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BioWorld Today Quotes Lori Leskin on FDA Proposals for Social Media Rules for Drugmakers

June 17, 2014

BioWorld Today reports that the FDA released two drafts of guidance documents that would dictate the way drug and medical device companies could utilize social media. The rules state that messages on social media must contain the risks, along with the benefits, of products, as well as be truthful and straightforward even when message length is limited. The FDA also added information on how to correct false messages from third parties. These regulations follow out of an FDA hearing in 2009 about promotional labeling for products on social media. According to the publication, drug and device makers were hoping for more lax regulations on social media such as Twitter, which limits to messages to 140 characters, but the FDA maintained the need for fair balance; where such balance is not possible, FDA recommends companies reconsider using such a platform.

According to Kaye Scholer Life Sciences Partner Lori Leskin, the FDA rules are “actually very consistent with everything the FDA has said all along” and contained no surprises. Leskin added that the guidelines failed to provide a clear definition of what constitutes a message “influenced”  by company, as drugmakers must ensure those communications follow FDA regulations to be non-misleading.

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