Omecamtiv Mecarbil: Decisional Dilemmas and Regulatory Science – Opportunities for Improvement?

Abstract

The Food and Drug Administration (FDA) is required to make decisions that can at times be controversial, for a myriad of reasons, on the benefits versus risks for medical products. This is understandable as science accelerates but with a suboptimal or more complex evidence generation system. For guidance on some of these decisions, the FDA occasionally asks an advisory committee to weigh in on particularly vexing problems. While not required, and often the issues are boiled down to just a few key topics, the process helps provide additional input into ‘yes’ or ‘no’ decisions.