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.
The role of academia and the research community in assisting the food and drug administration to ensure U.S. drug safety†
Version of Record online: 16 APR 2007
Copyright © 2007 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 16, Issue 7, pages 818–825, July 2007
How to Cite
Re, V. L. and Strom, B. L. (2007), The role of academia and the research community in assisting the food and drug administration to ensure U.S. drug safety. Pharmacoepidem. Drug Safe., 16: 818–825. doi: 10.1002/pds.1398
No conflict of interest was declared.
- Issue online: 28 JUN 2007
- Version of Record online: 16 APR 2007
- Manuscript Accepted: 19 FEB 2007
- Manuscript Revised: 12 FEB 2007
- Manuscript Received: 28 JUL 2006
- cooperative agreements;
- conflicts of interest
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.
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.
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.
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.