Healthy Skepticism Library item: 9825

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lo Re V 3rd, Strom BL.
The role of academia and the research community in assisting the food and drug administration to ensure U.S. drug safety.
Pharmacoepidemiol Drug Saf. 2007 July; 16:(7):818-25
http://www3.interscience.wiley.com/cgi-bin/abstract/114210443/ABSTRACT?CRETRY=1&SRETRY=0

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.

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.