Drug Safety System Is Under Way

The FDA and Massachusetts Instituteof Technology are developing an automatedsystem to identify unanticipatedproblems with prescription drugsand medical devices. The systemwould search federal and privatehealth care databases for atypical andemerging patterns that could indicatepotential safety concerns.

The agency's current system reliesmainly on the manual assessment ofreports voluntarily submitted to theFDA. The reports sometimes comemonths or years after an event hasoccurred. A more technologicallyadvanced system capable of watchingmultiple databases would be better atdetecting patterns suggestive of emergingproblems, noted Scott Gottlieb,MD, the FDA's deputy commissionerfor scientific and medical affairs. Headded that the system would be builton methods created to identify infectiousdisease outbreaks, detect bioterrorismattacks, and model the spreadof the avian flu.