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Letters
January 16, 2013

Expedited Review of New Drugs—Reply

Author Affiliations
 

Letters Section Editor: Jody W. Zylke, MD, Senior Editor.

Author Affiliations: Institute for Safe Medication Practices, Alexandria, Virginia (Mr Moore; tmoore@ismp.org); and Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina (Dr Furberg).

JAMA. 2013;309(3):236-237. doi:10.1001/jama.2012.56920

In Reply: Dr Woo describes an array of programs that the US FDA now deploys for postmarketing safety surveillance and risk management. They become more important as the agency moves toward expedited approval of more drugs with safety questions still unanswered.

In our recent review of FDA postmarketing actions taken in 2009,1 we identified 181 major safety changes, including 25 new boxed warnings and 19 contraindications, occurring a median of 11 years after approval. While marketing approval now comes quickly, we are concerned that postmarketing safety actions frequently take years and do not fully resolve the safety problems.

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