aimed at the use of Twitter and sponsored search links on Google or Yahoo. The document stresses the need to balance benefits and risks in the same message, even under the severe limitations of Twitter’s 140-character limit, and recommends using links to more detailed explanations if needed.

The second guidance document covers corrections to misinformation published by third parties in social media, what FDA calls user-generated content, outside of the company’s control. The guidelines do not cover situations where the company itself makes inaccurate comments about competitors on social media or third parties make unfavorable comments on a company’s own blog or discussion board. However, if the company hosts a discussion board, but has a policy of not moderating comments (except in cases of removing profanity), then the guidance would apply.

When companies need to correct misinformation on third-party sites, FDA recommends they provide accurate, non-promotional evidence correcting the false or misleading statements. The agency also recommends companies reference and focus on the misinformation, as well as identify the relationship to the company of the person correcting the record. While the guidance calls for responses being consistent with FDA labeling guidelines, companies do not need to balance benefit and risk information in their responses if those features are not required in the response, but still provide a link to FDA label information.

Read more:

• FDA Proposes Accelerated Medical Device Approval Process
• Biotech Group Issues Clinical Trial Data Sharing Guidelines
• Many Large Clinical Trials Remain Unpublished
• FDA to Limit Oversight to Medical Device Mobile Apps
• Food Industry Establishes Traceability Research Center

Hat tip: FirstWord Pharma

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