FDA TO REVAMP SAFETY DATA SYSTEM

Pharmacy Times, Volume 0, 0

FDA officials are hopingto have a common Webbasedsystem to collectsafety data about drugsand medical devices within2 years. The projectwould merge and automatethe individual, laborintensivesystems run by various centers that make up the FDA.

The agency requires manufacturers to report adverse drug events (eg,potential safety issues) associated with the use of their products. Currently,those reports now come into the FDA in both electronic and paper formats.Once received, they are sorted and rerouted by hand. The new system wouldaccept the reports electronically, then automatically add preliminary analysisand context before rerouting them to the correct center for attention,explained Scott Gottlieb, MD, FDA's deputy commissioner for scientific andmedical affairs.

The data allow the FDA to identify and act on possible safety concernsabout medications and devices that already are available. Lawmakers haveurged the FDA to be more reactive to those concerns.