The role of academia and the research community in assisting the Food and Drug Administration to ensure U.S. drug safety.
OBJECTIVE
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.
Lo Re
Vincent
V
Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021, USA. vincent.lore@uphs.upenn.edu
Strom
Brian L
BL
D016265:Conflict of Interest; D003299:Cooperative Behavior; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007373:Interinstitutional Relations; D007880:Legislation, Drug / Q000458:organization & administration; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D017891:Pharmacoepidemiology / Q000458:organization & administration; D011050:Policy Making; D011634:Public Health; D012106:Research / Q000458:organization & administration; D012308:Risk Management / Q000379:methods*; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*; D014495:Universities / Q000458:organization & administration*