In a recent WCG webinar, Steven Beales, Senior Vice President, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, Robert Temple, the Deputy Director of CDER, and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy. They discussed overreporting SUSARs and the impact on patient safety. This whitepaper is based largely, but not solely, on that conversation.