“To tweet or not to tweet?” is often the question for pharmaceutical and medical device companies when it comes to advertising their products in the burgeoning social media environment.
The very specific rules the U.S. Food and Drug Administration has regarding marketing for drugs and devices makes it difficult to market products on platforms like Twitter, Facebook and blogs. Counsel representing these companies should be familiar with several interpretive guidance documents the FDA released last year that help explain the agency’s thinking as it grapples with emerging and future social media platforms. The issuance of guidance on social media was required by the 2012 “Food and Drug Administration Safety and Innovation Act” (FDASIA), Section 1121. This required the FDA to, by August 2014, “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by [the FDA].” The FDA complied and issued three sets of guidance related to social media in 2014, with two more still pending. Though these guidance documents are not regulations, they represent the FDA’s current thinking and best practice is to follow and comply with them.
Spatially Challenged
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