Assessment of the U. S. Drug Safety System

Type: Consensus Study
Topics: Public Health, Quality and Patient Safety
Board: Board on Population Health and Public Health Practice

Activity Description

In response to growing public concern with health risks posed by approved drugs, the Food and Drug Administration (FDA)  requested that the Institute of Medicine (IOM) convene an ad hoc committee of experts to conduct an independent assessment of the current system for evaluating and ensuring drug safety post-marketing and make recommendations to improve risk assessment, surveillance, and the safe use of drugs.

As part of its work, the IOM committee:

  • examined the FDA's current role and the role of other actors (e.g., health professionals, hospitals, patients, other public agencies) in ensuring drug safety as part of the U.S. health care delivery system;
  • examined the current efforts for the ongoing safety evaluation of marketed drug products at the FDA and by the pharmaceutical industry, the medical community, and public health authorities;
  • evaluated the analytical and methodological tools employed by FDA to identify and manage drug safety problems and make recommendations for enhancement;
  • evaluated FDA's internal organizational structure and operations around drug safety (including continuing post-market assessment of risk vs. benefit);
  • considered FDA's legal authorities for identifying and responding to drug safety issues and current resources (financial and human) dedicated to post-marketing safety activities;
  • identified strengths, weaknesses and limitations of the current system;
  • made recommendations in the areas of organization, legislation, regulation, and resources to improve risk assessment, surveillance and the safe use of drugs.

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