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Commentary

Protecting the Health of the Public—Institute of Medicine Recommendations of Drug Safety
Sheila Burke, Bruce M. Psaty, Ph.D., New England Journal of Medicine, 10-26-06

Psaty and Burke, two members of the Institute of Medicine committee tasked with reviewing the FDA's drug safety procedures, explain and defend their panel's findings.

The current system, in which the binary decision regarding approval essentially signals the end of information gathering, imposes a huge responsibility on CDER to make the right decision about new drugs. New post–marketing regulatory powers would provide the FDA with additional opportunities to act in a timely fashion. Scientific disagreements also tend to occur in the face of uncertainty. An ongoing systematic effort to identify safety signals, translate them into high–quality studies, and communicate the findings to patients and physicians can facilitate cultural change and foster productive scientific debate. Post–marketing evaluations of drugs can benefit all parties, including industry. For statin drugs, for instance, large, long–term trials have provided high–quality evidence about health benefits, extended the indications for use, and increased market share. For some drugs, new black-box warnings and occasional drug withdrawals are unavoidable. The timely identification, confirmation, and communication of risks and benefits are the best measure of regulatory success. With additional resources, new regulatory powers, and cultural changes, the FDA can link regulatory actions to new data in imaginative ways in an effort to improve the health of the public as well as industry.


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