FDA taps MIT for drug safety technology

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The automated system would use methods already employed for identifying outbreaks of infectious disease and modeling the spread of bird flu, and would do away with the current system that requires the FDA to manually assess voluntary reports, which can delay action on problematic drugs or devices for months or even years. According to Dr. Scott Gottlieb, the FDA's deputy commissioner for scientific and medical affairs, such delays have caused problems to be underreported in the past.

The automated system would scan federal and private healthcare databases in real time, searching for emerging or unusual patterns that could point to possible problems. Gottlieb says the new system's ability to mine information quickly and efficiently -- including databases created by health insurance providers such as the Veterans Administration -- would allow the FDA to better monitor emerging problems.

The FDA will also begin publishing reports to regularly alert doctors to potentially problematic drugs and devices, which would hopefully prompt them to be on the lookout for similar problems to report to the FDA.

Creation of the tracking system comes after criticism from lawmakers and health experts following the FDA's sluggish response in removing the painkiller Vioxx from the market in 2004.

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