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Reports of unanticipated safety problems in drugs for patients with chronic conditions like arthritis have stimulated a variety of reform proposals for more intense monitoring, assessing and regulating marketed drugs to help ensure their safety. In response, the Food and Drug Administration (FDA) has initiated development of several programs designed to improve drug safety oversight including creating a Drug Safety Oversight Board, issuing draft or final guidance on various safety-related topics, and requesting and independent assessment by IOM of the current system. Congress has also been active on the issue of drug safety and has requested that the government conduct a review of FDA’s organizational structure and decision making process for postmarket drug safety. In addition, several pieces of bipartisan legislation have been introduced in Congress to address drug safety issues.
As physicians caring for people with cancer, ASCO continues to urge that any legislative or administrative reform take into account the very different circumstances that confront patients with life-threatening and frequently acute diseases like cancer that may be treatable only with medicines that have significant inherent toxicities.
