The Statement of Task

In response to growing public concern with health risks posed by approved drugs, the FDA has 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 postmarketing and make recommendations to improve risk assessment, surveillance, and the safe use of drugs. As part of its work, the IOM committee will:

  • examine 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 US health care delivery system;

  • examine 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;

  • evaluate the analytical and methodological tools employed by FDA to identify and manage drug safety problems and make recommendations for enhancement;

  • evaluate FDA’s internal organizational structure and operations around drug safety (including continuing postmarket assessment of risk vs. benefit);

  • consider FDA’s legal authorities for identifying and responding to drug safety issues and current resources (financial and human) dedicated to postmarketing safety activities;

  • identify strengths, weaknesses, and limitations of the current system; and

  • make recommendations in the areas of organization, legislation, regulation, and resources to improve risk assessment, surveillance, and the safe use of drugs.

on drug safety? Does the center have the mix of expertise, technology, scientific capacity, authority, and resources to achieve its share of FDA’s mission, to protect and advance the health of the public? Do the political, social, and economic aspects of the external environment and the expectations of other stakeholders affect the agency’s functioning? To answer some of these questions, the committee reviewed aspects of the drug safety system that it believes can be transformed to improve the monitoring and evaluation of drug safety signals and restore public confidence in the system, including:

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