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U.S. Department of Health and Human Services


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The Commissioner Asked The Task Force To Look Into Public Concerns About The Risk Management System

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Concerns have been raised about the effect of PDUFA

As one of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney created a Task Force to examine the current system to manage the risks associated with using medical products. She asked the Task Force to try to identify the strengths and weaknesses in the overall system, and to review FDA's role in the system. With regard to the Agency's role, the Commissioner asked the Task Force to concentrate its review in three basic areas: (1) the quality of the Agency's premarketing review and risk assessment, (2) the strengths and weaknesses of the Agency's postmarketing surveillance and risk assessment, and (3) other FDA risk assessment activities.


Part 1 of this report provides a general discussion of the risks involved in medical product use and an overview of the risk management system and FDA's role in that system. Parts 2 and 3 discuss the Agency's premarketing and postmarketing risk assessment activities. Part 4 takes a broad look at the overall risk management system and makes recommendations for creating a new systems model.


1 Lazarou, J., B.H. Pomeranz, and P.N. Corey, "Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies," JAMA, 3270z;1200-1205, 1998.

2 Although FDA devotes great attention to regulating the quality of medical products, this report does not address product quality problems.

Next Section : Part 1: Background - What are the Risks and What is FDA's role in Managing Risk?