US FDA and MIT to develop drug safety monitoring capacity

The US Food and Drug Administration and the Massachusetts Institute of Technology have formed a joint venture to develop an automated system for the detection of problems in drugs and medical devices.

The idea is to use an automatic data-mining computer program that would examine databases provided by health insurers and health care providers, employing tactics developed for the identification of infectious disease outbreaks (such as avian influenza) and bioterrorist attacks.

Scott Gottlieb, the FDA's Deputy Commissioner for Scientific and Medical Affairs, noted that the present manual system relies on the assessment of reports that are voluntarilty submitted to the agency, with results sometimes failing to emerge for months or even years.