Preventive Care for Medical Databases
The Food and Drug Administration and the Massachusetts Institute of Technology have agreed to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.
The system would scour federal and private health-care databases in real time for unusual and emerging patterns that could indicate potential safety concerns.
The current system relies on the largely manual assessment of reports voluntarily submitted to the FDA, sometimes months or years after an event has occurred. As a result, potential problems are typically underreported, said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies such as the Department of Veterans Affairs, would be better at recognizing patterns that suggest problems, Gottlieb said.
The system would build on methods developed to identify infectious-disease outbreaks, detect bioterrorism attacks and model the spread of bird flu, he said.
The FDA also plans to begin publishing reports that would alert doctors to potential problems with drugs and devices, Gottlieb said.
Criticism of FDA safety-monitoring efforts has increased since the painkiller Vioxx was pulled from the market in 2004.
One problem is that the FDA cannot require that drugmakers study the safety of prescription medications already on the market, a recent Government Accountability Office report concluded.
-- Associated Press