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U.S. Department of Health and Human Services


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Part 3: How Does FDA Conduct Postmarketing Surveillance And Risk Assessment?

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

Previous Section : Conclusions and Recommendations

It is simply not possible to identify all the side effects of drugs before they are marketed.


Wood, Stein, and Woosley, New England Journal of Medicine, 339, pp. 1851-1854 (1998)


The second area the Task Force was asked to evaluate is FDA's postmarketing surveillance and risk assessment and its strengths and weaknesses. A vital part of FDA's mission is to ensure that medical products currently available in the United States are safe and effective. The Agency monitors marketed human medical products for unexpected adverse events. FDA surveillance programs alert the Agency to potential threats to the public health and help Agency experts identify the need for preventive actions, such as changes in product labeling information and, rarely, re-evaluation of an approval decision.

The Task Force believes that FDA's postmarketing surveillance and risk assessment programs are successfully accomplishing the purposes for which they were designed. However, recent regulatory changes, an increasingly complex healthcare environment, and the emerging global marketplace present challenges to existing systems. For these reasons, FDA has been reassessing its surveillance approaches to ensure their continued effectiveness in monitoring the safety of marketed human medical products.

This Part of the report describes the Agency's ongoing postmarketing surveillance and risk assessment programs. We outline briefly efforts that are underway to enhance these programs. Finally, we identify some options for further enhancing the Agency's postmarketing program.

Next Section : Overall Postmarketing Risk Assessment is complex