The United States Food and Drug Administration's Risk Management Framework

Abstract

In response to criticism that under the Prescription Drug User Fee Act, the United States Food and Drug Administration was endangering public health by shortening the review and approval process for medical products, former Food and Drug Administration Commissioner Jane Hennery appointed a task force to evaluate the effectiveness of the Food and Drug Administration in managing risks associated with medical products and their potential sources. Although the task force found that the agency identified risks prior to drug approval, it discovered that the Food and Drug Administration did not adequately define its role in postmarketing surveillance. This article provides insight on the current framework at the Food and Drug Administration, including modification of division roles under the Office of Postmarketing Drug Risk Assessment; specific motives that precipitated the creation of the risk management offices; and recent initiatives that have been implemented to increase postmarketing surveillance, reduce medication errors, and develop new methods to provide patients adequate medication information.