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COPYRIGHT 2006 International Medical News Group
The Food and Drug Administration should shift its emphasis from the preapproval period to postmarkethag, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.
Many safety-related issues in recent years--including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants--have led to a lack of confidence in drug development and regulation, according to the IOM panel's 15 experts.
"The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years," the committee said in its report.
The...
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