Public debate on the risks associated with using medical products often overlooks just how little is known about the various sources of risk and the system failures that result in patient injuries. Consequently, bad outcomes are sometimes attributed to the wrong cause, and remedies are proposed to target the wrong sources.
Under existing regulations, the Agency's work is aimed at reducing product defects and minimizing the occurrence of adverse events. The philosophy is that if Federal controls can eliminate most of the risks associated with using medical products, a properly informed medical community will manage the remaining risks.
The next part of this report addresses the Commissioner's questions about FDA's premarketing review and risk assessment. The Task Force discusses the rates of unexpected serious adverse events before and after implementation of PDUFA and reviews the Agency's quality control system. We also identify factors in the current development process that could be limiting the Agency's ability to identify risks during the review process.