The IOM Drug Safety Report: Resource Implications (A Workshop)

Workshop

Challenges for the FDA: The Future of Drug Safety (A Workshop)

March 12, 2007

12:00 AM - 12:00 AM (ET)

Past

Materials

About

Workshop Background and Objectives

In 2007, the Institute of Medicine (IOM) released a report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. This report included recommendations for improving the U.S. drug safety system, and recommendations would likely entail significant new commitments for an agency that some consider to be financially strained by existing responsibilities. This workshop considered types and magnitudes of resources – including both human and financial resources – that are needed to achieve the goals of the IOM report.

Topics discussed focused on a subset of IOM recommendations which were deemed to have significant resource implications: increased FDA funding; integration of pre and post market review; enhancing post market safety monitoring; conducting confirmatory drug safety and efficacy studies; and enhancing post market regulation and enforcement.

Workshop Planning Committee

Gail Cassell (Chair), Eli Lilly and Company

Naomi Aronson, Blue Cross and Blue Shield Association

Catherine Bonuccelli, AstraZeneca Pharmaceuticals

Robert M. Califf, Duke University Medical Center

Susan Ellenberg, University of Pennsylvania School of Medicine

Elaine K. Gallin, The Doris Duke Charitable Foundation

Jane E. Henny, University of Cincinnati

Below are materials for the workshop, including an agenda and presentations.

For additional information on the workshop please visit our project page.

Contact

Carolyn Shore

cshore@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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The IOM Drug Safety Report: Resource Implications (A Workshop)

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Challenges for the FDA: The Future of Drug Safety (A Workshop)