***Announcement***

 “The Future of Drug Safety: Promoting and Protecting the Health of the Public" report from the Institute of Medicine Committee on the Assessment of the US Drug Safety System was released on September 22, 2006.  

In response to growing public concern with health risks posed by approved drugs, the Food and Drug Administration (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 post-marketing 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 U.S. 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 post-market 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 post-marketing safety activities;
• identify strengths, weaknesses and limitations of the current system;
• make recommendations in the areas of organization, legislation, regulation, and resources to improve risk assessment, surveillance and the safe use of drugs.

To view the Biographies of the Committee, click here.

Meetings
The first meeting of the committee was held on, June 8, 2005. Click here for more information.

The second meeting of the committee was held on July 19 - 21, 2005. Click here for more information.

The third meeting of the committee was held on October 25-26, 2005. Click here for more information.

The fourth meeting of the committee was held on January 17-19, 2006. Click here for more information.

The fifth meeting of the committee was held on March 27-29, 2006. Click here for more information.

The sixth meeting of the committee was held on May 4, 2006. Click here for more information.

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Please note: any comments that you submit to the committee, including your name and identifying information, will not be kept confidential and will be included in a Public Access File as the National Academy of Sciences complies with Section 15 of the Federal Advisory Committee Act (FACA). The National Academies shall be authorized to use any such comments or submissions in accordance with the National Academies Terms of Use Statement.

Contact Information:
Mailing Address:
Institute of Medicine
Keck Center, 8th Floor
Board on Population Health and Public Health Practice
Committee on Assessment of the U. S. Drug Safety System
500 5th Street, NW
Washington DC, 20001

Fax: 202/334-2939
E-mail: DrugSafety@nas.edu