The role of academia and the research community in assisting the food and drug administration to ensure U.S. drug safety

Authors

  • Vincent Lo Re III MD, MSCE,

    Corresponding author
    1. Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA
    • Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 711 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021, USA.
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    • Vincent Lo Re III is an Instructor in Epidemiology, Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Education and Research on Therapeutics at University of Pennsylvania School of Medicine.

  • Brian L. Strom MD, MPH

    1. Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA
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    • Brian L. Strom is George S. Pepper Professor of Public Health and Preventive Medicine; Professor of Biostatistics and Epidemiology; Professor of Medicine; Professor of Pharmacology; Chair, Department of Biostatistics and Epidemiology; Director, Center for Clinical Epidemiology and Biostatistics; Director, Penn Center for Education and Research on Therapeutics; Associate Vice Dean, University of Pennsylvania School of Medicine; Associate Vice President for Strategic Integration, University of Pennsylvania Health System.


  • No conflict of interest was declared.

Abstract

Purpose

Academia can play a prominent role in the drug safety arena, unique from that of industry, and a clearer articulation of how it could positively influence the current system is needed. We sought to examine ways that academia could expand its role in U.S. drug safety.

Methods

An ad hoc meeting of academic experts in drug safety and risk management was convened at the Institute of Medicine (IOM) in Washington, D.C.

Results

Academia should develop a stronger partnership with the Food and Drug Administration (FDA) to increase research on regulatory issues and public health questions and facilitate the prioritization of critical issues on drug safety. Such a collaboration could also facilitate the development of a network of academic centers of excellence in pharmacoepidemiology to address drug safety and risk management questions from a public health standpoint in a timely fashion. The development and testing of methodologic innovations on drug safety should also be encouraged.

Conclusions

Greater partnership between academia and the FDA could facilitate the prioritization of important issues on drug safety, allow more research questions on drug safety to be answered in a timely fashion, promote the development of networks for answering these questions, and help generate additional research ideas, ultimately providing enormous benefit to the public health. Copyright © 2007 John Wiley & Sons, Ltd.

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