FDA, MIT Partner To Detect Drug, Device Risks
FDA and the Massachusetts Institute of Technology on Thursday announced plans to co-develop an automated system that will search existing federal and private health care databases to monitor potential problems with prescription drugs and medical devices, Long Island Newsday reports. The current review system involves the manual inspection of reports voluntarily submitted to FDA.
According to Scott Gottlieb, FDA's deputy commissioner for scientific and medical affairs, reports often are submitted months or even years after adverse events have occurred, and as a result, problems often are underreported. Gottlieb says a more automated system that would scour multiple databases -- such as those compiled by health insurance providers and agencies including the Veterans Administration -- would be superior in detecting patterns that indicate potential risks.
The system would model methods developed to identify infectious disease outbreaks, bioterrorism attacks and the spread of bird flu.
FDA also plans to publish reports for doctors that would alert them to the detected problems related to specific drugs and devices, potentially prompting doctors to reciprocate by reporting problems they discover to the FDA, according to Newsday. The reports would be similar to the CDC's Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease (Long Island Newsday, 8/17).