Rethinking Risk Communication

Bill George, former CEO of Medtronic, Susan Alpert, MD, PhD, chair of the RAPS board, and Bogdan Dziurzynski, president of RAPS, agreed that the way risks and benefits are communicated to patients must be rethought, and that postmarket monitoring and communication efforts need to be greatly expanded.The question is, how to pay for that. Alpert suggested that premarket clearance be rethought of as a "learner's permit" rather than a stamp of approval. It would enable products to come to market quickly in limited applications, and then expand to other applications once more extensive postmarket testing was done and no red flags were raised. However, she said, "regulators are not going to want to give up premarket [authority] in order to do more postmarket."