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

Vincent Lo Re, Brian L. Strom

Research output: Contribution to journalComment/debate

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)818-825
Number of pages8
JournalPharmacoepidemiology and drug safety
Volume16
Issue number7
DOIs
StatePublished - Jul 2007

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Epidemiology

Keywords

  • Academia
  • CERTs
  • Conflicts of interest
  • Cooperative agreements
  • FDA

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