Advertising and Promotion Regulatory Affairs Conference

The regulatory boundaries in distinguishing scientific exchange from promotion can often seem blurry, apart from a limited number of long-recognized forms of scientific exchange. However, the “full exchange of scientific information” includes more than purely reactive and rather limited proactive communications by regulated companies. Proactivity is just one factor to consider when determining whether a communication is subject to FDA regulation or is a protected form of speech. However, it is clearly not determinative. This session will explore the statutory support for scientific exchange, how this type of communication can avoid allegations of promotion, and measures companies can take to maintain the distinction and reduce associated risk.