Drug Safety System Is Under Way

Published Online: Wednesday, November 1, 2006

The FDA and Massachusetts Institute of Technology are developing an automated system to identify unanticipated problems with prescription drugs and medical devices. The system would search federal and private health care databases for atypical and emerging patterns that could indicate potential safety concerns.

The agency's current system relies mainly on the manual assessment of reports voluntarily submitted to the FDA. The reports sometimes come months or years after an event has occurred. A more technologically advanced system capable of watching multiple databases would be better at detecting patterns suggestive of emerging problems, noted Scott Gottlieb, MD, the FDA's deputy commissioner for scientific and medical affairs. He added that the system would be built on methods created to identify infectious disease outbreaks, detect bioterrorism attacks, and model the spread of the avian flu.

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