FDA, MIT to collaborate on drug safety
WASHINGTON - The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement 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 typically are underreported, said Dr. Scott Gottlieb, the FDA’s deputy commissioner for scientific and medical affairs.
A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies like the Veterans Administration, would be better at recognizing patterns suggestive of emerging 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 for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.
Lawmakers and others have stepped up their criticism of FDA safety monitoring efforts in the wake of the pain killer Vioxx being pulled from the market in 2004.
One problem is the FDA cannot require that drug makers conduct studies on the safety of prescription medications already on the market, a recent Government Accountability Office report concluded.
Gottlieb said he did not think the FDA needed additional authority to improve its safety monitoring, according to a copy of a speech he gave Thursday at MIT’s Center for Biomedical Innovation.